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Vaccine against COVID-19: Current State of the Art and Future Perspectives

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A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Infectious Diseases".

Deadline for manuscript submissions: closed (20 July 2023) | Viewed by 14971

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Special Issue Editor

Prof. Dr. Fengcai Zhu

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Guest Editor

Jiangsu Provincial Center for Disease Prevention and Control, Nanjing 210009, China
Interests: vaccine; clinical study; precision immunization; public health

Special Issue Information

Dear Colleagues,

Although COVID-19 vaccines have been extensively used around the world, millions of cases are still diagnosed every day, contributing to the decreased effectiveness of the vaccine and strain variations. Therefore, it is still imperative to formulate a scientific immunization strategy based on the current COVID-19 vaccines and design and develop the next generation of COVID-19 vaccines. A thorough evaluation of how different COVID-19 vaccines were developed, regardless of whether the vaccines themselves were successes or failures, is valuable from a research point of view because it can help toward:
(1) The continued scientific, normative, and comprehensive clinical evaluation of COVID-19 vaccines with antigens originating from wild strains as well as variant strains against VOC;
(2) The development of a safe and effective heterologous prime-boost strategy which may to some degree draw on the strengths of different technology platforms and induce a rich immune response (humoral, cellular and mucosal immunity);
(3) A deeper understanding of the importance of new adjuvants and analysis of their synergistic mechanisms applied to vaccines. As the most traditional adjuvant, aluminum is undoubtedly safe but limited in terms of efficiency. Some COVID-19 vaccine candidates with novel or compound adjuvants have been prominent in immunogenicity and efficacy. The Special Issue aims to present the latest developments of clinical studies on COVID-19 vaccines and gather promising research or perspectives on the design of next-generation COVID-19 vaccines and immunization strategies.

Prof. Dr. Fengcai Zhu
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

COVID-19 vaccine
clinical study
effectiveness/efficacy evaluation
heterologous
prime-boost
adjuvant
structure-based design

Published Papers (6 papers)

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Research

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12 pages, 1565 KiB

Open AccessArticle

Serological Responses and Predictive Factors of Booster COVID-19 Vaccines in Patients with Hematologic Malignancies

by Chien-Tzu Huang, Ching-Ping Lee, Tzu-Yin Chen, Yi-Chang Liu, Shih-Feng Cho, Jeng-Shiun Du, Ming-Lung Yu, Chung-Feng Huang, Sheng-Fan Wang and Hui-Hua Hsiao

J. Clin. Med. 2023, 12(17), 5647; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm12175647 - 30 Aug 2023

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Abstract

Patients with hematologic malignancies are reported to have a more severe course of coronavirus disease 2019 (COVID-19) and be less responsive to vaccination. In this prospective study, we aimed to evaluate the serological responses to booster COVID-19 vaccines of Taiwanese patients with hematologic malignancies and identify potential predictive markers for effective neutralizing immunity. This study enrolled 68 patients with hematologic malignancies and 68 age- and gender-matched healthy control subjects who received three doses of vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from 1 January 2022 to 31 October 2022. The SARS-CoV-2 immunoglobulin G (IgG) spike antibody level was measured with the Abbott assay. The effective neutralization capacity was defined as an anti-spike IgG level of ≥4160 AU/mL. Among the 68 patients with hematologic malignancies, 89.7% achieved seroconversion after booster doses. Seven patients with actively treated lymphoma remained seronegative and had the lowest humoral responses among patients with different types of hematologic malignancies. Despite comparable antibody titers between patients and healthy individuals, rates of effective neutralization (66.2% vs. 86.8%, respectively; p = 0.005) were significantly reduced in patients with hematologic malignancies. In a multivariate analysis, the independent predictors for effective neutralization were a lack of B-cell-targeted agents within six months of vaccination (odds ratio, 15.2; 95% confidence interval, 2.7–84.2; p = 0.002) and higher immunoglobulin levels (odds ratio, 4.4; 95% confidence interval, 1.3–14.7; p = 0.017). In conclusion, the majority of patients with hematologic malignancies achieved seroconversion after booster vaccination. Patients with ongoing B-cell depletion and hypogammaglobinemia were identified as having negative predictive markers for effective neutralization. Full article

(This article belongs to the Special Issue Vaccine against COVID-19: Current State of the Art and Future Perspectives)

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12 pages, 821 KiB

Open AccessArticle

Increasing Antibody Responses to Five Doses of SARS-CoV-2 mRNA Vaccine in Lung Transplant Patients

by Johanna van Gemert, Fleur Steenberg, Coretta van Leer-Buter, Huib Kerstjens, Willie Steenhuis, Onno Akkerman, Erik Verschuuren and Tji Gan

J. Clin. Med. 2023, 12(12), 4125; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm12124125 - 18 Jun 2023

Cited by 2 | Viewed by 1087

Abstract

Purpose: COVID-19 causes high mortality in Lung Transplant (LTx) patients, therefore vaccination in this population is potentially life-saving. However, the antibody response is impaired after three vaccinations in LTx patients. We questioned whether this response might be increased, and therefore studied the serological IgG antibody response across up to five doses of the SARS-CoV-2 vaccine. In addition, risk factors for non-response were investigated. Methods: In this large retrospective cohort study, antibody responses were assessed after 1–5 mRNA-based SARS-CoV-2 vaccines in all LTx patients between February 2021 and September 2022. A positive vaccine response was defined as an IgG level ≥ 300 BAU/mL. Positive antibody responses due to COVID-19 infection were excluded from the analysis. Outcome and clinical parameters were compared between responders and non-responders, and multivariable logistic regression analysis was performed to determine the risk factors for vaccine-response failure. Results: The antibody responses of 292 LTx patients were analyzed. Positive antibody response to 1–5 SARS-CoV-2 vaccinations occurred in 0%, 15%, 36%, 46%, and 51%, respectively. During the study period, 146/292 (50%) of the vaccinated individuals tested positive for SARS-CoV-2 infection. The COVID-19-related mortality was 2.7% (4/146), and all four patients were non-responders. Risk factors associated with non-response to SARS-CoV-2 vaccines in univariable analyses were age (p = 0.004), chronic kidney disease (CKD) (p = 0.006), and shorter time since transplantation (p = 0.047). In the multivariable analysis, they were CKD (p = 0.043), and shorter time since transplantation (p = 0.028). Conclusion: A two- to five-dose regime of SARS-CoV-2 vaccines in LTx patients increases the probability of vaccine response and results in a cumulative vaccine response in 51% of the LTx population. LTx patient antibody response to SARS-CoV-2 vaccinations is therefore impaired, especially in patients shortly after LTx, patients with CKD, and the elderly. Full article

(This article belongs to the Special Issue Vaccine against COVID-19: Current State of the Art and Future Perspectives)

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13 pages, 1245 KiB

Open AccessArticle

The Bivalent COVID-19 Booster Immunization after Three Doses of Inactivated Vaccine Augments the Neutralizing Antibody Response against Circulating Omicron Sublineages

by Qiaren He, Shiyu Sun, Xi Chen, Zhenxiang Hu, Yan Zhang, Hua Peng, Yang-Xin Fu, Jiaming Yang and Long Chen

J. Clin. Med. 2023, 12(1), 146; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm12010146 - 24 Dec 2022

Cited by 4 | Viewed by 2706

Abstract

A fourth dose of a COVID-19 vaccine has been recommended by a number of authorities due to waning immunity over time and the emergence of immune-escaping variants. Here, we evaluated the safety and immunogenicity of the bivalent BV-01-B5 or V-01D-351 or the prototype V-01 for heterologous boosting in three-dose inactivated COVID-19 vaccine (ICV) recipients, in comparison with ICV homologous boosting. One pilot study (NCT05583357) included 20 participants randomized at 1:1, either receiving V-01D-351 or CoronaVac. The other one (NCT05585567) recruited 36 participants randomized at 2:1, either receiving BV-01-B5 or V-01, respectively. BV-01-B5, V-01D-351, and V-01 were safe and well-tolerated as heterologous booster shots after three doses of ICV, with adverse reactions predominantly being mild and moderate in severity, similar to the safety profile of ICV boosters. The bivalent V-01D-351 and BV-01-B5 and prototype V-01 booster demonstrated remarkable cross-reactive immunogenicity against the prototype and multiple emerging variants of concern (VOCs), with the geometric mean ratio (versus CoronaVac) in particular being 31.3 (500 vs. 16), 12.0 (192 vs. 16) and 8.5 (136 vs.16) against BA.4/5 14 days after the booster, respectively. Taken together, the modified bivalent-formulation V-01 boosters induced robust neutralizing responses against multiple Omicron sublineages, better than V-01 and remarkably superior to ICV booster, without compromising the safety and tolerability. Full article

(This article belongs to the Special Issue Vaccine against COVID-19: Current State of the Art and Future Perspectives)

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12 pages, 1816 KiB

Open AccessArticle

Does Influenza Vaccination Reduce the Risk of Contracting COVID-19?

by Francesc Alòs, Yoseba Cánovas Zaldúa, María Victoria Feijóo Rodríguez, Jose Luis Del Val Garcia, Andrea Sánchez-Callejas and Mª Àngels Colomer

J. Clin. Med. 2022, 11(18), 5297; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm11185297 - 08 Sep 2022

Cited by 1 | Viewed by 1867

Abstract

The concurrent timing of the COVID-19 pandemic and the seasonal occurrence of influenza, makes it especially important to analyze the possible effect of the influenza vaccine on the risk of contracting COVID-19, or in reducing the complications caused by both diseases, especially in vulnerable populations. There is very little scientific information on the possible protective role of the influenza vaccine against the risk of contracting COVID-19, particularly in groups at high-risk of influenza complications. Reducing the risk of contracting COVID-19 in high-risk patients (those with a higher risk of infection, complications, and death) is essential to improve public well-being and to reduce hospital pressure and the collapse of primary health centers. Apart from overlapping in time, COVID-19 and flu share common aspects of transmission, so that measures to protect against flu might be effective in reducing the risk of contracting COVID-19. In this study, we conclude that the risk of contracting COVID-19 is reduced if patients are vaccinated against flu, but the reduction is small (0.22%) and therefore not clinically important. When this reduction is analysed based on the risk factor suffered by the patient, statistically significant differences have been obtained for patients with cardiovascular problems, diabetics, chronic lung and chronic kidney disease; in all four cases the reduction in the risk of contagion does not reach 1%. It is worth highlighting the behaviour that is completely different from the rest of the data for institutionalized patients. The data for these patients does not suggest a reduction in the risk of contagion for patients vaccinated against the flu, but rather the opposite, a significant increase of 6%. Socioeconomic conditions, as measured by the MEDEA deprivation index, explain increases in the risk of contracting COVID-19, and awareness campaigns should be increased to boost vaccination programs. Full article

(This article belongs to the Special Issue Vaccine against COVID-19: Current State of the Art and Future Perspectives)

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10 pages, 980 KiB

Open AccessArticle

A Heterologous V-01 or Variant-Matched Bivalent V-01D-351 Booster following Primary Series of Inactivated Vaccine Enhances the Neutralizing Capacity against SARS-CoV-2 Delta and Omicron Strains

by Zhiren Zhang, Qiaren He, Wei Zhao, Yong Li, Jiaming Yang, Zhenxiang Hu, Xi Chen, Hua Peng, Yang-Xin Fu, Long Chen and Ligong Lu

J. Clin. Med. 2022, 11(14), 4164; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm11144164 - 18 Jul 2022

Cited by 15 | Viewed by 4603

Abstract

Immune escape of emerging SARS-CoV-2 variants of concern (VOCs) and waning immunity over time following the primary series suggest the importance and necessity of booster shot of COVID-19 vaccines. With the aim to preliminarily evaluate the potential of heterologous boosting, we conducted two pilot studies to evaluate the safety and immunogenicity of the V-01 or a bivalent V-01D-351 (targeting Delta and Beta strain) booster after 5–7 months of the primary series of inactivated COVID-9 vaccine (ICV). A total of 77 participants were enrolled, with 20 participants in the V-01D-351 booster study, and 27, 30 participants in the age stratified participants of V-01 booster study. The safety results showed that V-01 or V-01D-351 was safe and well-tolerated as a heterologous booster shot, with overall adverse reactions predominantly being absent or mild in severity. The immunogenicity results showed that the heterologous prime–boost immunization with V-01 or bivalent V-01D-351 booster induced stronger humoral immune response as compared with the homologous booster with ICV. In particular, V-01D-351 booster showed the highest pseudovirus neutralizing antibody titers against prototype SARS-CoV-2, Delta and Omicron BA.1 strains at day 14 post boosting, with GMTs 22.7, 18.3, 14.3 times higher than ICV booster, 6.2, 6.1, 3.8 times higher than V-01 booster (10 μg), and 5.2, 3.8, 3.5 times higher than V-01 booster (25 μg), respectively. The heterologous V-01 booster also achieved a favorable safety and immunogenicity profile in older participants. Our study has provided evidence for a flexible roll-out of heterologous boosters and referential approaches for variant-specific vaccine boosters, with rationally conserved but diversified epitopes relative to primary series, to build herd immunity against the ongoing pandemic. Full article

(This article belongs to the Special Issue Vaccine against COVID-19: Current State of the Art and Future Perspectives)

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Other

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13 pages, 2993 KiB

Open AccessSystematic Review

Efficacy of BCG Vaccination against COVID-19: Systematic Review and Meta-Analysis of Randomized Controlled Trials

by Jiayu Wen, Quanxian Liu, Daoyan Tang and Jian-Qing He

J. Clin. Med. 2023, 12(3), 1154; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm12031154 - 01 Feb 2023

Cited by 4 | Viewed by 3070

Abstract

Beneficial off-target effects of the Bacillus Calmette-Guérin (BCG) vaccination might offer general protection from respiratory tract infections. We conducted a systematic review and meta-analysis of published randomized controlled trials (RCTs) to ascertain BCG vaccination effectiveness against COVID-19. We looked up English RCTs from 1 January 2019 to 15 November 2022 in Embase, the Cochrane Library, and the Web of Science in this systematic review and meta-analysis. Nine RCTs, including 7963 participants, were included. The infection rate of COVID-19 was not decreased in people who were vaccinated with BCG (OR, 0.96; 95% CI, 0.82–1.13; I² = 4%), and the BCG vaccination group did not have decreased COVID-19 related-hospitalization (OR, 0.66; 95% CI, 0.37–1.18; I² = 42%), admission to the ICU (OR, 0.25; 95% CI, 0.05–1.18; I² = 0%), and mortality (OR, 0.64; 95% CI, 0.17–2.44; I² = 0%) compared with the control group. There is not sufficient evidence to support the use of BCG vaccination in the prevention of COVID-19 infection and severe COVID-19 and avoid overstating the role of BCG vaccination leading to its misuse. Full article

(This article belongs to the Special Issue Vaccine against COVID-19: Current State of the Art and Future Perspectives)

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