Research

15 pages, 4395 KiB

Open AccessArticle

Long-Term Cross Immune Response in Mice following Heterologous Prime-Boost COVID-19 Vaccination with Full-Length Spike mRNA and Recombinant S1 Protein

by Dandan Li, Heng Zhao, Yun Liao, Guorun Jiang, Pingfang Cui, Ying Zhang, Li Yu, Shengtao Fan, Hangwen Li and Qihan Li

Vaccines 2023, 11(5), 963; https://doi.org/10.3390/vaccines11050963 - 09 May 2023

Cited by 1 | Viewed by 1714

Abstract

(1) Background: As the COVID-19 pandemic enters its fourth year, it continues to cause significant morbidity and mortality worldwide. Although various vaccines have been approved and the use of homologous or heterologous boost doses is widely promoted, the impact of vaccine antigen basis, [...] Read more.

(1) Background: As the COVID-19 pandemic enters its fourth year, it continues to cause significant morbidity and mortality worldwide. Although various vaccines have been approved and the use of homologous or heterologous boost doses is widely promoted, the impact of vaccine antigen basis, forms, dosages, and administration routes on the duration and spectrum of vaccine-induced immunity against variants remains incompletely understood. (2) Methods: In this study, we investigated the effects of combining a full-length spike mRNA vaccine with a recombinant S1 protein vaccine, using intradermal/intramuscular, homologous/heterologous, and high/low dosage immunization strategies. (3) Results: Over a period of seven months, vaccination with a mutant recombinant S1 protein vaccine based on the full-length spike mRNA vaccine maintained a broadly stable humoral immunity against the wild-type strain, a partially attenuated but broader-spectrum immunity against variant strains, and a comparable level of cellular immunity across all tested strains. Furthermore, intradermal vaccination enhanced the heterologous boosting of the protein vaccine based on the mRNA vaccine. (4) Conclusions: This study provides valuable insights into optimizing vaccination strategies to address the ongoing challenges posed by emerging SARS-CoV-2 variants. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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12 pages, 4129 KiB

Open AccessArticle

The Fourth Dose of mRNA COVID-19 Vaccine Following 12 Different Three-Dose Regimens: Safety and Immunogenicity to Omicron BA.4/BA.5

by Sitthichai Kanokudom, Jira Chansaenroj, Nungruthai Suntronwong, Suvichada Assawakosri, Ritthideach Yorsaeng, Pornjarim Nilyanimit, Ratchadawan Aeemjinda, Nongkanok Khanarat, Preeyaporn Vichaiwattana, Sirapa Klinfueng, Thanunrat Thongmee, Donchida Srimuan, Thaksaporn Thatsanathorn, Natthinee Sudhinaraset, Nasamon Wanlapakorn, Sittisak Honsawek and Yong Poovorawan

Vaccines 2023, 11(3), 570; https://doi.org/10.3390/vaccines11030570 - 01 Mar 2023

Cited by 3 | Viewed by 1541

Abstract

The aim of this study is to investigate the reactogenicity and immunogenicity of the fourth dose using monovalent mRNA vaccines after different three-dose regimens and to compare the 30 µg BNT162b2 and 50 µg mRNA-1273 vaccines. This prospective cohort study was conducted between [...] Read more.

The aim of this study is to investigate the reactogenicity and immunogenicity of the fourth dose using monovalent mRNA vaccines after different three-dose regimens and to compare the 30 µg BNT162b2 and 50 µg mRNA-1273 vaccines. This prospective cohort study was conducted between June and October 2022. The self-recorded reactogenicity was evaluated on the subsequent 7 days after a fourth dose. The binding and neutralizing activity of antibodies against the Omicron BA.4/5 variants were determined. Overall, 292 healthy adults were enrolled and received BNT162b2 or mRNA-1273. Reactogenicity was mild to moderate and well tolerated after a few days. Sixty-five individuals were excluded. Thus, 227 eligible individuals received a fourth booster dose of BNT162b2 (n = 109) and mRNA-1273 (n = 118). Most participants, regardless of the type of previous three-dose regimens, elicited a significantly high level of binding antibodies and neutralizing activity against Omicron BA.4/5 28 days after a fourth dose. The neutralizing activity against Omicron BA.4/5 between the BNT162b2 (82.8%) and mRNA-1273 (84.2%) groups was comparable with a median ratio of 1.02. This study found that the BNT162b2 and mRNA-1273 vaccines can be used as a fourth booster dose for individuals who were previously immunized with any prior three-dose mix-and-match COVID-19 vaccine regimens. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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12 pages, 1175 KiB

Open AccessArticle

Effectiveness of Inactivated Vaccine against SARS-CoV-2 Delta Variant Infection in Xiamen, China—A Test-Negative Case-Control Study

by Tingjuan He, Meixia Wang, Hongfei Mi, Liansheng Xu, Wenkui Lu, Xue Ouyang, Zhinan Guo and Chenghao Su

Vaccines 2023, 11(3), 532; https://doi.org/10.3390/vaccines11030532 - 23 Feb 2023

Viewed by 1233

Abstract

Objective: Vaccine effectiveness can measure herd immunity, but the effectiveness of inactivated vaccines in Xiamen remains unclear. Our study was designed to understand the herd immunity of the COVID-19 inactivated vaccine against the SARA-CoV-2 Delta variant in the real world of Xiamen. Methods: [...] Read more.

Objective: Vaccine effectiveness can measure herd immunity, but the effectiveness of inactivated vaccines in Xiamen remains unclear. Our study was designed to understand the herd immunity of the COVID-19 inactivated vaccine against the SARA-CoV-2 Delta variant in the real world of Xiamen. Methods: We carried out a test-negative case-control study to explore the vaccine’s effectiveness. Participants aged over 12 years were recruited. A logistic regression was used to estimate the odds ratio (OR) of the vaccine among cases and controls. Results: This outbreak began with factory transmission clusters, and spread to families and communities during the incubation period. Sixty percent of cases were confirmed in a quarantine site. A huge mass of confirmed cases (94.49%) was identified within three days, and nearly half of them had a low Ct value. Following an adjustment for age and sex, a single dose of inactivated SARS-CoV-2 vaccine yielded the vaccine effectiveness (VE) of the overall case, of 57.01% (95% CI: −91.44~86.39%), the fully VE was 65.72% (95% CI: −48.69~88.63%) against COVID-19, 59.45% against moderate COVID-19 and 38.48% against severe COVID-19, respectively. The VE of fully vaccinated individuals was significantly higher in females than in males (73.99% vs. 46.26%). The VE among participants aged 19~40 and 41~61 years was 78.75% and 66.33%, respectively, which exceeds the WHO’s minimal threshold. Nevertheless, the VE in people under 18 and over 60 years was not observed because of the small sample size. Conclusions: The single-dose vaccine had limited effectiveness in preventing infection of the Delta variant. The two doses of inactivated vaccine could effectively prevent infection, and clinical mild, moderate, and severe illness caused by the SARS-CoV-2 Delta variant in people aged 18–60 years in the real world. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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14 pages, 2747 KiB

Open AccessArticle

COVID-19 mRNA Vaccine Tolerance and Immunogenicity in Hematopoietic Stem Cell Transplantation Recipients Aged 5–11 Years Old–Non-Randomized Clinical Trial

by Agnieszka Matkowska-Kocjan, Joanna Owoc-Lempach, Kamila Ludwikowska, Filip Szenborn, Natalia Moskwa, Katarzyna Kurek, Krzysztof Kałwak, Leszek Szenborn and Marek Ussowicz

Vaccines 2023, 11(1), 195; https://doi.org/10.3390/vaccines11010195 - 16 Jan 2023

Cited by 4 | Viewed by 2139

Abstract

The SARS-CoV-2 pandemic had a devastating impact on the world’s population in the years 2020–2022. The rapid development of vaccines enabled a reduction in the mortality and morbidity of COVID-19, but there are limited data about their effects on immunocompromised children. The aim [...] Read more.

The SARS-CoV-2 pandemic had a devastating impact on the world’s population in the years 2020–2022. The rapid development of vaccines enabled a reduction in the mortality and morbidity of COVID-19, but there are limited data about their effects on immunocompromised children. The aim of this prospective study was to evaluate the safety and efficacy of the mRNA BNT162b2 (Pfizer/Biontech) vaccine in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Material and methods: Two cohorts of 34 children after allo-HSCT and 35 healthy children aged 5–11 years were vaccinated with two doses of the mRNA BNT162b2 (10 µg) vaccine. All children were evaluated for adverse effects with electronic surveys and the immunogenicity of the vaccine was assessed with anti-SARS-CoV-2 IgG titer measurements. Results: All reported adverse events (AEs) were classified as mild. The most common AE was pain at the injection site. All the other AEs (both local and systemic) were rarely reported (<15% patients). Both groups showed a similar response in anti-SARS-CoV-2 IgG production. Patients after allo-HSCT that were undergoing immunosuppressive treatment presented a poorer immunological response than patients off of treatment. Time since HSCT, patient age, lymphocyte count, and total IgG concentration did not correlate with initial/post-vaccination anti-SARS-CoV-2 IgG titers. Most patients who were eligible for a third dose of the vaccine had an excellent humoral response observed after two vaccine doses. Conclusions: The COVID-19 mRNA BNT162b2 vaccine is very well tolerated and highly immunogenic in 5–11-year-old children after HSCT. Children >2 years of age after HSCT who did not receive immunosuppressive treatment presented excellent antibody production after two doses of the vaccine, but children on immunosuppression may require a more intense vaccination schedule. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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14 pages, 2137 KiB

Open AccessArticle

S Trimer Derived from SARS-CoV-2 B.1.351 and B.1.618 Induced Effective Immune Response against Multiple SARS-CoV-2 Variants

by Hongye Wang, Zengshuai Wang, Liang Ma, Xiaoyong Zhu, Bingxiang Li, Yuhang Huang, Jingwen Li, Ming Sun, Li Shi and Yufeng Yao

Vaccines 2023, 11(1), 193; https://doi.org/10.3390/vaccines11010193 - 16 Jan 2023

Cited by 2 | Viewed by 1535

Abstract

The spread of SARS-CoV-2 and its variants leads to a heavy burden on healthcare and the global economy, highlighting the need for developing vaccines that induce broad immunity against coronavirus. Here, we explored the immunogenicity of monovalent or bivalent spike (S) trimer subunit [...] Read more.

The spread of SARS-CoV-2 and its variants leads to a heavy burden on healthcare and the global economy, highlighting the need for developing vaccines that induce broad immunity against coronavirus. Here, we explored the immunogenicity of monovalent or bivalent spike (S) trimer subunit vaccines derived from SARS-CoV-2 B.1.351 (S1-2P) or/and B.1. 618 (S2-2P) in Balb/c mice. Both S1-2P and S2-2P elicited anti-spike antibody responses, and alum adjuvant induced higher levels of antibodies than Addavax adjuvant. The dose responses of the vaccines on immunogenicity were evaluated in vivo. A low dose of 5 μg monovalent recombinant protein or 2.5 μg bivalent vaccine triggered high-titer antibodies that showed cross-activity to Beta, Delta, and Gamma RBD in mice. The third immunization dose could boost (1.1 to 40.6 times) high levels of cross-binding antibodies and elicit high titers of neutralizing antibodies (64 to 1024) prototype, Beta, Delta, and Omicron variants. Furthermore, the vaccines were able to provoke a Th1-biased cellular immune response. Significantly, at the same antigen dose, S1-2P immune sera induced stronger broadly neutralizing antibodies against prototype, Beta, Delta, and Omicron variants compared to that induced by S2-2P. At the same time, the low dose of bivalent vaccine containing S2-2P and S1-2P (2.5 μg for each antigen) significantly improved the cross-neutralizing antibody responses. In conclusion, our results showed that monovalent S1-2P subunit vaccine or bivalent vaccine (S1-2P and S2-2P) induced potent humoral and cellular responses against multiple SARS-CoV-2 variants and provided valuable information for the development of recombinant protein-based SARS-CoV-2 vaccines that protect against emerging SARS-CoV-2 variants. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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14 pages, 4262 KiB

Open AccessArticle

Evaluation of Immunogenicity and Clinical Protection of SARS-CoV-2 S1 and N Antigens in Syrian Golden Hamster

by Zhenye Niu, Xueqi Li, Yang Gao, Lichun Wang, Shengtao Fan, Xingli Xu, Guorun Jiang, Pingfang Cui, Dandan Li, Yun Liao, Li Yu, Heng Zhao, Ying Zhang and Qihan Li

Vaccines 2022, 10(12), 1996; https://doi.org/10.3390/vaccines10121996 - 24 Nov 2022

Cited by 1 | Viewed by 1311

Abstract

The novel coronavirus (SARS-CoV-2) epidemic continues to be a global public crisis affecting human health. Many research groups are developing different types of vaccines to suppress the spread of SARS-CoV-2, and some vaccines have entered phase III clinical trials and have been rapidly [...] Read more.

The novel coronavirus (SARS-CoV-2) epidemic continues to be a global public crisis affecting human health. Many research groups are developing different types of vaccines to suppress the spread of SARS-CoV-2, and some vaccines have entered phase III clinical trials and have been rapidly implemented. Whether multiple antigen matches are necessary to induce a better immune response remains unclear. To address this question, this study tested the immunogenicity and protective effects of a SARS-CoV-2 recombinant S and N peptide vaccine in the Syrian golden hamster model. This experiment was based on two immunization methods: intradermal and intramuscular administration. Immunized hamsters were challenged with live SARS-CoV-2 14 days after booster immunization. Clinical symptoms were observed daily, and the antibody titer and viral load in each tissue were detected. The results showed that immunization of golden hamsters with the SARS-CoV-2 structural protein S alone or in combination with the N protein through different routes induced antibody responses, whereas immunization with the N protein alone did not. However, although the immunized hamsters exhibited partial alleviation of clinical symptoms when challenged with the virus, neither vaccine effectively inhibited the proliferation and replication of the challenging virus. In addition, the pathological damage in the immunized hamsters was similar to that in the control hamsters. Interestingly, the neutralizing antibody levels of all groups including immunized and nonimmunized animals increased significantly after viral challenge. In conclusion, the immune response induced by the experimental S and N polypeptide vaccines had no significant ability to prevent viral infection and pathogenicity in golden hamsters. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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Review

Jump to: Research, Other

15 pages, 1185 KiB

Open AccessReview

Nucleic Acid Vaccines against SARS-CoV-2

by Ying Liu and Qing Ye

Vaccines 2022, 10(11), 1849; https://doi.org/10.3390/vaccines10111849 - 31 Oct 2022

Cited by 10 | Viewed by 2372

Abstract

The coronavirus disease 2019 (COVID-19) has spread worldwide and imposed a substantial burden on human health, the environment, and socioeconomic development, which has also accelerated the process of nucleic acid vaccine development and licensure. Nucleic acid vaccines are viral genetic sequence-based vaccines and [...] Read more.

The coronavirus disease 2019 (COVID-19) has spread worldwide and imposed a substantial burden on human health, the environment, and socioeconomic development, which has also accelerated the process of nucleic acid vaccine development and licensure. Nucleic acid vaccines are viral genetic sequence-based vaccines and third-generation vaccines after whole virus vaccines and recombinant subunit vaccines, including DNA vaccines and RNA vaccines. They have many unique advantages, but there are many aspects that require optimization. Therefore, the purpose of this review is to discuss the research and development processes of nucleic acid vaccines, summarize the advantages and shortcomings, and propose further optimization strategies by taking COVID-19 vaccines as an example. Hopefully, this work can make a modest contribution in promoting the construction of emergency nucleic acid vaccine platforms and in avoiding the reemergence of similar public health emergencies. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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Other

Jump to: Research, Review

12 pages, 618 KiB

Open AccessSystematic Review

Association between Overweight/Obesity and the Safety and Efficacy of COVID-19 Vaccination: A Systematic Review

by Cangcang Fu, Nan Lin, Jihua Zhu and Qing Ye

Vaccines 2023, 11(5), 996; https://doi.org/10.3390/vaccines11050996 - 17 May 2023

Cited by 3 | Viewed by 1840

Abstract

Objective: The objective of this study was to appraise the interrelation between overweight/obesity and the safety and efficacy of COVID-19 vaccination by synthesizing the currently available evidence. Methods: A systematic review of published studies on the safety and efficacy of the COVID-19 vaccine [...] Read more.

Objective: The objective of this study was to appraise the interrelation between overweight/obesity and the safety and efficacy of COVID-19 vaccination by synthesizing the currently available evidence. Methods: A systematic review of published studies on the safety and efficacy of the COVID-19 vaccine in people who were overweight or obese was conducted. Databases including Embase, Medline Epub (Ovid), PsychInfo (Ovid), Web of Science, PubMed, CINAHL, and Google Scholar were searched to identify relevant studies. The databases of the Centers for Disease Control (CDC) and World Health Organization (WHO) were also searched for relevant unpublished and gray literature. Results: Fifteen studies were included in the review. All the included studies used observational study designs; there were ten cohort studies and five cross-sectional studies. The sample size of these studies ranged from 21 to 9,171,524. Thirteen studies reported using BNT162b2 (Pfizer-BioNTech, USA), four reported using ChAdOx-nCov19 (AstraZeneca, U.K), two were reported using CoronaVac (Sinovac, China), and two were reported using mRNA1273 (Moderna, USA). The efficacy and safety of COVID-19 vaccines have been extensively studied in individuals with overweight/obesity. Most studies have shown that the humoral response decreases with increasing BMI. The available evidence does not conclusively indicate that these vaccines are generally safe in this population. Conclusion: While the efficacy of the COVID-19 vaccine may be less than ideal in people who are overweight or obese, it does not mean that obese people should not be vaccinated, as the vaccine can still provide some protection. There is a lack of evidence for conclusions to be drawn about the safety of the vaccine in the population. This study calls on health professionals, policymakers, caregivers, and all other stakeholders to focus on monitoring the possible adverse effects of injections in overweight/obese people. Full article

(This article belongs to the Special Issue Safety and Efficacy of COVID-19 Vaccine)

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