Research

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15 pages, 1580 KiB

Open AccessArticle

Healthcare Worker Study Cohort to Determine the Level and Durability of Cellular and Humoral Immune Responses after Two Doses of SARS-CoV-2 Vaccination

by Chiara Dentone, Daniela Fenoglio, Marta Ponzano, Matteo Cerchiaro, Tiziana Altosole, Diego Franciotta, Federica Portunato, Malgorzata Mikulska, Lucia Taramasso, Laura Magnasco, Chiara Uras, Federica Magne, Francesca Ferrera, Graziana Scavone, Alessio Signori, Antonio Vena, Valeria Visconti, Gilberto Filaci, Alessandro Sette, Alba Grifoni, Antonio Di Biagio and Matteo Bassetti Show full author list Hide full author list

Vaccines 2022, 10(11), 1784; https://doi.org/10.3390/vaccines10111784 - 24 Oct 2022

Cited by 2 | Viewed by 1661

Abstract

We prospectively studied immunological response against SARS-CoV-2 after vaccination among healthcare workers without (group A) and with previous infection (group B). The analyses were collected at T0 (before the BNT162b2), T1 (before the second dose), T2 and T6 (1 and 6 months after [...] Read more.

We prospectively studied immunological response against SARS-CoV-2 after vaccination among healthcare workers without (group A) and with previous infection (group B). The analyses were collected at T0 (before the BNT162b2), T1 (before the second dose), T2 and T6 (1 and 6 months after the second dose). For cellular immune response, the activation-induced cell marker assay was performed with CD4 and CD8 Spike peptide megapools expressed as Stimulation Index. For humoral immune response, we determined antibodies to Spike-1 and nucleocapsid protein. The linear mixed model compared specific times to T0. The CD4+ Spike response overall rate of change was significant at T1 (p = 0.038) and at T2 (p < 0.001), while decreasing at T6. For CD8+ Spike reactivity, the interaction between the time and group was significant (p = 0.0265), and the p value for group comparison was significant at the baseline (p = 0.0030) with higher SI in previously infected subjects. Overall, the anti-S Abs significantly increased from T1 to T6 compared to T0. The group B at T6 retained high anti-S titer (p < 0.001). At T6, in both groups we found a persistent humoral response and a high CD4+ T cell response able to cross recognize SARS-COV-2 variants including epsilon, even if not a circulating virus at that time. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

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9 pages, 238 KiB

Open AccessArticle

Phase I Study to Assess the Safety and Immunogenicity of an Intradermal COVID-19 DNA Vaccine Administered Using a Pyro-Drive Jet Injector in Healthy Adults

by Hironori Nakagami, Hiroki Hayashi, Jiao Sun, Yuka Yanagida, Takako Otera, Futoshi Nakagami, Shigeto Hamaguchi, Hisao Yoshida, Hideo Okuno, Shota Yoshida, Ryo Nakamaru, Serina Yokoyama, Taku Fujimoto, Kazuhiro Hongyo, Yukihiro Akeda, Ryuichi Morishita, Kazunori Tomono and Hiromi Rakugi

Vaccines 2022, 10(9), 1427; https://doi.org/10.3390/vaccines10091427 - 30 Aug 2022

Cited by 7 | Viewed by 2903

Abstract

We conducted a nonrandomized, open-label phase I study to assess the safety and immunogenicity of an intradermal coronavirus disease 2019 (COVID-19) DNA vaccine (AG0302-COVID-19) administered using a pyro-drive jet injector at Osaka University Hospital between Yanagida November 2020 and December 2021. Twenty healthy [...] Read more.

We conducted a nonrandomized, open-label phase I study to assess the safety and immunogenicity of an intradermal coronavirus disease 2019 (COVID-19) DNA vaccine (AG0302-COVID-19) administered using a pyro-drive jet injector at Osaka University Hospital between Yanagida November 2020 and December 2021. Twenty healthy volunteers, male or female, were enrolled in the low-dose (0.2 mg) or high-dose (0.4 mg) groups and administered AG0302-COVID19 twice at a 2-week interval. There were no adverse events that led to discontinuation of the study drug vaccination schedule. A serious adverse event (disc protrusion) was reported in one patient in the high-dose group, but the individual recovered, and the adverse event was not causally related to the study drug. In the analysis of the humoral immune response, the geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody was low in both the low-dose and high-dose groups (246.2 (95% CI 176.2 to 344.1, 348.2 (95% CI 181.3 to 668.9)) at the 8 weeks after first vaccination. Regarding the analysis of the cellular immune, the number of IFN-γ-producing cells responsive to the SARS-CoV-2 spike glycoprotein increased with individual differences after the first dose and was sustained for several months. Overall, no notable safety issues were observed with the intradermal inoculations of AG0302-COVID19. Regarding immunogenicity, a cellular immune response was observed in some subjects after AG0302-COVID19 intradermal inoculation, but no significant antibody production was observed. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

6 pages, 230 KiB

Open AccessCommunication

Early Clinical Experience with Molnupiravir for Mild to Moderate Breakthrough COVID-19 among Fully Vaccinated Patients at Risk for Disease Progression

by Antonio Vena, Luca Traman, Martina Bavastro, Alessandro Limongelli, Chiara Dentone, Federica Magnè, Daniele Roberto Giacobbe, Malgorzata Mikulska, Lucia Taramasso, Antonio Di Biagio and Matteo Bassetti

Vaccines 2022, 10(7), 1141; https://doi.org/10.3390/vaccines10071141 - 18 Jul 2022

Cited by 10 | Viewed by 2110

Abstract

Information on the efficacy and safety of molnupiravir in daily clinical practice is very scarce. We aimed to describe the clinical characteristics and outcomes of fully vaccinated patients with mild to moderate breakthrough COVID-19 treated with molnupiravir between January 2022 and February 2022. [...] Read more.

Information on the efficacy and safety of molnupiravir in daily clinical practice is very scarce. We aimed to describe the clinical characteristics and outcomes of fully vaccinated patients with mild to moderate breakthrough COVID-19 treated with molnupiravir between January 2022 and February 2022. Overall, 145 patients were enrolled. Their median age was 71.0 years, and 60.7% were males. The most common underlying condition was a severe cardiovascular disease (37.2%), followed by primary or acquired immunodeficiency (22.8%), and oncological/onco-hematological disease in the active phase (22.1%). At 30 days after breakthrough COVID-19 diagnosis, only 4 out of 145 patients (2.7%) required hospital admission. No patients developed severe COVID-19, were admitted to the ICU, or died during the follow-up period. Adverse events, mild in intensity, occurred in 2 patients (1.4%). Our results support the current evidence establishing positive clinical and safety outcomes of molnupiravir in fully vaccinated patients with mild or moderate breakthrough COVID-19. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

10 pages, 585 KiB

Open AccessArticle

Increasing Uptake of COVID-19 Vaccination and Reducing Health Inequalities in Patients on Renal Replacement Therapy—Experience from a Single Tertiary Centre

by Dimitrios Poulikakos, Rajkumar Chinnadurai, Saira Anwar, Amnah Ahmed, Chukwuma Chukwu, Jayne Moore, Emma Hayes, Julie Gorton, David Lewis, Rosie Donne, Elizabeth Lamerton, Rachel Middleton and Edmond O’Riordan

Vaccines 2022, 10(6), 939; https://doi.org/10.3390/vaccines10060939 - 13 Jun 2022

Cited by 1 | Viewed by 2099

Abstract

Background: COVID-19 vaccination has changed the landscape of the COVID-19 pandemic; however, decreased uptake due to vaccine hesitancy has been observed, particularly in patients from minority ethnic backgrounds and socially deprived areas. These patient characteristics are common in patients on Renal Replacement Therapy [...] Read more.

Background: COVID-19 vaccination has changed the landscape of the COVID-19 pandemic; however, decreased uptake due to vaccine hesitancy has been observed, particularly in patients from minority ethnic backgrounds and socially deprived areas. These patient characteristics are common in patients on Renal Replacement Therapy (RRT), a population at extremely high risk of developing serious illness from COVID-19 and who would thus benefit the most from the vaccination programme. We designed a bespoke COVID-19 vaccination programme for our RRT population with the aim of decreasing health inequalities and increasing vaccination uptake. Methods: Key interventions included addressing vaccine hesitancy by deploying the respective clinical teams as trusted messengers, prompt eligible patient identification and notification, the deployment of resources to optimise vaccine administration in a manner convenient to patients, and the timely collection and analysis of local safety and efficacy data. First, COVID-19 vaccination data in relation to ethnicity and social deprivation in our RRT population, measured by the multiple deprivation index, were analysed and compared to uptake data in the total regional adult clinically extremely vulnerable (CEV) population in Greater Manchester (GM). Univariate logistic regression analysis was used to explore the factors associated with not receiving a vaccine. Results: Out of 1156 RRT patients included in this analysis, 96.7% received the first dose of the vaccination compared to 93% in the cohort of CEV patients in the GM. Age, gender, ethnicity, and a lower index of multiple deprivation were not identified as significant risk factors for poor first dose vaccine uptake in our cohort. Vaccine uptake in Asian and Black RRT patients was 94.9% and 92.3%, respectively, compared to 93% and 76.2% for the same ethnic groups in the reference CEV GM. Vaccine uptake was 96.1% for RRT patients in the lowest quartile of the multiple deprivation index, compared to 90.5% in the GM reference population. Conclusion: Bespoke COVID-19 vaccination programmes based on local clinical teams as trusted messengers can improve negative attitudes towards vaccination and reduce health inequalities. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

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16 pages, 670 KiB

Open AccessArticle

Balancing Benefits and Harms of COVID-19 Vaccines: Lessons from the Ongoing Mass Vaccination Campaign in Lombardy, Italy

by Giovanni Corrao, Federico Rea, Matteo Franchi, Danilo Cereda, Antonio Barone, Catia Rosanna Borriello, Giulia Petra Della Valle, Michele Ercolanoni, Jose Jara, Giuseppe Preziosi, Manuel Maffeo, Francesco Mazziotta, Elisabetta Pierini, Francesco Lecis, Pierfrancesco Sanchirico, Francesco Vignali, Olivia Leoni, Ida Fortino, Massimo Galli, Giovanni Pavesi and Guido Bertolaso Show full author list Hide full author list

Vaccines 2022, 10(4), 623; https://doi.org/10.3390/vaccines10040623 - 15 Apr 2022

Cited by 2 | Viewed by 2785

Abstract

Background. Limited evidence exists on the balance between the benefits and harms of the COVID-19 vaccines. The aim of this study is to compare the benefits and safety of mRNA-based (Pfizer-BioNTech and Moderna) and adenovirus-vectored (Oxford-AstraZeneca) vaccines in subpopulations defined by age [...] Read more.

Background. Limited evidence exists on the balance between the benefits and harms of the COVID-19 vaccines. The aim of this study is to compare the benefits and safety of mRNA-based (Pfizer-BioNTech and Moderna) and adenovirus-vectored (Oxford-AstraZeneca) vaccines in subpopulations defined by age and sex. Methods. All citizens who are newly vaccinated from 27 December 2020 to 3 May 2021 are matched to unvaccinated controls according to age, sex, and vaccination date. Study outcomes include the events that are expected to be avoided by vaccination (i.e., hospitalization and death from COVID-19) and those that might be increased after vaccine inoculation (i.e., venous thromboembolism). The incidence rate ratios (IRR) of vaccinated and unvaccinated citizens are separately estimated within strata of sex, age category and vaccine type. When suitable, number needed to treat (NNT) and number needed to harm (NNH) are calculated to evaluate the balance between the benefits and harm of vaccines within each sex and age category. Results. In total, 2,351,883 citizens are included because they received at least one dose of vaccine (755,557 Oxford-AstraZeneca and 1,596,326 Pfizer/Moderna). A reduced incidence of COVID-19-related outcomes is observed with a lowered incidence rate ranging from 55% to 89% and NNT values ranging from 296 to 3977. Evidence of an augmented incidence of harm-related outcomes is observed only for women aged <50 years within 28 days after Oxford-AstraZeneca (being the corresponding adjusted IRR of 2.4, 95% CI 1.1–5.6, and NNH value of 23,207, 95% CI 10,274–89,707). Conclusions. A favourable balance between benefits and harms is observed in the current study, even among younger women who received Oxford-AstraZeneca. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

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11 pages, 2156 KiB

Open AccessArticle

Cognition and Behavior of COVID-19 Vaccination Based on the Health Belief Model: A Cross-Sectional Study

by Zemin Cai, Wei Hu, Shukai Zheng, Xilin Wen and Kusheng Wu

Vaccines 2022, 10(4), 544; https://doi.org/10.3390/vaccines10040544 - 01 Apr 2022

Cited by 9 | Viewed by 2567

Abstract

Background: Vaccination is the most effective method for the prevention of COVID-19. However, willingness to be vaccinated is not consistent. This study aimed to explore vaccine cognition, risk perception, and health behavior of COVID-19 in China. Methods: A cross-sectional survey was performed in [...] Read more.

Background: Vaccination is the most effective method for the prevention of COVID-19. However, willingness to be vaccinated is not consistent. This study aimed to explore vaccine cognition, risk perception, and health behavior of COVID-19 in China. Methods: A cross-sectional survey was performed in Guangdong province, China, including demographic characteristics, health status and preventive behaviors, cognition of COVID-19 vaccination, and the health belief model (HBM). Results: A total of 1640 participants were recruited. The main access to information about COVID-19 and vaccination as through official news and broadcasts (67.3%), social network software (58.7%), and professional popularization (46.2%). The precautions taken were wearing a mask (67.0%) and avoiding gathering together (71.3%). COVID-19 vaccination acceptability was different among different age groups and educational levels (p < 0.001). The major reasons for accepting vaccination included that it was an effective way to prevent COVID-19 (61.8%) and that it was required by working units/schools (51.1%). The fitting effect indexes of the (HBM) Model 2 showed better fitting than those of Model 1. In Model 2, perceived benefits (OR = 3.13, 95% CI: 1.79–5.47), cues to action (OR = 2.23, 95% CI: 1.60–3.11), and different occupations (OR = 1.13, 95% CI: 1.04–1.23) were positively correlated with vaccine acceptance; while perceived susceptibility (OR = 0.47, 95% CI: 0.30–0.74) and perceived barriers (OR = 0.44, 95% CI: 0.29–0.69) were negative factors associated with vaccine acceptance. Conclusion: Different sociodemographic characteristics lead to differences in acceptance of vaccination, and the publicity and credibility of government play an indispensable role in epidemic control. The establishment of the HBM further predicted that perceived susceptibility to COVID-19, benefits of vaccination, barriers of cognition, and cue to action were the influencing factors of intention and health behaviors. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

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8 pages, 248 KiB

Open AccessArticle

Childhood Immunisation Coverage during the COVID-19 Epidemic in Italy

by Michela Sabbatucci, Anna Odone, Carlo Signorelli, Andrea Siddu, Andrea Silenzi, Francesco Paolo Maraglino and Giovanni Rezza

Vaccines 2022, 10(1), 120; https://doi.org/10.3390/vaccines10010120 - 14 Jan 2022

Cited by 19 | Viewed by 3595

Abstract

The COVID-19 pandemic has affected national healthcare systems worldwide, with around 282 million cumulative confirmed cases reported in over 220 countries and territories as of the end of 2021. The Italian National Health System was heavily affected, with detrimental impacts on preventive service [...] Read more.

The COVID-19 pandemic has affected national healthcare systems worldwide, with around 282 million cumulative confirmed cases reported in over 220 countries and territories as of the end of 2021. The Italian National Health System was heavily affected, with detrimental impacts on preventive service delivery. Routine vaccination services were disrupted across the country during the first months of the pandemic, and both access to and demand for vaccines have decreased during the pandemic. In many cases, parents preferred to postpone scheduled appointments for routine paediatric vaccinations because of stay-at-home orders or fear of COVID-19 infection when accessing care. The objective of the current study was to assess the routine childhood vaccine coverage (VC) rates during the COVID-19 epidemic in Italy. We compared 2020 and 2019 VC by age group and vaccine type. The Italian Ministry of Health collected anonymised and aggregated immunisation national data through the local health authorities (LHAs). Results were considered statistically significant at a two-tailed p-value ≤ 0.05. VC rates for mandatory vaccinations decreased in 2020 compared to 2019 (range of VC rate decrease: −1% to −2.7%), while chicken pox increased (+2.2%) in 7-year-old children. Recommended vaccinations were moderately affected (range of VC rate decrease in 2020 vs. 2019: −1.4% to −8.5%), with the exception of anti-HPV in males, Men ACWY, and anti-rotavirus vaccination (VC increase 2020 vs. 2019: +1.8%, +4.7% and +9.4%, respectively). In the COVID-19 era, the implementation of coherent, transparent, and effective communication campaigns and educational programs on safe childhood vaccinations, together with the increase in the number of healthcare staff employed, is essential to support strategies to reinforce vaccination confidence and behaviour, thus avoiding health threats due to VPD during and beyond COVID-19 times. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

12 pages, 1014 KiB

Open AccessArticle

Rapid Weight Loss, Central Obesity Improvement and Blood Glucose Reduction Are Associated with a Stronger Adaptive Immune Response Following COVID-19 mRNA Vaccine

by Mikiko Watanabe, Angela Balena, Davide Masi, Rossella Tozzi, Renata Risi, Alessandra Caputi, Rebecca Rossetti, Maria Elena Spoltore, Filippo Biagi, Emanuela Anastasi, Antonio Angeloni, Stefania Mariani, Carla Lubrano, Dario Tuccinardi and Lucio Gnessi

Vaccines 2022, 10(1), 79; https://doi.org/10.3390/vaccines10010079 - 05 Jan 2022

Cited by 26 | Viewed by 6056

Abstract

Obesity is associated with a poor COVID-19 prognosis, and it seems associated with reduced humoral response to vaccination. Public health campaigns have advocated for weight loss in subjects with obesity, hoping to eliminate this risk. However, no evidence proves that weight loss leads [...] Read more.

Obesity is associated with a poor COVID-19 prognosis, and it seems associated with reduced humoral response to vaccination. Public health campaigns have advocated for weight loss in subjects with obesity, hoping to eliminate this risk. However, no evidence proves that weight loss leads to a better prognosis or a stronger immune response to vaccination. We aimed to investigate the impact of rapid weight loss on the adaptive immune response in subjects with morbid obesity. Twenty-one patients followed a hypocaloric, very-low-carbohydrate diet one week before to one week after the two mRNA vaccine doses. The diet’s safety and efficacy were assessed, and the adaptive humoral (anti-SARS CoV-2 S antibodies, Abs) and cell-mediated responses (IFNγ secretion on stimulation with two different SARS CoV-2 peptide mixes, IFNγ-1 and IFNγ-2) were evaluated. The patients lost ~10% of their body weight with metabolic improvement. A high baseline BMI correlated with a poor immune response (R −0.558, p = 0.013 for IFNγ-1; R −0.581, p = 0.009 for IFNγ-2; R −0.512, p = 0.018 for Abs). Furthermore, there was a correlation between weight loss and higher IFNγ-2 (R 0.471, p = 0.042), and between blood glucose reduction and higher IFNγ-1 (R 0.534, p = 0.019), maintained after weight loss and waist circumference reduction adjustment. Urate reduction correlated with higher Abs (R 0.552, p = 0.033). In conclusion, obesity is associated with a reduced adaptive response to a COVID-19 mRNA vaccine, and weight loss and metabolic improvement may reverse the effect. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

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Review

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10 pages, 266 KiB

Open AccessReview

SARS-CoV-2 Vaccination in Solid-Organ Transplant Recipients

by Maddalena Peghin, Elena Graziano and Paolo Antonio Grossi

Vaccines 2022, 10(9), 1430; https://doi.org/10.3390/vaccines10091430 - 30 Aug 2022

Cited by 6 | Viewed by 1387

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has posed significant global challenges for solid organ transplant (SOT) recipients. Mortality rates of COVID-19 in this patient population remain high, despite new available therapeutic options and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination. Priority access [...] Read more.

The coronavirus disease 2019 (COVID-19) pandemic has posed significant global challenges for solid organ transplant (SOT) recipients. Mortality rates of COVID-19 in this patient population remain high, despite new available therapeutic options and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination. Priority access to SARS-CoV-2 vaccination for waitlisted candidates and for SOT patients and their family members is recommended since the advantage from vaccination reduces the risk of COVID-19-related complications. However, immunogenicity and efficacy of COVID-19 vaccines are lower in waitlisted candidates and SOT recipients than in the general population. Routine systematic assessment of humoral and cellular immune responses after SARS-CoV-2 vaccination is controversial, although highly recommended for investigation and improvement of knowledge. SOT recipients should continue to adhere to preventive protective measures despite vaccination and may undergo passive antibody prophylaxis. This article seeks to provide an update on SARS-CoV-2 vaccination and preventive measures in SOT recipients based on existing literature and international guidelines. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

16 pages, 711 KiB

Open AccessReview

The Effect of Smoking on Humoral Response to COVID-19 Vaccines: A Systematic Review of Epidemiological Studies

by Pietro Ferrara, Vincenza Gianfredi, Venera Tomaselli and Riccardo Polosa

Vaccines 2022, 10(2), 303; https://doi.org/10.3390/vaccines10020303 - 16 Feb 2022

Cited by 52 | Viewed by 6432

Abstract

While the role of active smoking on response to vaccines is yet to be fully understood, some real-world studies have outlined a possible link between smoking and humoral response to COVID-19 vaccines. Thus, the present rapid systematic review aimed at summarizing the current [...] Read more.

While the role of active smoking on response to vaccines is yet to be fully understood, some real-world studies have outlined a possible link between smoking and humoral response to COVID-19 vaccines. Thus, the present rapid systematic review aimed at summarizing the current epidemiological evidence on this association. Following PRISMA and WHO guidelines on rapid systematic reviews, we systematically reviewed published literature on this topic and discussed the findings according to the aim of analysing smoking and its impact on humoral response to COVID-19 postvaccination antibody titres. The search strategy yielded a total of 23 articles. The sample size amongst the studies ranged between 74 and 3475 participants (median, 360), with the proportion of smokers being between 4.2% and 40.8% (median, 26.0%). The studies included in this review analysis investigated the dynamics of antibody response to different type of COVID-19 vaccines. In 17 out of 23 studies, current smokers showed much lower antibody titres or more rapid lowering of the vaccine-induced IgG compared with nonsmokers. This rapid systematic review indicates that active smoking negatively impacts humoral response to COVID-19 vaccines, although the pathophysiologic mechanisms for this association have not been entirely suggested. The results advocate targeted policies to promote tailored health promotion initiatives, which can increase risk perception and ensure appropriate protection measures to be taken to avoid the health consequences of COVID-19 in smokers. Full article

(This article belongs to the Special Issue COVID-19 Vaccines: The Way Back to Normal Life Is Now Marked)

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