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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 1255

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 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

  • 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 (2 papers)

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Research

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
Viewed by 533
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 425
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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