Vaccines

Research

12 pages, 585 KiB

Open AccessArticle

The Immunogenicity of Monovalent Oral Poliovirus Vaccine Type 1 (mOPV1) and Inactivated Poliovirus Vaccine (IPV) in the EPI Schedule of India

by Lalitendu Mohanty, T. Jacob John, Shailesh D. Pawar, Padmasani Venkat Ramanan, Sharad Agarkhedkar and Pradeep Haldar

Vaccines 2024, 12(4), 424; https://doi.org/10.3390/vaccines12040424 - 17 Apr 2024

Viewed by 589

Abstract

Background: In 2016, the Global Polio Eradication Initiative (GPEI) recommended the cessation of using type 2 oral poliovirus vaccine (OPV) and OPV, with countries having to switch from the trivalent to bivalent OPV (bOPV) with the addition of inactivated poliovirus vaccine (IPV) in [...] Read more.

Background: In 2016, the Global Polio Eradication Initiative (GPEI) recommended the cessation of using type 2 oral poliovirus vaccine (OPV) and OPV, with countries having to switch from the trivalent to bivalent OPV (bOPV) with the addition of inactivated poliovirus vaccine (IPV) in their routine immunization schedule. The current GPEI strategy 2022–2026 includes a bOPV cessation plan and a switch to IPV alone or a combination of vaccine schedules in the future. The focus of our study was to evaluate the immunogenicity of monovalent OPV type 1 (mOPV1) with IPV and IPV-only schedules. Methods: This was a three-arm, multi-center randomized–controlled trial conducted in 2016–2017 in India. Participants, at birth, were randomly assigned to the bOPV-IPV (Arm A) or mOPV1-IPV (Arm B) or IPV (Arm C) schedules. Serum specimens collected at birth and at 14, 18, and 22 weeks old were analyzed with a standard microneutralization assay for all the three poliovirus serotypes. Results: The results of 598 participants were analyzed. The type 1 cumulative seroconversion rates four weeks after the completion of the schedule at 18 weeks were 99.5% (97.0–99.9), 100.0% (97.9–100.0), and 96.0% (92.0–98.1) in Arms A (4bOPV + IPV), B (4mOPV1 + IPV), and C (3IPV), respectively. Type 2 and type 3 seroconversions at 18 weeks were 80.0% (73.7–85.1), 76.9% (70.3–82.4); 93.2% (88.5–96.1), 100.0% (98.0–100.0); and 81.9% (75.6–86.8), 99.4% (96.9–99.9), respectively, in the three arms. Conclusions: This study shows the high efficacy of different polio vaccines for serotype 1 in all three schedules. The type 1 seroconversion rate of mOPV1 is non-inferior to bOPV. All the vaccines provide high type-specific immunogenicity. The program can adopt the use of different vaccines or schedules depending on the epidemiology from time to time. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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11 pages, 814 KiB

Open AccessArticle

Intussusception and Other Adverse Event Surveillance after Pilot Introduction of Rotavirus Vaccine in Nam Dinh and Thua Thien Hue Provinces—Vietnam, 2017–2021

by Ly Khanh Thi Le, Thao Phuong Thi Pham, Le Thi Phuong Mai, Quyet Tu Nguyen, Mai Phuong Ngoc Tran, Thien Huu Ho, Hung Hoang Pham, Sanh Van Le, Ha Ngoc Hoang, Anh Tuan Lai, Nguyen Thuy Huong, Hien Dang Nguyen, Dang Duc Anh, Makiko Iijima, Umesh D. Parashar, Nguyen Van Trang and Jacqueline E. Tate

Vaccines 2024, 12(2), 170; https://doi.org/10.3390/vaccines12020170 - 07 Feb 2024

Viewed by 868

Abstract

Rotavin-M1 (POLYVAC) was licensed in Vietnam in 2012. The association of Rotavin-M1 with intussusception, a rare adverse event associated with rotavirus vaccines, and with adverse events following immunization (AEFI) have not been evaluated and monitored under conditions of routine use. From February 2017 [...] Read more.

Rotavin-M1 (POLYVAC) was licensed in Vietnam in 2012. The association of Rotavin-M1 with intussusception, a rare adverse event associated with rotavirus vaccines, and with adverse events following immunization (AEFI) have not been evaluated and monitored under conditions of routine use. From February 2017 to May 2021, we conducted a pilot introduction of Rotavin-M1 into the routine vaccination program in two provinces. Surveillance for intussusception was conducted at six sentinel hospitals. AEFI reports at 30 min and 7 days after vaccination were recorded. Among 443 children <12 months of age admitted for intussusception, most (92.3%) were children ≥ 6 months. Of the 388 children who were age-eligible to receive Rotavin-M1, 116 (29.9%) had received ≥1 dose. No intussusception cases occurred in the 1–21 days after dose 1 and one case occurred on day 21 after dose 2. Among the 45,367 children who received ≥1 dose of Rotavin-M1, 9.5% of children reported at least one AEFI after dose 1 and 7.3% after dose 2. Significantly higher AEFI rates occurred among children given Rotavin-M1 with pentavalent vaccines (Quinvaxem^®, ComBE Five^®) compared to Rotavin-M1 without pentavalent vaccines. There was no association between intussusception and Rotavin-M1. The vaccine was generally safe when administered alone and when co-administered with other vaccines. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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24 pages, 2682 KiB

Open AccessArticle

Transcriptomic Analysis Reveals Sixteen Potential Genes Associated with the Successful Differentiation of Antibody-Secreting Cells through the Utilization of Unfolded Protein Response Mechanisms in Robust Responders to the Influenza Vaccine

by Ahmed Tawfik, Takahisa Kawaguchi, Meiko Takahashi, Kazuya Setoh, Izumi Yamaguchi, Yasuharu Tabara, Kristel Van Steen, Anavaj Sakuntabhai and Fumihiko Matsuda

Vaccines 2024, 12(2), 136; https://doi.org/10.3390/vaccines12020136 - 29 Jan 2024

Viewed by 1133

Abstract

The seasonal influenza vaccine remains one of the vital recommended infection control measures for the elderly with chronic illnesses. We investigated the immunogenicity of a single dose of influenza vaccine in 123 seronegative participants and classified them into four distinct groups, determined by [...] Read more.

The seasonal influenza vaccine remains one of the vital recommended infection control measures for the elderly with chronic illnesses. We investigated the immunogenicity of a single dose of influenza vaccine in 123 seronegative participants and classified them into four distinct groups, determined by the promptness of vaccine response, the longevity of humoral immunity, and the likelihood of exhibiting cross-reactivity. Subsequently, we used transcriptional profiling and differential gene expression analysis to identify potential genes directly associated with the robust response to the vaccine. The group of exemplary vaccine responders differentially expressed 16 genes, namely: MZB1, MYDGF, TXNDC5, TXNDC11, HSP90B1, FKBP11, PDIA5, PRDX4, CD38, SDC1, TNFRSF17, TNFRSF13B, PAX5, POU2AF1, IRF4, and XBP1. Our findings point out a list of expressed proteins that are related to B cell proliferation, unfolded protein response, and cellular haemostasis, as well as a linkage of these expressions to the survival of long-lived plasma cells. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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17 pages, 490 KiB

Open AccessArticle

Effectiveness of Adapted COVID-19 Vaccines and Ability to Establish Herd Immunity against Omicron BA.1 and BA4-5 Variants of SARS-CoV-2

by Pedro Plans-Rubió

Vaccines 2023, 11(12), 1836; https://doi.org/10.3390/vaccines11121836 - 10 Dec 2023

Viewed by 1168

Abstract

The emergence of novel SARS-CoV-2 variants has raised concerns about the ability of COVID-19 vaccination programs to establish adequate herd immunity levels in the population. This study assessed the effectiveness of adapted vaccines in preventing SARS-CoV-2 infection and the ability of the adapted [...] Read more.

The emergence of novel SARS-CoV-2 variants has raised concerns about the ability of COVID-19 vaccination programs to establish adequate herd immunity levels in the population. This study assessed the effectiveness of adapted vaccines in preventing SARS-CoV-2 infection and the ability of the adapted vaccines to establish herd immunity against emerging Omicron variants. A systematic literature review was conducted to estimate the absolute vaccine effectiveness (aVE) in preventing SARS-CoV-2 infection using adapted vaccines targeting Omicron variants. The ability of the adapted vaccines to establish herd immunity was assessed by taking into account the following factors: aVE, Ro values of SARS-CoV-2 and the use of non-pharmacological interventions (NPIs). This study found meta-analysis-based aVEs in preventing severe disease and SARS-CoV-2 infection of 56–60% and 36–39%, respectively. Adapted vaccines could not establish herd immunity against the Omicron BA.1 and BA.4-5 variants without using non-pharmacological interventions (NPIs). The adapted vaccines could establish herd immunity only by achieving >80% vaccination coverage, using NPIs with greater effectiveness and when 20–30% of individuals were already protected against SARS-CoV-2 in the population. New adapted COVID-19 vaccines with greater effectiveness in preventing SARS-CoV-2 infection must be developed to increase herd immunity levels against emerging SARS-CoV-2 variants in the population. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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13 pages, 781 KiB

Open AccessArticle

Safety and Immunogenicity Following the Second and Third Doses of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents with Juvenile-Onset Autoimmune Inflammatory Rheumatic Diseases: A Prospective Multicentre Study

by Merav Heshin-Bekenstein, Amit Ziv, Natasa Toplak, Siman Lazauskas, Danielle Kadishevich, Efrat Ben-Nun Yaari, Adi Miller-Barmak, Yonatan Butbul Aviel, Esther Saiag, Sara Pel, Ori Elkayam, Yosef Uziel and Victoria Furer

Vaccines 2023, 11(4), 819; https://doi.org/10.3390/vaccines11040819 - 10 Apr 2023

Cited by 1 | Viewed by 2083

Abstract

Background: To explore the long-term safety and dynamics of the immune response induced by the second and third doses of the BNT162b2 mRNA COVID-19 vaccine in adolescents with juvenile-onset autoimmune inflammatory rheumatic diseases (AIIRDs) compared with healthy controls. Methods: This international prospective study [...] Read more.

Background: To explore the long-term safety and dynamics of the immune response induced by the second and third doses of the BNT162b2 mRNA COVID-19 vaccine in adolescents with juvenile-onset autoimmune inflammatory rheumatic diseases (AIIRDs) compared with healthy controls. Methods: This international prospective study included adolescents with AIIRDs and controls vaccinated with two (AIIRDs n = 124; controls n = 80) or three (AIIRDs n = 64; controls n = 30) doses of the BNT162b2 vaccine, evaluated for vaccine side-effects, disease activity, COVID-19 breakthrough infection rates and severity, and anti-spike S1/S2 IgG antibody titers in a sample from both groups. Results: The vaccination safety profile was favorable, with most patients reporting mild or no side-effects. The rheumatic disease remained stable at 98% and 100% after the second and third doses, respectively. The two-dose vaccine induced comparable seropositivity rates among patients (91%) and controls (100%), (p = 0.55), which declined within 6 months to 87% and 100%, respectively (p = 0.3) and increased to 100% in both groups after the third vaccine dose. The overall post-vaccination COVID-19 infection rate was comparable between patients and controls, 47.6% (n = 59) and 35% (n = 28), respectively; p = 0.5278, with most infections occurring during the Omicron surge. In relation to the last vaccination, time-to-COVID-19 infection was similar between patients and controls, at a median of 5.5 vs. 5.2 months, respectively (log-rank p = 0.1555). Conclusion: The safety profile of three doses of the BNT162b2 mRNA vaccine was excellent, with adequate humoral response and similar efficacy among patients and controls. These results support the recommendation for vaccinating adolescents with juvenile-onset AIIRDs against COVID-19. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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15 pages, 1136 KiB

Open AccessArticle

Understanding COVID-19 Vaccine Effectiveness against Death Using a Novel Measure: COVID Excess Mortality Percentage

by Vladimir Atanasov, Natalia Barreto, Jeff Whittle, John Meurer, Benjamin W. Weston, Qian (Eric) Luo, Lorenzo Franchi, Andy Ye Yuan, Ruohao Zhang and Bernard Black

Vaccines 2023, 11(2), 379; https://doi.org/10.3390/vaccines11020379 - 07 Feb 2023

Cited by 6 | Viewed by 9241

Abstract

COVID-19 vaccines have saved millions of lives; however, understanding the long-term effectiveness of these vaccines is imperative to developing recommendations for booster doses and other precautions. Comparisons of mortality rates between more and less vaccinated groups may be misleading due to selection bias, [...] Read more.

COVID-19 vaccines have saved millions of lives; however, understanding the long-term effectiveness of these vaccines is imperative to developing recommendations for booster doses and other precautions. Comparisons of mortality rates between more and less vaccinated groups may be misleading due to selection bias, as these groups may differ in underlying health status. We studied all adult deaths during the period of 1 April 2021–30 June 2022 in Milwaukee County, Wisconsin, linked to vaccination records, and we used mortality from other natural causes to proxy for underlying health. We report relative COVID-19 mortality risk (RMR) for those vaccinated with two and three doses versus the unvaccinated, using a novel outcome measure that controls for selection effects. This measure, COVID Excess Mortality Percentage (CEMP), uses the non-COVID natural mortality rate (Non-COVID-NMR) as a measure of population risk of COVID mortality without vaccination. We validate this measure during the pre-vaccine period (Pearson correlation coefficient = 0.97) and demonstrate that selection effects are large, with non-COVID-NMRs for two-dose vaccinees often less than half those for the unvaccinated, and non-COVID NMRs often still lower for three-dose (booster) recipients. Progressive waning of two-dose effectiveness is observed, with an RMR of 10.6% for two-dose vaccinees aged 60+ versus the unvaccinated during April–June 2021, rising steadily to 36.2% during the Omicron period (January–June, 2022). A booster dose reduced RMR to 9.5% and 10.8% for ages 60+ during the two periods when boosters were available (October–December, 2021; January–June, 2022). Boosters thus provide important additional protection against mortality. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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9 pages, 255 KiB

Open AccessArticle

Effectiveness of Live Attenuated Varicella-Zoster Vaccine in Adults Older than 50 Years in Japan: A Retrospective Cohort Study

by Kazuhiro Matsumoto, Satoko Ohfuji, Kana Inohara, Masateru Akechi, Hiroko Kumashiro, Motoki Ishibashi, Shin Irie and Yoshio Hirota

Vaccines 2023, 11(2), 259; https://doi.org/10.3390/vaccines11020259 - 25 Jan 2023

Viewed by 1604

Abstract

Background: In Japan, freeze-dried live attenuated varicella-zoster vaccine BIKEN is available for adults aged ≥50 years to prevent herpes zoster (HZ). A prospective cohort study of 1200 healthy adults and 300 patients with underlying illness confirmed vaccine safety between 2016 and 2017. [...] Read more.

Background: In Japan, freeze-dried live attenuated varicella-zoster vaccine BIKEN is available for adults aged ≥50 years to prevent herpes zoster (HZ). A prospective cohort study of 1200 healthy adults and 300 patients with underlying illness confirmed vaccine safety between 2016 and 2017. However, evidence of vaccine effectiveness (VE) is limited. Methods: VE against HZ and postherpetic neuralgia (PHN) was evaluated in the vaccinated cohort of the previous safety study in a follow-up study between 2021 and 2022 and compared with unvaccinated family members. Self-administered questionnaires determined retrospective experiences of HZ and PHN diagnosis. Logistic regression estimated the VE by calculating the outcome odds ratio (OR) in vaccinated vs. unvaccinated groups: VE = (1 − OR) × 100(%). Results: Overall, 1098 vaccinated and 518 unvaccinated subjects were analysed. Between 2016 and 2022, 26 vaccinated (2.4%) and 22 unvaccinated (4.2%) subjects reported HZ diagnosis, and 3 vaccinated (0.3%) and 2 unvaccinated (0.4%) subjects reported PHN. Adjusted VE against a clinical diagnosis was 41% for HZ [−6% to 67%], with marginal significance, and 16% [−408% to 86%] for PHN. Stratification by age, sex, or comorbidities had an adjusted VE against HZ of ~40%, which was similar between strata. Conclusion: Freeze-dried live attenuated varicella-zoster vaccine reduces the risk of HZ regardless of age, sex, or comorbidities. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

10 pages, 823 KiB

Open AccessCommunication

Humoral Immune Response to CoronaVac in Turkish Adults

by Yasemin Cosgun, Nergis Emanet, Ayten Öz Kamiloglu, Evelin Grage-Griebenow, Susann Hohensee, Sandra Saschenbrecker, Katja Steinhagen and Gulay Korukluoglu

Vaccines 2023, 11(2), 216; https://doi.org/10.3390/vaccines11020216 - 18 Jan 2023

Cited by 1 | Viewed by 1110

Abstract

While most approved vaccines are based on the viral spike protein or its immunogenic regions, inactivated whole-virion vaccines (e.g., CoronaVac) contain additional antigens that may enhance protection. This study analyzes short-term humoral responses against the SARS-CoV-2 spike (S1) and nucleocapsid (NCP) protein in [...] Read more.

While most approved vaccines are based on the viral spike protein or its immunogenic regions, inactivated whole-virion vaccines (e.g., CoronaVac) contain additional antigens that may enhance protection. This study analyzes short-term humoral responses against the SARS-CoV-2 spike (S1) and nucleocapsid (NCP) protein in 50 Turkish adults without previous SARS-CoV-2 infection after CoronaVac immunization. Samples were collected before vaccination (t0), 28–29 days after the first vaccine dose and prior to the second dose (t1), as well as 14–15 days after the second dose (t2). Anti-S1 IgG and IgA as well as anti-NCP IgG were quantified using ELISA. At t1, seroconversion rates for anti-S1 IgG, anti-S1 IgA and anti-NCP IgG were 30.0%, 28.0% and 4.0%, respectively, increasing significantly to 98.0%, 78.0% and 40.0% at t2. The anti-NCP IgG median (t2) was below the positivity cut-off, while anti-S1 IgG and IgA medians were positive. Anti-S1 IgG levels strongly correlated with anti-S1 IgA (r_s = 0.767, p < 0.001) and anti-NCP IgG (r_s = 0.683, p < 0.001). In conclusion, two CoronaVac doses induced significant increases in antibodies against S1 and NCP. Despite strong correlations between the antibody concentrations, the median levels and seroconversion rates of S1-specific responses exceed those of NCP-specific responses as early as two weeks after the second vaccine dose. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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13 pages, 3383 KiB

Open AccessArticle

Pilot Study for Immunogenicity of SARS-CoV-2 Vaccine with Seasonal Influenza and Pertussis Vaccines in Pregnant Women

by Ching-Ju Shen, Yen-Pin Lin, Shu-Yu Hu, Ching-Fen Shen, Hui-Yu Chuang, Chin-Ru Ker, Der-Ji Sun, Yu-Hsuan Yang and Chao-Min Cheng

Vaccines 2023, 11(1), 119; https://doi.org/10.3390/vaccines11010119 - 03 Jan 2023

Cited by 1 | Viewed by 2248

Abstract

Background: It is well known that the implementation of routine immunizations to prevent vaccine-preventable diseases has a significant impact on the health and well-being of infants, children, and pregnant women. We aimed to evaluate the influence of influenza, tetanus toxoid, reduced diphtheria toxoid, [...] Read more.

Background: It is well known that the implementation of routine immunizations to prevent vaccine-preventable diseases has a significant impact on the health and well-being of infants, children, and pregnant women. We aimed to evaluate the influence of influenza, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine on the immunogenicity of SARS-CoV-2 vaccine among pregnant women, the priority population recommended for vaccination. Methods: We conducted a prospective study among pregnant women without previous SARS-CoV-2 infection in Taiwan. Maternal and umbilical cord blood samples at delivery were analyzed for the percentage of inhibition of neutralizing antibodies (NAbs) against the original strain, Delta, and Omicron variants of SARS-CoV-2 as well as the total antibody to the SARS-CoV-2 spike protein. We examined the association between different doses of SARS-CoV-2 vaccine in combination with influenza and Tdap vaccination, and two-dose SARS-CoV-2 vaccination with or without influenza and Tdap vaccines via a two-sample t-test. Results of p < 0.05 were considered to be statistically significant. Results: 98 pregnant women were enrolled in our study, with 32 receiving two doses of SARS-CoV-2 mRNA-1273 vaccine, 60 receiving three-dose of mRNA-1273, and 6 receiving one-dose of ChAdOx1 and two-dose of mRNA-1273. Twenty-one participants were immunized with SARS-CoV-2, influenza, and Tdap vaccines. Of these 21 individuals, there were no significant NAbs levels in maternal and cord blood samples against the Omicron variant, regardless of doses or type of SARS-CoV-2 vaccine. However, antibody responses against the wild-type and Delta variant were significantly lower in all maternal sera in the two-dose SARS-CoV-2 vaccine group. Among 32 women receiving two-dose mRNA-1273, significantly lower levels of NAbs in maternal sera were observed against the Delta variant and total antibody both in maternal sera and cord blood were observed in individuals receiving SARS-CoV-2 and influenza vaccine. Conclusion: This is the pilot study to demonstrate the effects of influenza and the Tdap vaccine on the immunogenicity of the SARS-CoV-2 vaccine among pregnant women. These results suggest that combination vaccination during pregnancy may result in immunogenic interactions. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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30 pages, 3199 KiB

Open AccessArticle

A Cost-Effectiveness Analysis of Pre-Exposure Prophylaxis to Avert Rabies Deaths in School-Aged Children in India

by Abhishek Royal, Denny John, Omesh Bharti, Ritesh Tanwar, Deepak Kumar Bhagat, Retna Siwi Padmawati, Vishal Chaudhary, Reddicherla Umapathi, Pradeep Bhadola and Adi Utarini

Vaccines 2023, 11(1), 88; https://doi.org/10.3390/vaccines11010088 - 30 Dec 2022

Cited by 10 | Viewed by 3126

Abstract

Children contribute to one-half of the total painful rabies mortalities in India. The state-of-the-art rabies mortality averting strategies need exploration for the effective implementation of pre-exposure prophylaxis (PrEP) in India. This study reports on the economic evaluation of various PrEP and post-exposure prophylaxis [...] Read more.

Children contribute to one-half of the total painful rabies mortalities in India. The state-of-the-art rabies mortality averting strategies need exploration for the effective implementation of pre-exposure prophylaxis (PrEP) in India. This study reports on the economic evaluation of various PrEP and post-exposure prophylaxis (PEP) strategies to avert rabies mortalities in school-aged children in India. A decision tree model has been developed for children in the age group of 5–15 years to evaluate various PrEP + PEP and PEP only regimens. The 2-site intradermal regimen administered on day zero and seven was chosen as the intervention [PrEP (I)]. ICER was calculated from the quasi-societal and quasi-health systems’ perspectives for the base case analysis, along with one-way sensitivity, and scenario analyses for each regimen. The incremental DALYs averted per million population with the implementation of PrEP (I) ranged between 451 and 85,069 in 2020. The ICER was reported in the range of USD 384–352/DALY averted (non-dominant) in comparison to PEP regimens from a quasi-societal perspective. PrEP (I) is reported to be ‘very cost effective’ in comparison with PEP regimens from the quasi-societal and quasi-health systems’ perspectives and reduce deaths by up to 89.9%. This study concludes that the PrEP (I) regimen is a cost-effective and life-saving strategy to avert painful mortalities due to rabies in school-aged children in India. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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15 pages, 2639 KiB

Open AccessArticle

Effectiveness of COVID-19 Vaccination with mRNA Vaccines for Patients with Cirrhosis in Hungary: Multicentre Matched Cohort Study

by Bálint Drácz, Veronika Müller, István Takács, Krisztina Hagymási, Elek Dinya, Pál Miheller, Attila Szijártó and Klára Werling

Vaccines 2023, 11(1), 50; https://doi.org/10.3390/vaccines11010050 - 26 Dec 2022

Cited by 2 | Viewed by 1935

Abstract

Patients with cirrhosis are vulnerable to hepatic decompensation events and death following COVID-19 infection. Therefore, primary vaccination with COVID-19 vaccines is fundamental to reducing the risk of COVID-19 related deaths in patients with cirrhosis. However, limited data are available about the effectiveness of [...] Read more.

Patients with cirrhosis are vulnerable to hepatic decompensation events and death following COVID-19 infection. Therefore, primary vaccination with COVID-19 vaccines is fundamental to reducing the risk of COVID-19 related deaths in patients with cirrhosis. However, limited data are available about the effectiveness of mRNA vaccines compared to other vaccines. The aim of our study was to investigate the efficacy of mRNA vaccines versus other vaccines in cirrhosis. In this retrospective study, we compared clinical characteristics and vaccine effectiveness of 399 COVID-19 patients without cirrhosis (GROUP A) to 52 COVID-19 patients with cirrhosis (GROUP B). 54 hospitalised cirrhosis controls without COVID-19 (GROUP C) were randomly sampled 1:1 and matched by gender and age. Of the cirrhosis cases, we found no difference (p = 0.76) in mortality rates in controls without COVID-19 (11.8%) compared to those with COVID-19 (9.6%). However, COVID-19 patients with cirrhosis were associated with higher rates of worsening hepatic encephalopathy, ascites and esophageal varices. Patients with cirrhosis receiving mRNA vaccines had significantly better survival rates compared to viral vector or inactivated vaccines. Primary vaccination with the BNT162b2 vaccine was the most effective in preventing acute hepatic decompensating events, COVID-19 infection requiring hospital admission and in-hospital mortality. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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10 pages, 283 KiB

Open AccessArticle

Insights on COVID-19 Vaccination in Portugal: A Qualitative Study among Health Professionals and Teachers

by Marta Estrela, Catarina Leitão, Tânia Magalhães Silva, Adolfo Figueiras, Fátima Roque and Maria Teresa Herdeiro

Vaccines 2022, 10(12), 1984; https://doi.org/10.3390/vaccines10121984 - 22 Nov 2022

Cited by 2 | Viewed by 1466

Abstract

Background: Vaccination against COVID-19 has had a major impact over the course of the pandemic, leading to a reduced number of hospitalizations and deaths. However, the mass vaccination process has been accompanied by skepticism and hesitancy since its beginning. As health professionals and [...] Read more.

Background: Vaccination against COVID-19 has had a major impact over the course of the pandemic, leading to a reduced number of hospitalizations and deaths. However, the mass vaccination process has been accompanied by skepticism and hesitancy since its beginning. As health professionals and teachers are important public health actors who can strongly intervene to reduce vaccination hesitancy among their patients and students, respectively, this study aimed to assess their main perceptions towards COVID-19 vaccination. Methods: Two focus group sessions, one with health professionals and the other with teachers, were conducted according to the COREQ checklist. Qualitative data were analyzed through theoretical thematic analysis. Results: In general, none of the groups showed vaccine hesitancy, although both groups had concerns regarding the safety and efficacy of the vaccines. The main concerns of health professionals were mostly related to the long-term impact of the COVID-19 pandemic, while teachers were more worried about the lack of access to reliable information about the COVID-19 vaccination. Conclusions: It is plausible to conclude that it is imperative to provide clear and accurate information for the population in order to avoid vaccination hesitancy. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

12 pages, 877 KiB

Open AccessArticle

Real-World Immunogenicity and Reactogenicity of Two Doses of Pfizer-BioNTech COVID-19 Vaccination in Children Aged 5–11 Years

by Gili Joseph, Elisheva Klein, Yaniv Lustig, Yael Weiss-Ottolenghi, Keren Asraf, Victoria Indenbaum, Sharon Amit, Or Kriger, Mayan Gilboa, Yuval Levy, Itai M. Pessach, Yitshak Kreiss, Gili Regev-Yochay and Michal Stein

Vaccines 2022, 10(11), 1954; https://doi.org/10.3390/vaccines10111954 - 18 Nov 2022

Cited by 3 | Viewed by 1485

Abstract

There are limited data concerning the immunogenicity and reactogenicity of COVID-19 vaccines in children. A total of 110 children, 5–11 years old were vaccinated with two doses (with a 3-week interval between doses) of the Pfizer-BioNTech COVID-19 vaccine and were followed for 21, [...] Read more.

There are limited data concerning the immunogenicity and reactogenicity of COVID-19 vaccines in children. A total of 110 children, 5–11 years old were vaccinated with two doses (with a 3-week interval between doses) of the Pfizer-BioNTech COVID-19 vaccine and were followed for 21, 90, and 180 days after vaccination for immunogenicity, adverse events, and breakthrough infections. Ninety days after the first vaccine dose, the GeoMean (CI 95%) of IgG ascended to 1291.0 BAU (929.6–1790.2) for uninfected children and 1670.0 BAU (1131.0–2466.0) for Infected children. One hundred and eighty days after receiving the first dose of the vaccine, the titers decreased to 535.5 BAU (288.4–993.6) for the uninfected children, while only a small decline was detected among infected children—1479.0 (878.2–2490.0). The neutralizing antibodies titer almost did not change over time in the uninfected children, and even elevated for the infected children. Of the 110 vaccinated children, 75.5% were infected, with only mild COVID-19 infection symptoms. Child vaccination was found to be safe, with mild, mostly local, and of short duration, reported AEs. No serious adverse events (SAEs) were reported after vaccination. The durability of two doses of vaccine in children is longer, thus a booster may not be needed as early as in adults. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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11 pages, 897 KiB

Open AccessArticle

Early Real-World Data to Assess Benefits and Risks of COVID-19 Vaccines: A Systematic Review of Methods

by Tatiane B. Ribeiro, Fátima Roque, Fidelia Ida, Ana I. Plácido, Mai Vu, Jose J. Hernández-Muñoz and Maria Teresa Herdeiro

Vaccines 2022, 10(11), 1896; https://doi.org/10.3390/vaccines10111896 - 10 Nov 2022

Cited by 1 | Viewed by 1661

Abstract

Since the authorization of the first COVID-19 vaccines in December 2020, multiple studies using real-world data (RWD) have been published to assess their effectiveness/safety profile. This systematic review aimed to characterize the methods and outcomes of studies using RWD for assessment of COVID-19 [...] Read more.

Since the authorization of the first COVID-19 vaccines in December 2020, multiple studies using real-world data (RWD) have been published to assess their effectiveness/safety profile. This systematic review aimed to characterize the methods and outcomes of studies using RWD for assessment of COVID-19 vaccines, four months after vaccine approval. MEDLINE and EMBASE were searched to identify published studies until 6 May 2021. Two independent researchers selected relevant publications and extracted data from included studies. The risk of bias was assessed using New-Castle Ottawa tools. After screening 1086 studies, 15 were included. Out of the 15 studies, 12 (80%) followed a cohort design, 8 (53%) were based on USA data, 7 (47%) assessed health care professionals, and 14 articles (93%) assessed the BNT162b2 vaccine. Data sources included institutional databases, electronic health records, and patient-generated data. The primary endpoint mainly described was SARS-CoV-2-infection. Hospitalization and mortality were assessed in 2 studies. For the comparability domain, six studies (40%) had a high risk of bias. A few months after the beginning of COVID-19 vaccination, Real-world Evidence (RWE) provided timely safety surveillance and comparative effectiveness with findings that showed similar findings to Randomized control trial (RCT). Most of the initiatives assessed BNT162b2 and were conducted in the USA and used healthcare workers’ data. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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8 pages, 1157 KiB

Open AccessCommunication

Using MicroRNA Arrays as a Tool to Evaluate COVID-19 Vaccine Efficacy

by Yen-Pin Lin, Yi-Shan Hsieh, Mei-Hsiu Cheng, Ching-Fen Shen, Ching-Ju Shen and Chao-Min Cheng

Vaccines 2022, 10(10), 1681; https://doi.org/10.3390/vaccines10101681 - 08 Oct 2022

Cited by 2 | Viewed by 2367

Abstract

In order to solve COVID-19 pandemic, the entire world has invested considerable manpower to develop various new vaccines to temporarily alleviate the disaster caused by the epidemic. In addition to the development of vaccines, we need to also develop effective assessment methods to [...] Read more.

In order to solve COVID-19 pandemic, the entire world has invested considerable manpower to develop various new vaccines to temporarily alleviate the disaster caused by the epidemic. In addition to the development of vaccines, we need to also develop effective assessment methods to confirm vaccines’ efficacy and maximize the benefits that vaccines can bring. In addition to common evaluation methods, vaccine-specific and temporal expression of microRNAs have been shown to be related to vaccine efficacy or vaccine-associated diseases. In this article, we have introduced a microRNA-array-based approach, which could be potentially used for evaluating COVID-19 vaccine efficacy, specifically for pregnant women. As the mRNA in mRNA vaccines is decomposed by host cells within a few days, it is considered more suitable for pregnant women to utilize the method of vaccination during pregnancy. Moreover, pregnant women belong to a high-risk group for COVID-19, and there is currently no appropriate vaccine to newborns. Therefore, it’s important to find improved tools for evaluation of vaccine efficacy in response to the current situation caused by COVID-19. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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10 pages, 448 KiB

Open AccessArticle

Vaccination Offer during the Occupational Health Surveillance Program for Healthcare Workers and Suitability to Work: An Italian Retrospective Cohort Study

by Francesco Paolo Bianchi, Pasquale Stefanizzi, Luigi De Maria, Andrea Martinelli, Giusy Diella, Angela Maria Vittoria Larocca, Luigi Vimercati and Silvio Tafuri

Vaccines 2022, 10(10), 1633; https://doi.org/10.3390/vaccines10101633 - 28 Sep 2022

Cited by 5 | Viewed by 1698

Abstract

The active immunization of health care workers (HCWs) is a crucial measure to avoid nosocomial infection; nevertheless, vaccine coverage (VC) among health personnel in Italy is unsatisfactory. To improve VC in the healthcare set, the Hygiene and Occupational Medicine departments of Bari Policlinico [...] Read more.

The active immunization of health care workers (HCWs) is a crucial measure to avoid nosocomial infection; nevertheless, vaccine coverage (VC) among health personnel in Italy is unsatisfactory. To improve VC in the healthcare set, the Hygiene and Occupational Medicine departments of Bari Policlinico General University Hospital applied a specific program. The operative procedure demands that in the context of the occupational medical examination, all workers are evaluated for susceptibility to vaccine-preventable diseases (VDPs), with immunization prophylaxis offered to those determined to be susceptible. This study analyzed data from workers who attended the biological risk assessment protocol from December 2017 to October 2021 (n = 1477), who were evaluated for the immune status for measles, mumps, rubella, and varicella. Among the enrolled subjects, non-protective antibody titers were higher for measles and mumps (13%), followed by rubella (11%) and varicella (8%). Appropriate vaccinations were offered to all susceptible HCWs, and HCWs were re-tested one month after immunization. The seroconversion rate after the administration of one or more booster dose(s) was over 80%. Overall, 2.5% of the subjects refused the offered vaccine(s); the main determinant of immunization compliance was younger age (aOR = 0.86; 95%CI = 0.80–0.92). Especially during the COVID-19 pandemic, VPDs may still present a hazard in nosocomial environment. Our experience suggests that, despite hospital procedures and dedicated human assets, satisfactory VC cannot be reached without the provision of federal regulations. Nevertheless, public health policymakers have to improve the promotion of vaccine prophylaxis and education to reach higher VC. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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9 pages, 613 KiB

Open AccessCommunication

Pre-Existing Comorbidities Diminish the Likelihood of Seropositivity after SARS-CoV-2 Vaccination

by Alok R. Amraotkar, Adrienne M. Bushau-Sprinkle, Rachel J. Keith, Krystal T. Hamorsky, Kenneth E. Palmer, Hong Gao, Shesh N. Rai and Aruni Bhatnagar

Vaccines 2022, 10(8), 1363; https://doi.org/10.3390/vaccines10081363 - 20 Aug 2022

Cited by 5 | Viewed by 1863

Abstract

Background: The impact of chronic health conditions (CHCs) on serostatus post-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination is unknown. Methods: We assessed serostatus post-SARS-CoV-2 vaccination among fully vaccinated adult residents of Jefferson County, Kentucky, USA, from April 2021 to August 2021. Serostatus [...] Read more.

Background: The impact of chronic health conditions (CHCs) on serostatus post-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination is unknown. Methods: We assessed serostatus post-SARS-CoV-2 vaccination among fully vaccinated adult residents of Jefferson County, Kentucky, USA, from April 2021 to August 2021. Serostatus was determined by qualitative analysis of SARS-CoV-2-specific Spike IgG antibodies via enzyme-linked immunoassay (ELISA) in peripheral blood samples. Results: Of the 5178 fully vaccinated participants, 51 were seronegative and 5127 were seropositive. Chronic kidney disease (CKD) and autoimmune disease showed the highest association with negative serostatus in fully vaccinated individuals. The absence of any CHC was strongly associated with positive serostatus. The risk of negative serostatus increased as the total number of pre-existing CHCs increased. Similarly, the use of two or more CHC-related medications was associated with seronegative status. Conclusions: The presence of any CHC, especially CKD or autoimmune disease, increased the likelihood of seronegative status among individuals who were fully vaccinated to SAR-CoV-2. This risk increased with a concurrent increase in number of comorbidities, especially with multiple medications. The absence of any CHC was protective and increased the likelihood of a positive serological response. These results will help develop appropriate guidelines for booster doses and targeted vaccination programs. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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10 pages, 1409 KiB

Open AccessArticle

Long-Term Immunogenicity of Inactivated and Oral Polio Vaccines: An Italian Retrospective Cohort Study

by Angela Maria Vittoria Larocca, Francesco Paolo Bianchi, Anna Bozzi, Silvio Tafuri, Pasquale Stefanizzi and Cinzia Annatea Germinario

Vaccines 2022, 10(8), 1329; https://doi.org/10.3390/vaccines10081329 - 17 Aug 2022

Cited by 8 | Viewed by 2129

Abstract

Oral and inactivated poliovirus (PV) vaccines have contributed toward the global eradication of wild PV2 and PV3, as well as the elimination of PV1 in most countries. While the long-term (>5–10 years) persistence of protective antibodies in ≥80% of the population vaccinated with [...] Read more.

Oral and inactivated poliovirus (PV) vaccines have contributed toward the global eradication of wild PV2 and PV3, as well as the elimination of PV1 in most countries. While the long-term (>5–10 years) persistence of protective antibodies in ≥80% of the population vaccinated with ≥3–4 doses of oral poliovirus vaccine (OPV) has been demonstrated, the duration of immunity in people vaccinated with the inactivated poliovirus vaccine (IPV) is still unclear. This study evaluated the seroprevalence of anti-PV neutralizing antibodies and the long-term immunogenicity conferred by OPV and IPV in a sample of medical students from the University of Bari (April 2014–October 2020). The levels of neutralizing PV1, PV2, and PV3 antibodies in blood samples taken during the assessments were evaluated. Neutralizing antibodies against PV1, PV2, and PV3 were present in >90% of the study participants, with rates of >99%, >98%, and ~92–99%, respectively. IPV resulted in a higher immunological response than OPV against PV3. Protective antibodies against all three viruses persisted for at least 18 years after administration of the last vaccine dose. Until PV1 is completely eradicated, maximum vigilance from public health institutions must be maintained. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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10 pages, 563 KiB

Open AccessArticle

Duration of COVID-19 mRNA Vaccine Effectiveness against Severe Disease

by Devendra Bansal, Jazeel Abdulmajeed, Maha H. M. A. Al-Shamali, Soha S. A. Albayat, Sayed M. Himatt, Farhan S. Cyprian, Tawanda Chivese, Jesha M. A. Mundodan, Hayat S. Khogali, Rekayahouda Baaboura, Anvar H. Kaleeckal, Mujeeb C. Kandy, Ali Nizar Latif, Mohamed Ghaith Al-Kuwari, Hamad Eid Al-Romaihi, Abdullatif Al Khal, Roberto Bertollini, Mohamed Hamad Al-Thani, Elmobashar Farag and Suhail A. R. Doi

Vaccines 2022, 10(7), 1036; https://doi.org/10.3390/vaccines10071036 - 28 Jun 2022

Cited by 4 | Viewed by 1994

Abstract

Waning immunity following administration of mRNA-based COVID-19 vaccines remains a concern for many health systems. We undertook a study to determine if recent reports of waning for severe disease could have been attributed to design-related bias by conducting a study only among those [...] Read more.

Waning immunity following administration of mRNA-based COVID-19 vaccines remains a concern for many health systems. We undertook a study to determine if recent reports of waning for severe disease could have been attributed to design-related bias by conducting a study only among those detected with a first SARS-CoV-2 infection. We used a matched case-control study design with the study base being all individuals with first infection with SARS-CoV-2 reported in the State of Qatar between 1 January 2021 and 20 February 2022. Cases were those detected with first SARS-CoV-2 infection requiring intensive care (hard outcome), while controls were those detected with first SARS-CoV-2 infection who recovered without the need for intensive care. Cases and controls were matched in a 1:30 ratio for the calendar month of infection and the comorbidity category. Duration and magnitude of conditional vaccine effectiveness against requiring intensive care and the number needed to vaccinate (NNV) to prevent one more case of COVID-19 requiring intensive care was estimated for the mRNA (BNT162b2/mRNA-1273) vaccines. Conditional vaccine effectiveness against requiring intensive care was 59% (95% confidence interval (CI), 50 to 76) between the first and second dose, and strengthened to 89% (95% CI, 85 to 92) between the second dose and 4 months post the second dose in persons who received a primary course of the vaccine. There was no waning of vaccine effectiveness in the period from 4 to 6, 6 to 9, and 9 to 12 months after the second dose. This study demonstrates that, contrary to mainstream reports using hierarchical measures of effectiveness, conditional vaccine effectiveness against requiring intensive care remains robust till at least 12 months after the second dose of mRNA-based vaccines. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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14 pages, 1073 KiB

Open AccessArticle

Effectiveness of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Covishield^TM) in Preventing SARS-CoV2 Infection, Chennai, Tamil Nadu, India, 2021

by Sharan Murali, Manikandanesan Sakthivel, Kamaraj Pattabi, Vettrichelvan Venkatasamy, Jeromie Wesley Vivian Thangaraj, Anita Shete, Alby John Varghese, Jaganathan Arjun, Chethrapilly Purushothaman Girish Kumar, Pragya D Yadav, Rima Sahay, Triparna Majumdar, Manisha Dudhmal, Azhagendran Sivalingam, Sudha Rani Dhanapal, Augustine Durai Samy, Vijayaprabha Radhakrishnan, Murali Mohan Muni Krishnaiah, Suresh Arunachalam, Punita Muni Krishna Gandhi, Elavarasu Govindasamy, Prabhakaran Chinnappan, Dhana Priya Vadhani Sekar, Prakash Marappan, Ezhil Pounraj, Parasuraman Ganeshkumar, Murugesan Jagadeesan, Manish Narnaware, Gagandeep Singh Bedi, Prabhdeep Kaur and Manoj Murhekar Show full author list Hide full author list

Vaccines 2022, 10(6), 970; https://doi.org/10.3390/vaccines10060970 - 17 Jun 2022

Cited by 6 | Viewed by 4401

Abstract

We estimated the effectiveness of two doses of the ChAdOx1 nCoV-19 (Covishield) vaccine against any COVID-19 infection among individuals ≥45 years in Chennai, Tamil Nadu, India. A community-based cohort study was conducted from May to September 2021 in a selected geographic area in [...] Read more.

We estimated the effectiveness of two doses of the ChAdOx1 nCoV-19 (Covishield) vaccine against any COVID-19 infection among individuals ≥45 years in Chennai, Tamil Nadu, India. A community-based cohort study was conducted from May to September 2021 in a selected geographic area in Chennai. The estimated sample size was 10,232. We enrolled 69,435 individuals, of which 21,793 were above 45 years. Two-dose coverage of Covishield in the 18+ and 45+ age group was 18% and 31%, respectively. Genomic analysis of 74 out of the 90 aliquots collected from the 303 COVID-19-positive individuals in the 45+ age group showed delta variants and their sub-lineages. The vaccine’s effectiveness against COVID-19 disease in the ≥45 age group was 61.3% (95% CI: 43.6–73.4) at least 2 weeks after receiving the second dose of Covishield. We demonstrated the effectiveness of two doses of the ChAdOx1 vaccine against the delta variant in the general population of Chennai. We recommend similar future studies considering emerging variants and newer vaccines. Two-dose vaccine coverage could be ensured to protect against COVID-19 infection. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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10 pages, 817 KiB

Open AccessArticle

Antibody- and T Cell-Dependent Responses Elicited by a SARS-CoV-2 Adenoviral-Based Vaccine in a Socially Vulnerable Cohort of Elderly Individuals

by Martin Moya, Marcela Marrama, Carina Dorazio, Florencia Veigas, Montana N. Manselle Cocco, Tomas Dalotto Moreno, Gabriel A. Rabinovich and Ariel Aleksandroff

Vaccines 2022, 10(6), 937; https://doi.org/10.3390/vaccines10060937 - 13 Jun 2022

Cited by 1 | Viewed by 2637

Abstract

Background: In spite of compelling evidence demonstrating safety and immunogenicity of adenoviral-based SARS-CoV-2 vaccines in the general population, its effects in socially vulnerable elderly individuals are poorly understood. Here we aimed to investigate the efficacy of two doses of combined vector vaccine, the [...] Read more.

Background: In spite of compelling evidence demonstrating safety and immunogenicity of adenoviral-based SARS-CoV-2 vaccines in the general population, its effects in socially vulnerable elderly individuals are poorly understood. Here we aimed to investigate the efficacy of two doses of combined vector vaccine, the Gam-COVID-Vac (Sputnik-V vaccine), at 14, 42, and 180 days after immunization, in a nursing home for underprivileged population and homeless individuals. Methods: A phase 3, open-label clinical trial involving administration of two adenoviral vectors (Ad26-Ad5) vaccine, in elderly individuals over the ages of 60 years was performed. SARS-CoV-2 Spike RBD-specific IgG antibodies at days 21-, 42- and 180 post-vaccination was analyzed in sera of individuals receiving two doses of the Sputnik-V vaccine with an interval of 21 days. SARS-CoV-2-specific CD8+ T cell responses, measured by intracellular tumor necrosis factor (TNF) was determined by flow cytometry following antigen-specific cultures. Results: A total of 72 elderly adults with a mean age of 72.6 ± 9.5 years-old was selected after applying the inclusion criteria, all corresponding to an underprivileged population. Two-doses vaccination with Sputnik-V vaccine elicited an antibody-mediated immune response (revealed by quantitative detection of SARS-CoV-2-specific IgG antibodies, CMIA) 70% at day 21, 90% at day 42, and 66.1% at day 180. Fully vaccinated individuals had robust SARS-CoV-2-specific T cell responses, evidenced by TNF production in CD4+ and CD8+ T cells in all time periods analyzed. Conclusion: Six months after receipt of the second dose of the Gam-COVID-Vac vaccine, SARS-CoV-2-specific IgG levels declined substantially among the tested population, whereas CD4+ and CD8+ T-cell-mediated immunity remained at high levels. These data suggest that two doses of combined adenoviral-based vaccine elicits a considerable level of SARS-CoV-2 immune responses in elderly individuals, highlighting its safety and immunogenicity in this highly vulnerable population. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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14 pages, 581 KiB

Open AccessArticle

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

by Amedeo Nuzzo, Simona Manacorda, Enrico Sammarco, Andrea Sbrana, Serena Bazzurri, Federico Paolieri, Fiorella Manfredi, Chiara Mercinelli, Marco Ferrari, Giulia Massaro, Adele Bonato, Alessia Salfi, Luca Galli, Riccardo Morganti, Andrea Antonuzzo, Chiara Cremolini and Gianluca Masi

Vaccines 2022, 10(6), 892; https://doi.org/10.3390/vaccines10060892 - 02 Jun 2022

Cited by 1 | Viewed by 2167

Abstract

Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients [...] Read more.

Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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14 pages, 1213 KiB

Open AccessArticle

SARS-CoV-2 Antibody and T Cell Response after a Third Vaccine Dose in Hemodialysis Patients Compared with Healthy Controls

by Benedikt Simon, Harald Rubey, Martin Gromann, Astrid Knopf-Völkerer, Boris Hemedi, Sonja Zehetmayer and Bernhard Kirsch

Vaccines 2022, 10(5), 694; https://doi.org/10.3390/vaccines10050694 - 28 Apr 2022

Cited by 10 | Viewed by 2021

Abstract

Hemodialysis (HD) patients have an increased risk of severe SARS-CoV-2 infection. In this study, we assess the impact of a third vaccine dose (3D) on antibody levels and T cell response in HD patients and a healthy control group in a prospective cohort [...] Read more.

Hemodialysis (HD) patients have an increased risk of severe SARS-CoV-2 infection. In this study, we assess the impact of a third vaccine dose (3D) on antibody levels and T cell response in HD patients and a healthy control group in a prospective cohort study consisting of 60 HD patients and 65 healthy controls. Each participant received two doses of the BNT-162b2 mRNA vaccine and an mRNA vaccine 3D. The SARS-CoV-2 antibody response was measured 6 months after the second vaccine dose and 6 to 8 weeks after the 3D. We assessed INF-γ secretion 6–8 weeks post 3D in 24 healthy controls, 17 HD patients with a normal response, and 20 low responder HD patients. The groups were compared using univariate quantile regressions and multiple analyses. After the 3D, the SARS-CoV-2-specific antibody and INF-γ titers of most HD patients were comparable to those of healthy controls. A subgroup of HD patients who had shown a diminished antibody response after the first two vaccine doses developed a significantly lower antibody and INF-γ response compared to responder HD patients and controls even after the 3D. A new strategy is needed to protect low/non-responder HD patients from severe SARS-CoV-2 infection. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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8 pages, 413 KiB

Open AccessArticle

Medium-to-Long-Term Immunogenicity of BNT162b2 mRNA COVID-19 Vaccine: A Retrospective Cohort Study

by Francesco Paolo Bianchi, Pasquale Stefanizzi, Cinzia Annatea Germinario, Giovanni Migliore, Luigi Vimercati, Andrea Martinelli, Annamaria Lobifaro, Giusy Diella, Angela Maria Vittoria Larocca, Control Room Working Group and Silvio Tafuri

Vaccines 2022, 10(3), 417; https://doi.org/10.3390/vaccines10030417 - 10 Mar 2022

Cited by 4 | Viewed by 1952

Abstract

To deal with the COVID-19 pandemic, a mass vaccination campaign was started in European countries on 27 December 2020. The first vaccine available to immunize healthcare workers (HCWs) was the BNT162b2 mRNA COVID-19 vaccine. While many studies have shown a high antibody response [...] Read more.

To deal with the COVID-19 pandemic, a mass vaccination campaign was started in European countries on 27 December 2020. The first vaccine available to immunize healthcare workers (HCWs) was the BNT162b2 mRNA COVID-19 vaccine. While many studies have shown a high antibody response after the second vaccine dose, antibody persistence over the medium-to-long term has yet to be evaluated. The medium-to-long-term persistence of anti-SARS-CoV-2 antibodies was determined in a sample of fully vaccinated HCWs at Bari Policlinico General Hospital, Italy. This is a observational cohort study. HCWs who completed the immunization basal cycle were screened for anti-SARS-CoV-2 IgG on days 15, 30, 60, 90, and 120 after the second vaccine dose. At each time point, >99% of the screened HCWs were seroprotected. While the geometric mean titer initially declined over time, by 60 days the titer had stabilized. Older subjects seem to lose IgG faster than younger ones. The immunogenicity conferred by the vaccine provides further evidence that it is an essential weapon in efforts to bring the COVID-19 pandemic under control. Accordingly, strict measures should be implemented, ranging from the mandatory vaccination of HCWs to strong incentives aimed at achieving vaccination of the large majority of the overall population. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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Review

Jump to: Research, Other

14 pages, 658 KiB

Open AccessReview

Efficacy and Safety of Vaccinations in Geriatric Patients: A Literature Review

by Tiziana Ciarambino, Pietro Crispino, Pietro Buono, Vincenzo Giordano, Ugo Trama, Vincenzo Iodice, Laura Leoncini and Mauro Giordano

Vaccines 2023, 11(9), 1412; https://doi.org/10.3390/vaccines11091412 - 24 Aug 2023

Cited by 2 | Viewed by 1598

Abstract

With the progressive lengthening of the average age of the population, especially in some countries such as Italy, vaccination of the elderly is a fixed point on which most of the public health efforts are concentrating as epidemic infectious diseases, especially those of [...] Read more.

With the progressive lengthening of the average age of the population, especially in some countries such as Italy, vaccination of the elderly is a fixed point on which most of the public health efforts are concentrating as epidemic infectious diseases, especially those of the winter, have a major impact on the progression of severe disease, hospitalization, and death. The protection of the elderly against acute infectious diseases should not only limit mortality but also have a positive impact on the fragility of these people in terms of less disability and fewer care needs. However, vaccination of the elderly population differs in efficacy and safety compared to that of other population categories since aging and the consequent loss of efficiency of the immune system lead to a reduction in the immunogenicity of vaccines without achieving a lasting antibody coverage. There are various strategies to avoid the failure of immunization by vaccines such as resorting to supplementary doses with adjuvant vaccines, increasing the dosage of the antigen used, or choosing to inoculate the serum relying on various routes of administration of the vaccine. Vaccination in the elderly is also an important factor in light of growing antibiotic resistance because it can indirectly contribute to combating antibiotic resistance, reducing theoretically the use of those agents. Furthermore, vaccination in old age reduces mortality from infectious diseases preventable with vaccines and reduces the same rate of resistance to antibiotics. Given the importance and complexity of the topic, in this review, we will deal with the main aspects of vaccination in the elderly and how it can influence mortality and healthcare costs, especially in those countries where population aging is more evident. Therefore, we conducted a systematic literature search in PubMed to identify all types of studies published up to 31 May 2023 that examined the association between vaccination and the elderly. Data extraction and quality assessment were conducted by two reviewers (PC and TC) who independently extracted the following data and assessed the quality of each study. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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15 pages, 1380 KiB

Open AccessReview

Effectiveness of COVID-19 Vaccines against SARS-CoV-2 Omicron Variant (B.1.1.529): A Systematic Review with Meta-Analysis and Meta-Regression

by Nando Reza Pratama, Ifan Ali Wafa, David Setyo Budi, Henry Sutanto, Tri Pudy Asmarawati, Gema Barlian Effendi and Citrawati Dyah Kencono Wungu

Vaccines 2022, 10(12), 2180; https://doi.org/10.3390/vaccines10122180 - 19 Dec 2022

Cited by 12 | Viewed by 3062

Abstract

Vaccine effectiveness (VE) and the urgency of booster vaccination against SARS-CoV-2 Omicron variant need evaluation. A systematic search was conducted from 1–6 April, 2022. VE difference (VED) estimates were assessed using random-effects and meta-regression analyses were performed for evaluating VE over time. Compared [...] Read more.

Vaccine effectiveness (VE) and the urgency of booster vaccination against SARS-CoV-2 Omicron variant need evaluation. A systematic search was conducted from 1–6 April, 2022. VE difference (VED) estimates were assessed using random-effects and meta-regression analyses were performed for evaluating VE over time. Compared to full dose, booster dose of overall vaccines provided better protection against any and severe Omicron infections within 3 months (p < 0.001), and within 3 months or more in any, severe, and symptomatic infections (p < 0.001). From meta-regression analysis of overall vaccines, the full-dose VE against any and symptomatic Omicron infections reduced per month by 2.45% and 5.5%, respectively; whereas booster dose effectiveness against any and symptomatic Omicron infections reduced per month by 1.79% and 1.14%, respectively. The VE estimates of booster dose provide excellent protection against symptomatic infection compared to full dose. The VE estimates of Ad26.COV2.S, BNT162b2, ChAdOx1 nCov-19, and mRNA-1273 against Omicron infection are generally moderate, despite the VE estimates declining over time. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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Other

Jump to: Research, Review

6 pages, 208 KiB

Open AccessBrief Report

Safety of Interchanging the Live Attenuated MAV/06 Strain and OKA Strain Varicella Vaccines in Children

by Hyun Mi Kang, Gwanglok Kim and Young June Choe

Vaccines 2023, 11(9), 1442; https://doi.org/10.3390/vaccines11091442 - 31 Aug 2023

Viewed by 900

Abstract

Two live attenuated varicella vaccine (VZV) strains have been mainly used across the globe: MAV/06 and OKA strains. We aimed to explore the safety of interchanging the two VZV strains for primary and booster immunizations. South Korea’s vaccine adverse event reporting system (VAERS) [...] Read more.

Two live attenuated varicella vaccine (VZV) strains have been mainly used across the globe: MAV/06 and OKA strains. We aimed to explore the safety of interchanging the two VZV strains for primary and booster immunizations. South Korea’s vaccine adverse event reporting system (VAERS) was accessed and searched to find filed reports of all adverse events (AEs) following immunization with the second dose of the varicella vaccine. The electronic medical records were reviewed for all visits to the hospital following the second dose of the varicella vaccine. Of the total 406 study participants, 27.5% (n = 112) were in the MAV/06–MAV/06 group, 30.3% (n = 123) in the MAV/06–OKA, 17.5% (n = 71) in the OKA–MAV/06 group, and 24.6% (n = 100) in the OKA–OKA group. Mean age at immunization with the first dose was 1.10 (standard deviation [SD] ±0.34) years old, and second dose was 4.77 (SD ± 1.13) (p = 0.772 and 0.933, respectively). There were no filed reports of AEs following the second dose in the national VAERS. Hospital visit records showed a total of 10.3% (95% confidence interval [CI], 7.6–13.7) (n = 42) had recorded AEs following the 2nd administered dose; however, only 0.7% (95% CI, 0.2–2.4) (n = 3) were regarded as possibly vaccine related. Two patients in the MAV/06–OKA group were diagnosed with Henoch-Schonlein purpura after the second dose; however, both had also received the MMR vaccine on the same day. No safety signals associated with interchanging the MAV/06 and OKA strain live attenuated varicella vaccines were observed in this patient cohort of healthy children. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

4 pages, 189 KiB

Open AccessReply

Reply to Kapur, V. Is Pre-Exposure Prophylaxis a Cost-Effective Intervention to Avert Rabies Deaths among School-Aged Children in India? Comment on “Royal et al. A Cost-Effectiveness Analysis of Pre-Exposure Prophylaxis to Avert Rabies Deaths in School-Aged Children in India. Vaccines 2023, 11, 88”

by Abhishek Royal, Denny John, Omesh Bharti, Ritesh Tanwar, Deepak Kumar Bhagat, Retna Siwi Padmawati, Vishal Chaudhary, Reddicherla Umapathi, Pradeep Bhadola and Adi Utarini

Vaccines 2023, 11(4), 807; https://doi.org/10.3390/vaccines11040807 - 06 Apr 2023

Viewed by 1005

Abstract

Thank you so much for forwarding the critical analysis the author (VK) conducted on our recently published modelling study ‘A Cost-Effectiveness Analysis of Pre-Exposure Prophylaxis to Avert Rabies Deaths in School-Aged Children in India’ in your reputed journal [...] Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

4 pages, 186 KiB

Open AccessComment

Is Pre-Exposure Prophylaxis a Cost-Effective Intervention to Avert Rabies Deaths among School-Aged Children in India? Comment on Royal et al. A Cost-Effectiveness Analysis of Pre-Exposure Prophylaxis to Avert Rabies Deaths in School-Aged Children in India. Vaccines 2023, 11, 88

by Vivek Kapur

Vaccines 2023, 11(3), 677; https://doi.org/10.3390/vaccines11030677 - 16 Mar 2023

Cited by 2 | Viewed by 1348

Abstract

I read with interest the article “A Cost-Effectiveness Analysis of Pre-Exposure Prophylaxis to Avert Rabies Deaths in School-Aged Children in India” by Royal et al., recently published in Vaccines [...] Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

17 pages, 2142 KiB

Open AccessSystematic Review

Immunogenicity and Safety of Childhood Combination Vaccines: A Systematic Review and Meta-Analysis

by Bei Liu, Bing Cao, Chao Wang, Bingfeng Han, Tao Sun, Yudong Miao, Qingbin Lu and Fuqiang Cui

Vaccines 2022, 10(3), 472; https://doi.org/10.3390/vaccines10030472 - 18 Mar 2022

Cited by 5 | Viewed by 3529

Abstract

Background: Vaccination is considered the most effective and economical measure for controlling infectious diseases. Although combination vaccines are widely used worldwide, whether any of the combination vaccines is superior to each separate vaccine has yet to be established. This systematic review and meta-analysis [...] Read more.

Background: Vaccination is considered the most effective and economical measure for controlling infectious diseases. Although combination vaccines are widely used worldwide, whether any of the combination vaccines is superior to each separate vaccine has yet to be established. This systematic review and meta-analysis aimed to summarize the available evidence on the effectiveness and safety of combination vaccines in children. Methods: A systematic search was conducted from database inception to August 20, 2021, in MEDLINE, Embase, Cochrane, and Scopus. Published randomized clinical trials (RCTs) and open-label trials of immunogenicity and safety of combined vaccines were selected. The results of the studies were quantitatively synthesized. Results: Overall, 25 articles met the inclusion criteria and were included in the meta-analysis. The results indicated that the combined diptheria–tetanus–acellular pertussis (DTaP)–hepatitis B virus (HBV)–Haemophilus influenzae type B (Hib) vaccine group had lower levels of anti-tetanus antibodies than the combined DTaP–HBV and separate Hib vaccinations group (SMD = −0.23; 95% CI: −0.42, −0.05; p = 0.013). Meanwhile, the combined DTaP–HBV–inactivated polio virus (IPV)–Hib vaccine group had higher levels of anti-pertussis (PT) and anti-filamentous hemagglutinin (FHA) antibodies than the combined DTaP–IPV–Hib and separate HBV vaccinations group (anti-PT: SMD = 0.60; 95% CI: 0.45, 0.75; p < 0.0001; anti-FHA: SMD = 0.40; 95% CI: 0.01, 0.78; p = 0.042). The levels of anti-pertactin (PRN) antibodies were lower in the combined DTaP–IPV–Hib vaccine group than in the combined DTaP–IPV and separate Hib vaccinations group (SMD = −0.13; 95% CI: −0.27, −0.00; p = 0.047). The individuals injected with the DTaP–HBV–IPV–Hib vaccine had a lower risk of pain and swelling than those injected with the combined DTaP–HBV–IPV and separate Hib vaccines (pain: RR = 0.79; 95% CI: 0.69, 0.91; p = 0.001; swelling: RR = 0.87; 95% CI: 0.78, 0.98; p = 0.020). However, the group that received the DTaP–HBV–IPV–Hib vaccine had a higher risk of fever than the group that received DTaP–HBV–IPV and separate Hib vaccinations (RR = 1.13; 95% CI: 1.02, 1.26; p = 0.021). Conclusions: This meta-analysis suggests that the combined vaccines (DTaP–IPV–Hib, DTaP–HBV–Hib, DTaP–HBV–IPV–Hib) are safe, well-tolerated, and provide immunogenic alternatives to separate vaccines in children. The combined DTaP–HBV–IPV–Hib vaccine showed a higher incidence of fever, which was lower than the cumulative incidence of fever induced by all vaccines. Future studies should evaluate the cost-effectiveness of using combined vaccines and compare the potency of different formulations to improve routine local or national childhood immunization programs. Full article

(This article belongs to the Special Issue Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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