HIV Diagnostics and Vaccines: It Takes Two to Tango

Will Colón; Valérie Oriol Mathieu; John Hural; Lucy Hattingh; Ferdinard Adungo; Ole Lagatie; Ludo Lavreys; Mary Allen; Omu Anzala; Nicole Espy; Katrien Fransen; Patricia J Garcia; Milton Maciel Jr; Maurine Murtagh; Sheila A Peel; Rosanna W Peeling; Litjen L J Tan; Mitchell Warren; Maria Grazia Pau; Patricia M D'Souza

doi:10.1093/infdis/jiae113

HIV Diagnostics and Vaccines: It Takes Two to Tango

J Infect Dis. 2024 Mar 7:jiae113. doi: 10.1093/infdis/jiae113. Online ahead of print.

Authors

Will Colón¹, Valérie Oriol Mathieu², John Hural³, Lucy Hattingh⁴, Ferdinard Adungo⁵, Ole Lagatie¹, Ludo Lavreys², Mary Allen⁶, Omu Anzala⁷, Nicole Espy³, Katrien Fransen⁸, Patricia J Garcia⁹, Milton Maciel Jr⁶, Maurine Murtagh¹⁰, Sheila A Peel¹¹, Rosanna W Peeling¹², Litjen L J Tan¹³, Mitchell Warren¹⁴, Maria Grazia Pau², Patricia M D'Souza⁶

Affiliations

¹ Johnson & Johnson Global Public Health Research & Development, Beerse, Belgium.
² Janssen Vaccines and Prevention B.V., Leiden, the Netherlands.
³ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
⁴ LH Consulting, Berkeley, CA, USA.
⁵ Kenya Medical Research Institute, Nairobi, Kenya.
⁶ National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
⁷ Kenya Aids Vaccine Initiative (KAVI) Institute of Clinical Research, University of Nairobi, Nairobi, Kenya.
⁸ HIV/STD Reference Laboratory, Clinical Virology Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
⁹ Epidemiology, STD, and HIV Unit, School of Public Health, Universidad Peruana Cayetano Heredia, Lima, Peru.
¹⁰ The Murtagh Group, LLC, Woodside, CA, USA.
¹¹ Diagnostics and Countermeasures Branch, Walter Reed Army Institute of Research, Silver Spring, MD, USA.
¹² Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.
¹³ Immunize.org, Saint Paul, MN, USA.
¹⁴ AVAC, New York, NY, USA.

PMID: 38451247
DOI: 10.1093/infdis/jiae113

Abstract

Current serological tests for HIV screening and confirmation of infection present challenges to the adoption of HIV vaccines. The detection of vaccine-induced HIV-1 antibodies in the absence of HIV-1 infection, referred to as vaccine-induced seropositivity/seroreactivity, confounds the interpretation of test results, causing misclassification of HIV-1 status with potential affiliated stigmatization. For HIV vaccines to be widely adopted with high community confidence and uptake, tests that are agnostic to vaccination status (i.e., only positive for true HIV-1 infection) of tested individuals are needed. Successful development and deployment of such tests will require HIV vaccine developers to work in concert with diagnostic developers. Such tests will need to match today's high-performance standards (accuracy, cost-effectiveness, simplicity) for use in both vaccinated and unvaccinated populations, especially in low- and middle-income countries with high HIV burden. Herein, we discuss the challenges and strategies for developing modified serological HIV tests for concurrent deployment with HIV vaccines.

Keywords: HIV; antibodies; diagnostics; vaccine; vaccine-induced seropositivity/seroreactivity.