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Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV...
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Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Vaccine Efficacy and Safety".

Deadline for manuscript submissions: 30 June 2025 | Viewed by 4689

Special Issue Editor

Dr. Roland Zahn

E-Mail Website
Guest Editor
Janssen Prevention Center, 2333 CN Leiden, The Netherlands
Interests: COVID; vaccine; influenza; RSV
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Prophylactic vaccines against influenza and COVID-19 have been given to billions of individuals repeatedly and are effective for the prevention of severe disease. While the safety and efficacy of current influenza vaccines are established based on decades of use, new vaccine concepts to achieve higher efficacy, protection against infection and preferentially more universal protection have a yet-to-be-defined immunogenicity, safety and efficacy profile. Some of these new vaccine concepts have been used for the rapidly developed and licensed COVID-19 vaccines. These have shown to be safe, with a high efficacy against severe disease; however, safety concerns about rare cases of myocarditis, Guillain–Barré syndrome (GBS) and vaccine-induced immune thrombotic thrombocytopenia (VITT) became apparent shortly after vaccination, requiring further research to understand their etiology and long-term consequences. Recently, after decades of RSV, disease-targeting vaccines have been approved and are either based on more traditional subunits or mRNA technology. Understandings of long-term efficacy, immunogenicity and safety are limited and will add to our understanding of effective vaccines against viral respiratory infections.

In this Special Issue, we will collect original research on the immunogenicity, efficacy and safety evaluations of vaccines against influenza, RSV and SARS-CoV-2, preclinical and clinical research with candidate or licensed vaccines and long-term follow-up studies.

Dr. Roland Zahn
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. Vaccines is an international peer-reviewed open access monthly 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 2700 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

  • influenza
  • respiratory syncytial virus (RSV)
  • COVID-19
  • SARS-CoV-2
  • vaccines
  • immunogenicity
  • efficacy
  • safety
  • universal vaccine

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Published Papers (5 papers)

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Research

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15 pages, 2239 KiB  
Article
Profile of Humoral Immunity and B Cell Pool in Infection with the SARS-CoV-2 Prototype Strain and AZD1222 (ChAdOx nCoV-19) Vaccination
by Débora Familiar-Macedo, Elzinandes Leal de Azeredo, Elba Regina Sampaio de Lemos, Paulo Vieira Damasco and Luzia Maria de-Oliveira-Pinto
Vaccines 2025, 13(2), 101; https://doi.org/10.3390/vaccines13020101 - 21 Jan 2025
Viewed by 957
Abstract
Background/Objectives: Understanding the behavior of B cells during infection and vaccination is important for determining protective humoral immunity. We evaluated the profile of humoral immunity and B cell pool in individuals who were acutely infected with SARS-CoV-2, recovered from COVID-19, or received two [...] Read more.
Background/Objectives: Understanding the behavior of B cells during infection and vaccination is important for determining protective humoral immunity. We evaluated the profile of humoral immunity and B cell pool in individuals who were acutely infected with SARS-CoV-2, recovered from COVID-19, or received two doses of the AZD1222 vaccine. Methods: Peripheral blood mononuclear cells (PBMCs) from these individuals were subjected to in vitro stimulation to promote the differentiation of B cells into antibody-secreting cells (ASCs), and the ELISpot evaluated the abundance of pan and SARS-CoV-2 Spike S1-reactive IgG+ ASC. Stimulated PBMCs were characterized using flow cytometry. Culture supernatants were assessed for soluble B-cell-activating factors. The IgA and IgG for the S1 were evaluated through ELISA. Results: The recovered individuals displayed a robust S1 ASC compared to acute and vaccinated individuals. Although the frequency of total B cells or B cell subsets did not vary among the groups, plasmablast cells were increased in naïve and double-negative B cells in the acute, recovered, and vaccinated individuals. Similar IgA and IgG production appeared to be present in the acute and recovered individuals. During vaccination, more IgG is produced than IgA. In acute patients, BAFF levels were positively correlated with total B cells and IgG+ plasmablast cells but negatively correlated with IgA+ plasmablast cells. Conclusions: Vaccination and natural infection with COVID-19 induce a differential profile and functionality of B cells. We suggest that new vaccines against COVID-19 incorporate molecular adjuvants that regulate B lymphocyte functionality and consider the beneficial aspects of the IgA response in addition to IgG. Full article
(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)
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21 pages, 5843 KiB  
Article
Mucosal Immunization with an Influenza Vector Carrying SARS-CoV-2 N Protein Protects Naïve Mice and Prevents Disease Enhancement in Seropositive Th2-Prone Mice
by Mariia V. Sergeeva, Kirill Vasilev, Ekaterina Romanovskaya-Romanko, Nikita Yolshin, Anastasia Pulkina, Daria Shamakova, Anna-Polina Shurygina, Arman Muzhikyan, Dmitry Lioznov and Marina Stukova
Vaccines 2025, 13(1), 15; https://doi.org/10.3390/vaccines13010015 - 28 Dec 2024
Viewed by 1117
Abstract
Background/Objectives: Intranasal vaccination enhances protection against respiratory viruses by providing stimuli to the immune system at the primary site of infection, promoting a balanced and effective response. Influenza vectors with truncated NS1 are a promising vaccine approach that ensures a pronounced local CD8+ [...] Read more.
Background/Objectives: Intranasal vaccination enhances protection against respiratory viruses by providing stimuli to the immune system at the primary site of infection, promoting a balanced and effective response. Influenza vectors with truncated NS1 are a promising vaccine approach that ensures a pronounced local CD8+ T-cellular immune response. Here, we describe the protective and immunomodulating properties of an influenza vector FluVec-N carrying the C-terminal fragment of the SARS-CoV-2 nucleoprotein within a truncated NS1 open reading frame. Methods: We generated several FluVec-N recombinant vectors by reverse genetics and confirmed the vector’s genetic stability, antigen expression in vitro, attenuation, and immunogenicity in a mouse model. We tested the protective potential of FluVec-N intranasal immunization in naïve mice and seropositive Th2-prone mice, primed with aluminium-adjuvanted inactivated SARS-CoV-2. Immune response in immunized and challenged mice was analyzed through serological methods and flow cytometry. Results: Double intranasal immunization of naïve mice with FluVec-N reduced weight loss and viral load in the lungs following infection with the SARS-CoV-2 beta variant. Mice primed with alum-adjuvanted inactivated coronavirus experienced substantial early weight loss and eosinophilia in the lungs during infection, demonstrating signs of enhanced disease. A single intranasal boost immunization with FluVec-N prevented the disease enhancement in primed mice by modulating the local immune response. Protection was associated with the formation of specific IgA and the early activation of virus-specific effector and resident CD8+ lymphocytes in mouse lungs. Conclusions: Our study supports the potential of immunization with influenza vector vaccines to prevent respiratory diseases and associated immunopathology. Full article
(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)
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15 pages, 1956 KiB  
Article
Impact of Anti-SARS-CoV-2 Vaccination on Disease Severity and Clinical Outcomes of Individuals Hospitalized for COVID-19 Throughout Successive Pandemic Waves: Data from an Italian Reference Hospital
by Annalisa Mondi, Ilaria Mastrorosa, Assunta Navarra, Claudia Cimaglia, Carmela Pinnetti, Valentina Mazzotta, Alessandro Agresta, Angela Corpolongo, Alberto Zolezzi, Samir Al Moghazi, Laura Loiacono, Maria Grazia Bocci, Giulia Matusali, Alberto D’Annunzio, Paola Gallì, Fabrizio Maggi, Francesco Vairo, Enrico Girardi and Andrea Antinori
Vaccines 2024, 12(9), 1018; https://doi.org/10.3390/vaccines12091018 - 6 Sep 2024
Cited by 2 | Viewed by 1043
Abstract
This is a retrospective observational study including all COVID-19 patients admitted at our Institute throughout three successive pandemic waves, from January 2021 to June 2023. The main in-hospital outcomes (clinical progression [CP], defined as admission to Intensive Care Unit [ICU]/death, and death within [...] Read more.
This is a retrospective observational study including all COVID-19 patients admitted at our Institute throughout three successive pandemic waves, from January 2021 to June 2023. The main in-hospital outcomes (clinical progression [CP], defined as admission to Intensive Care Unit [ICU]/death, and death within 28 days) were compared among participants unvaccinated (NV), fully vaccinated (FV), with one (FV&B1) and two (FV&B2) booster doses. Vaccinated participants were stratified into recently and waned FV/FV&B1/FV&B2, depending on the time elapsed from last dose (≤ and >120 days, respectively). There were 4488 participants: 2224 NV, 674 FV, 1207 FV&B1, and 383 FV&B2. Within 28 days, there were 604 ICU admissions, 396 deaths, and 737 CP. After adjusting for the main confounders, the risk of both in-hospital outcomes was reduced in vaccinated individuals, especially in those who received the booster dose (approximately by 36% for FV and >50% for FV&B1 and FV&B2 compared to NV). Similarly, after restricting the analysis to vaccinated participants only, we observed a risk reduction of approximately 40% for FV&B1 and 50% for FV&B2, compared to FV, regardless of the distance since the last dose. Our data confirm the vaccine’s effectiveness in preventing severe COVID-19 and support the efforts to increase the uptake of booster doses, mainly among older and frailer individuals, still at a greater risk of clinical progression. Full article
(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)
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Review

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19 pages, 309 KiB  
Review
Cardiopulmonary Effects of COVID-19 Vaccination: A Comprehensive Narrative Review
by Lauren T. Forchette, Luis Palma, Christian Sanchez, Rebecca M. Gibons, Christoph A. Stephenson-Moe and Benjamin J. Behers
Vaccines 2025, 13(6), 548; https://doi.org/10.3390/vaccines13060548 - 22 May 2025
Viewed by 268
Abstract
Coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines have been associated with numerous side effects since their widespread release to the public. Cardiovascular complications include myocarditis and pericarditis, Takotsubo cardiomyopathy, postural orthostatic tachycardia syndrome (POTS), arrhythmias, sudden cardiac death, and cardiac tamponade. Pulmonary [...] Read more.
Coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines have been associated with numerous side effects since their widespread release to the public. Cardiovascular complications include myocarditis and pericarditis, Takotsubo cardiomyopathy, postural orthostatic tachycardia syndrome (POTS), arrhythmias, sudden cardiac death, and cardiac tamponade. Pulmonary complications are pulmonary embolism (PE), interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), pneumonia, eosinophilic granulomatosis with polyangiitis, pneumonitis, and pulmonary hypertension. Despite these complications, the risk–benefit analysis still strongly favors vaccination, as these events occur more frequently with natural infection and confer a significantly worse prognosis. This study outlines the evidence surrounding each attributed effect, the clinical course including diagnosis and management, and the proposed pathophysiology. To our knowledge, this is the most comprehensive review of the cardiopulmonary effects of COVID-19 vaccination to date. Full article
(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

Other

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16 pages, 1348 KiB  
Protocol
A Post-Authorisation Safety Study of a Respiratory Syncytial Virus Vaccine in Pregnant Women and Their Offspring in a Real-World Setting: Generic Protocol for a Target Trial Emulation
by Odette de Bruin, Linda Nab, Jungyeon Choi, Oisin Ryan, Hae-Won Uh, Fariba Ahmadizar, Shahar Shmuel, Heather Rubino, Kitty Bloemenkamp, Cynthia de Luise and Miriam Sturkenboom
Vaccines 2025, 13(3), 272; https://doi.org/10.3390/vaccines13030272 - 5 Mar 2025
Viewed by 800
Abstract
Background: Assessing the real-world safety of preventive products against respiratory syncytial virus (RSV) in pregnant women holds significant public health implications, especially as vaccination programs become more widespread. This generic protocol describes a post-authorisation safety study (PASS) to evaluate the safety of RSV [...] Read more.
Background: Assessing the real-world safety of preventive products against respiratory syncytial virus (RSV) in pregnant women holds significant public health implications, especially as vaccination programs become more widespread. This generic protocol describes a post-authorisation safety study (PASS) to evaluate the safety of RSV vaccination in pregnant women using a target trial emulation framework. Methods: This generic protocol, adapted from an ongoing PASS, is designed using the target trial emulation framework to evaluate the safety of an RSV vaccine in pregnant women. Emulating target trial conditions have the ability to minimise confounding and bias. In this pragmatic real-world observational study, RSV-vaccinated pregnant women are matched (1:N) with unexposed women based on gestational age, calendar time, maternal age, immunocompromised status, and high-risk pregnancy. Key adverse outcomes include preterm birth, stillbirth, hypertensive disorders of pregnancy, Guillain-Barré Syndrome (GBS), low birth weight (LBW), and small for gestational age (SGA). Future studies may add additional outcomes per vaccine risk profile and Global Alignment of Immunization safety Assessment (GAIA) recommendations. Distinguishing outcomes measured during pregnancy from those assessed at or after birth is crucial for analysis and interpretation. Conclusions: This protocol offers a structured approach to evaluating the safety of RSV vaccines in pregnant women. It aims to guide researchers in designing studies and should be adapted to specific settings and data availability. Full article
(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)
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