Previous Article in Journal
Understanding COVID-19 Vaccination Intention in Japan: The Influence of Individual Social Capital and Personal Beliefs on Vaccination
Previous Article in Special Issue
Beyond PrEP: The Imperative for an HIV Vaccine to End the Epidemic in Africa
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
Vaccines
Volume 14
Issue 9
10.3390/vaccines14090794
vaccines-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Review

A Population-Based HIV Vaccine Efficacy Trial Design: Statistical Framework and Design Considerations

by
Holly Janes
1,*,
Fei Gao
1,
Susan Buchbinder
2,
Charles S. Wiysonge
3,
Kimberly Louis
4,
Blossom Napoleon
5,
Amelia Mfiki
6,
Derrick Mapp
7 and
Glenda Gray
8
1
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, 1100 Fairview Ave N M2-C200, Seattle, WA 98109, USA
2
Bridge HIV, San Francisco Department of Public Health, University of California, San Francisco, 25 Van Ness Avenue, Suite 100, San Francisco, CA 94114, USA
3
Cochrane South Africa, South African Medical Research Council, Francie van Zijl Drive, Parow Valley, Cape Town 7500, South Africa
4
Vaccine Trials Unit, Fred Hutchinson Cancer Center, 901 Boren Ave, #1320, Seattle, WA 98104, USA
5
Aurum Klerksdorp Clinical Research Site, Jade Square, OR Tambo Street, Klerksdorp 2570, South Africa
6
Groote Schuur Clinical Research Site, South African National Aids Council (SANAC)-Civil Society, J52 Old Main Building Groote Schuur Hospital, Cape Town 8001, South Africa
7
Shanti Project, 27 Maiden Lane, Suite 400, San Francisco, CA 94108, USA
8
Infectious Disease and Oncology Research Institute, Faculty of Health Sciences, University of the Witwatersrand, South African Medical Research Council, Tygerberg, PO Box 19070, Cape Town 7505, South Africa
*
Author to whom correspondence should be addressed.
Vaccines 2026, 14(9), 794; https://doi.org/10.3390/vaccines14090794
Submission received: 5 August 2026 / Revised: 1 September 2026 / Accepted: 3 September 2026 / Published: 9 September 2026
(This article belongs to the Special Issue The Need for an HIV Vaccine in the Era of Highly Effective PrEP)
Review Reports Versions Notes

Abstract

An HIV vaccine will be a critical tool for ending the epidemic, yet the next vaccine efficacy trial is likely five or more years away as the field focuses on the early-phase evaluation and optimization of vaccines that induce broadly neutralizing antibodies. At the same time, the HIV prevention landscape has evolved substantially, with the discovery of highly effective means of preventing HIV, challenging the identification of HIV prevention trial designs that are ethically sound and scientifically robust. We explore a population-based, individually randomized, proof-of-concept trial design for evaluating the efficacy of a future candidate vaccine to prevent HIV acquisition and to validate the neutralizing antibody marker as an immune correlate. The design is intended to lay the foundation for a subsequent licensure trial and the development and refinement of future HIV vaccine regimens. Key design features include broad, population-based eligibility criteria; the incorporation of external data; decentralized approaches to recruitment, specimen, and data collection; and strong community partnerships. We compare the approach with alternative trial designs and outline their limitations. The population-based design represents a compelling option for generating credible and generalizable evidence, while enabling future HIV vaccine licensure and development.
Keywords: HIV; vaccines; HIV prevention; bnAbs; clinical trials HIV; vaccines; HIV prevention; bnAbs; clinical trials

Share and Cite

MDPI and ACS Style

Janes, H.; Gao, F.; Buchbinder, S.; Wiysonge, C.S.; Louis, K.; Napoleon, B.; Mfiki, A.; Mapp, D.; Gray, G. A Population-Based HIV Vaccine Efficacy Trial Design: Statistical Framework and Design Considerations. Vaccines 2026, 14, 794. https://doi.org/10.3390/vaccines14090794

AMA Style

Janes H, Gao F, Buchbinder S, Wiysonge CS, Louis K, Napoleon B, Mfiki A, Mapp D, Gray G. A Population-Based HIV Vaccine Efficacy Trial Design: Statistical Framework and Design Considerations. Vaccines. 2026; 14(9):794. https://doi.org/10.3390/vaccines14090794

Chicago/Turabian Style

Janes, Holly, Fei Gao, Susan Buchbinder, Charles S. Wiysonge, Kimberly Louis, Blossom Napoleon, Amelia Mfiki, Derrick Mapp, and Glenda Gray. 2026. "A Population-Based HIV Vaccine Efficacy Trial Design: Statistical Framework and Design Considerations" Vaccines 14, no. 9: 794. https://doi.org/10.3390/vaccines14090794

APA Style

Janes, H., Gao, F., Buchbinder, S., Wiysonge, C. S., Louis, K., Napoleon, B., Mfiki, A., Mapp, D., & Gray, G. (2026). A Population-Based HIV Vaccine Efficacy Trial Design: Statistical Framework and Design Considerations. Vaccines, 14(9), 794. https://doi.org/10.3390/vaccines14090794

Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here.

Article Metrics

Back to TopTop