Safety and Immunogenicty 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 260

Special Issue Editor


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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

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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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Published Papers (1 paper)

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Research

15 pages, 1206 KiB  
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
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 Immunogenicty of Vaccination)
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