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Vaccines
Special Issues
Safety and Immunogenicity of Vaccination
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Safety and Immunogenicity of Vaccination

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

Deadline for manuscript submissions: 31 May 2026 | Viewed by 10632

Special Issue Editor

Dr. Jennifer Serwanga

E-Mail Website
Guest Editor
1. Department of Immunology, Uganda Virus Research Institute, Entebbe P.O. Box 49, Uganda
2. Medical Research Council, Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe P.O. Box 49, Uganda
3. London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK
Interests: immunology of viral infections; vaccine safety and immunogenicity; monoclonal antibody discovery; host–pathogen interactions; immune correlates of protection; epidemic preparedness; translational research for emerging and re-emerging infectious diseases

Special Issue Information

Dear Colleagues,

Vaccination remains one of the most transformative public health interventions. However, the increasing diversity of vaccine platforms, from mRNA and viral-vectored to protein subunit and inactivated vaccines, necessitates continuous evaluation of safety and immunogenicity profiles across populations, including vulnerable subgroups. This Special Issue aims to collate cutting-edge research, clinical trial outcomes, and mechanistic insights into vaccine-induced immune responses. The issue will serve to guide those working to ensure the safety and effectiveness of vaccines, especially in the context of vaccine preparedness. We welcome original articles, systematic reviews, and short communications that address:

  • Preclinical and clinical safety profiles of emerging vaccine candidates;
  • Kinetics and quality of immune responses (e.g., durability, breadth, avidity);
  • Correlates of protection across different vaccine platforms;
  • Comparative immunogenicity across age groups, immunocompromised individuals, and special populations;
  • Biomarkers for vaccine efficacy and adverse events;
  • Innovations in vaccine formulation, delivery, and adjuvant systems.

This issue will serve as a reference point for scientists, regulators, and policymakers working to ensure the safety and effectiveness of next-generation vaccines, particularly in the context of pandemic preparedness and global equity.

Dr. Jennifer Serwanga
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 250 words) can be sent to the Editorial Office for assessment.

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

  • vaccine safety
  • immunogenicity profiling
  • correlates of protection
  • vaccine-induced immunity
  • dose optimization and adjuvants
  • breakthrough infections
  • long-term immune memory
  • vaccines in special populations

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Further information on MDPI's Special Issue policies can be found here.

Published Papers (5 papers)

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18 pages, 6383 KB  
Article
Adjuvanted Recombinant Hemagglutinin Vaccine Provides Durable and Broad-Spectrum Immunogenicity in Mice
by Rui Yu, Yan Guo, Senyan Zhang, Yuanbao Ai, Rui Wei, Yan Li, Hang Chen, Shuyun Liu, Caixia Zhang, Yuanfeng Yao, Meng Lv, Yingying Li, Yulin Chen, Peng Zhou, Siting Tu, Meijuan Fu, Yongshun Su, Yu Lin, Min Yang, Yanbin Ding, Siyu Tian, Cai Jing, Hang Chen, Tao Ma, Chunping Deng, Yu Zhou, Yuanyuan Li and Jing Jinadd Show full author list remove Hide full author list
Vaccines 2025, 13(11), 1162; https://doi.org/10.3390/vaccines13111162 - 14 Nov 2025
Viewed by 698
Abstract
Background: Seasonal influenza vaccines must be reformulated annually due to the high genetic variability and antigenic drift of circulating influenza viruses. The annual update, guided by World Health Organization (WHO) recommendations, results in significant challenges, including compressed production time periods, elevated manufacturing [...] Read more.
Background: Seasonal influenza vaccines must be reformulated annually due to the high genetic variability and antigenic drift of circulating influenza viruses. The annual update, guided by World Health Organization (WHO) recommendations, results in significant challenges, including compressed production time periods, elevated manufacturing costs, and global distribution pressures. Moreover, mismatches between vaccine strains and circulating viruses can severely reduce protective efficacy, underscoring the urgent need for broadly protective and long-lasting influenza vaccines. Methods: In this study, we developed an adjuvanted trivalent recombinant influenza virus-like particle vaccine (a-RIV) using the baculovirus–insect cell expression system and formulated it with an AS01-like adjuvant. The vaccine comprises full-length hemagglutinin (HA) proteins from WHO-recommended seasonal influenza strains: A/H1N1 (AH1), A/H3N2 (AH3), and B/Victoria (B/vic) lineages. The purified HA proteins were subsequently formulated with a liposomal adjuvant to enhance the immunogenicity. Results: In mouse immunization studies, the a-RIV vaccine elicited significantly stronger humoral and cellular immune responses than the licensed recombinant vaccine Flublok and the conventional inactivated influenza vaccine (IIV). High levels of functional anti-HA antibodies and antigen-specific T cell responses persisted for at least six months post-vaccination. Moreover, a-RIV induced broadly reactive antibodies capable of cross-binding to heterologous AH1 and AH3 influenza strains. Conclusions: Our data demonstrate that the a-RIV elicits enhanced, durable, and broadly cross-reactive immune responses against multiple influenza subtypes. These findings support the potential of adjuvanted recombinant HA-based vaccine as a promising candidate for the development of next-generation influenza vaccine. Full article
(This article belongs to the Special Issue Safety and Immunogenicity of Vaccination)
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14 pages, 926 KB  
Article
Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) in Chinese Children, Adults and the Elderly: A Phase 4, Randomized, Double-Blind, Active-Controlled Clinical Trial
by Xiaoyu Liu, Gang Shi, Yuanyuan Dong, Wanqi Yang, Yinan Wang, Xianying Ye, Juxiang Zhang, Xinyi Yang, Dan Yu, Dan Song, Yuehong Ma, Zeng Wang, Hong Li and Weijun Hu
Vaccines 2025, 13(8), 866; https://doi.org/10.3390/vaccines13080866 - 15 Aug 2025
Cited by 2 | Viewed by 2886
Abstract
Objectives: This randomized, double-blind, active-controlled non-inferiority phase 4 clinical trial was conducted to evaluate the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine (PPSV23) compared to an active comparator vaccine. Methods: Pneumococcal vaccine-naïve participants aged ≥2 years were randomly assigned in a [...] Read more.
Objectives: This randomized, double-blind, active-controlled non-inferiority phase 4 clinical trial was conducted to evaluate the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine (PPSV23) compared to an active comparator vaccine. Methods: Pneumococcal vaccine-naïve participants aged ≥2 years were randomly assigned in a 2:1 ratio to receive a single dose of either the investigational vaccine (n = 1199) or the comparator vaccine (n = 600). Immunogenicity was evaluated at baseline and 30 days post-vaccination by measuring serotype-specific IgG antibodies against all 23 pneumococcal serotypes using enzyme-linked immunosorbent assay. The primary outcome was seroconversion, defined as a ≥two-fold increase in serotype-specific IgG antibody titers at day 30 compared to baseline. Results: At one month post-vaccination, seroconversion rates for each of the 23 serotypes ranged from 59.22% to 95.67% in the treatment group, compared to 59.66% to 94.07% in the control group. Non-inferiority was demonstrated for all serotypes, with the lower bounds of the 95% confidence intervals (95%CI) for rate differences exceeding the predefined −10% margin. Moreover, superiority was observed for 12 serotypes (6B, 23F, 1, 2, 4, 8, 9N, 9V, 11A, 15B, 17F and 18C), as the lower bounds of their 95%CI for rate differences were above 0. Adverse reactions were reported in 236 (19.68%) participants of the investigational group and 118 (19.67%) of the control group within 30 days post-vaccination, with no significant differences between groups. Conclusions: The PPSV23 vaccine administered among individual aged ≥2 years was safe, well tolerated and immunogenic, eliciting an immune response either comparable to or higher than control vaccine. These findings support its use as a safe and effective option for pneumococcal immunization. Full article
(This article belongs to the Special Issue Safety and Immunogenicity of Vaccination)
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15 pages, 1206 KB  
Article
Counterfactual Groups to Assess Vaccine or Treatment Efficacy in HIV Prevention Trials in High-Risk Populations in Uganda
by Andrew Abaasa, Yunia Mayanja, Zacchaeus Anywaine, Sylvia Kusemererwa, Eugene Ruzagira and Pontiano Kaleebu
Vaccines 2025, 13(8), 844; https://doi.org/10.3390/vaccines13080844 - 8 Aug 2025
Viewed by 1050
Abstract
Background: Assessment of efficacy in HIV prevention trials remains a challenge in the era of widespread use of active controls. We investigated use of counterfactual groups to assess treatment efficacy. Methods: We used data from placebo arms of two previous HIV prevention efficacy [...] Read more.
Background: Assessment of efficacy in HIV prevention trials remains a challenge in the era of widespread use of active controls. We investigated use of counterfactual groups to assess treatment efficacy. Methods: We used data from placebo arms of two previous HIV prevention efficacy trials (Pro2000 vaginal microbicide trial, 2005–2009: ISRCTN64716212 and dapivirine vaginal ring trial, 2013–2016: NCT01539226) and four observational cohorts (two in each of the periods; (a) during the conduct of a simulated HIV vaccine efficacy trial (SiVET), 2012–2017, and (b) prior to SiVET (2005–2011)) and compared HIV prevention efficacy trial targeted outcomes with SiVETs. SiVET participants were administered a licensed hepatitis B vaccine at 0, 1 and 6 months mimicking an HIV vaccine efficacy trial schedule. Participants were tested for HIV quarterly for one year. The probability of the SiVET assignment conditioned on the measured participants’ baseline characteristics were estimated using propensity scores (PS) and matched between SiVET and placebo arm of trials. Similar calculations were repeated for observational cohorts in the pre- and during SiVET periods. We compared HIV incidence rate ratio (IRR) between SiVET and the trials or observational data before and after PS matching. Results: This analysis involved data from 3387 participants; observational cohorts before SiVET 1495 (44.2%), placebo arms of previous trials 367 (10.8%), observational cohorts during SiVET conduct 953 (28.1%) and SiVETs 572 (16.9%). Before propensity score matching (PSM), there were significant imbalances in participants’ baseline characteristics between SiVET, and all the other studies and HIV incidence was lower in SiVET. After PSM, the participants’ characteristics were comparable. The HIV incidence in SiVET was similar to that in the previous trial, IRR = 1.01 95% CI: 0.16–4.70), p = 0.968, and observational data during SiVET, IRR = 0.74, 95% CI 0.34–1.54), p = 0.195, but much lower compared to the observational data pre-SiVET, IRR = 0.48, 95% CI: 0.20–1.04), p = 0.023. Conclusions: PSM can be used to create counterfactual groups from other data sources. The best counterfactual group for assessing treatment effect is provided by data collected in the placebo arm of previous trials followed by that from observational data collected concurrently to the current trial (SiVET). Even with PSM, observational data collected prior to the current trial may overestimate treatment effect. Full article
(This article belongs to the Special Issue Safety and Immunogenicity of Vaccination)
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19 pages, 5627 KB  
Systematic Review
Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine Versus a 13-Valent Vaccine in Infants: A Systematic Review and Meta-Analysis
by María-Dolores Pacheco-Haro, Sergio Núñez de Arenas-Arroyo, Valentina Díaz-Goñi, Elisa-Janeth Velasco-Lucio, Carol-Ingrid Castellares-González, Valeria Reynolds-Cortez, Adriana Simeón-Prieto, Elsa Ignateva and Vicente Martínez-Vizcaíno
Vaccines 2025, 13(11), 1156; https://doi.org/10.3390/vaccines13111156 - 12 Nov 2025
Viewed by 1547
Abstract
Background/Objectives: The 20-valent pneumococcal conjugate vaccine (PCV20) was approved for use in children and infants on the basis of studies comparing its safety and immunogenicity with those of the 13-valent vaccine (PCV13). PCV20 offers expanded coverage of seven additional serotypes. This meta-analysis aimed [...] Read more.
Background/Objectives: The 20-valent pneumococcal conjugate vaccine (PCV20) was approved for use in children and infants on the basis of studies comparing its safety and immunogenicity with those of the 13-valent vaccine (PCV13). PCV20 offers expanded coverage of seven additional serotypes. This meta-analysis aimed to summarize the available evidence on the comparative immunogenicity between PCV20 and PCV13. Methods: A systematic search of the PubMed, Web of Science, Scopus, Cochrane, and ClinicalTrials.gov databases was conducted in September 2024. The following inclusion criteria were used: (i) design: randomized clinical trials; (ii) outcomes: studies that included immunogenicity outcomes; (iii) compared vaccines: any study directly comparing the immunogenicity of PCV20 and PCV13; and (iv) population: infant population <2 years of age. No language or temporal restrictions were applied in the study. A random-effects meta-analysis was conducted via the Hartung–Knapp–Sidik–Jonkman method, with subgroup analyses according to the serotype and vaccination schedule (3 + 1 and 2 + 1). We used the revised Cochrane risk of bias 2 tool (RoB 2.0) to assess the risk of bias. The following parameters of immunogenicity were estimated: (i) the pooled geometric mean ratio (GMR PCV20/PCV13) of serotype-specific pneumococcal anticapsular antibodies, (ii) the pooled difference (PCV20-PCV13) in the percentage (DP) of participants who achieved predefined antibody levels for each serotype, and (iii) the pooled geometric mean titres (GMTs) of serotype-specific opsonophagocytic activity (OPA) in PCV20 and PCV13, along with their 95% confidence intervals (95% CIs). Results: Four studies (4093 infants aged 42–180 days) that compared the PCV20 and PCV13 vaccines, published between 2021 and 2024, were included in this meta-analysis. The immunogenicity of both groups was compared one month after the primary series and one month after the booster dose. The pooled results indicated that PCV20 elicited lower immune responses for the 13 serotypes shared with PCV13, according to the GMR and OPA outcomes. For the DP outcome, no statistically significant differences were observed between the two groups. Immune responses were higher for the additional serotypes in the PCV20 group; however, these differences were not statistically significant for all serotypes. Conclusions: This meta-analysis offers an overview of the evidence on the comparative immunogenicity of PCV20 and PCV13. Although some outcomes indicate that PCV20 elicits lower immune responses for the 13 serotypes shared with PCV13, it provides immunity against seven additional serotypes associated with IPD. Further studies are warranted to strengthen the evidence base, and continuous IPD surveillance remains essential to monitor shifts in serotype prevalence, assess the impact of current and future vaccines, and guide vaccine policy recommendations. Full article
(This article belongs to the Special Issue Safety and Immunogenicity of Vaccination)
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9 pages, 223 KB  
Brief Report
Interim Vaccine Effectiveness Against Influenza and Hospitalization, Republic of Korea, 2024–2025 (HIMM Network)
by Yu Jung Choi, Joon Young Song, Seong-Heon Wie, Jacob Lee, Jin-Soo Lee, Hye Won Jeong, Joong Sik Eom, Jang Wook Sohn, Won Suk Choi, Eliel Nham, Jin Gu Yoon, Ji Yun Noh and Hee Jin Cheong
Vaccines 2025, 13(11), 1100; https://doi.org/10.3390/vaccines13111100 - 28 Oct 2025
Viewed by 3938
Abstract
Background: Influenza cases have surged earlier than usual during the 2024–2025 season, with A/H1N1 (pdm09) being the dominant strain. We aimed to investigate early estimates of influenza vaccine effectiveness (VE) for the 2024–2025 season to enhance our influenza response strategies. Methods: [...] Read more.
Background: Influenza cases have surged earlier than usual during the 2024–2025 season, with A/H1N1 (pdm09) being the dominant strain. We aimed to investigate early estimates of influenza vaccine effectiveness (VE) for the 2024–2025 season to enhance our influenza response strategies. Methods: From November 1 to December 31, 2024, we enrolled 990 individuals with influenza-like illness from the hospital-based influenza surveillance network (Hospital-Based Influenza Morbidity and Mortality, HIMM), which consists of eight hospitals. Results: The overall adjusted VE was estimated to be −0.5% (95% confidence interval [CI], −34.0 to 24.6), with 0.4% (95% CI, −33.2 to 25.5) for influenza A. Analyses by influenza subtype were exploratory, given the limited number of subtyped cases. Although ineffective in preventing laboratory-confirmed influenza, influenza vaccination reduced influenza-related hospitalizations by 31.9% (95% CI, 3.5 to 51.9). Conclusions: It is necessary to enhance influenza vaccine effectiveness by selecting better-matched vaccine strains and introducing immune-enhanced vaccines. Full article
(This article belongs to the Special Issue Safety and Immunogenicity of Vaccination)
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