Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Rachel Chihana; Jia Jin Kee; Zoe Moodie; Yunda Huang; Holly Janes; Sufia Dadabhai; Alison C Roxby; Mary Allen; Sheetal Kassim; Vimla Naicker; Craig Innes; Nivashnee Naicker; Thozama Dubula; Nicole Grunenberg; Mookho Malahleha; James G Kublin; Linda-Gail Bekker; Glenda Gray; Johnstone Kumwenda; Fatima Laher

doi:10.1016/j.vaccine.2024.05.039

Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Vaccine. 2024 Aug 13;42(20):125991. doi: 10.1016/j.vaccine.2024.05.039. Epub 2024 May 21.

Authors

Rachel Chihana¹, Jia Jin Kee², Zoe Moodie², Yunda Huang², Holly Janes², Sufia Dadabhai³, Alison C Roxby⁴, Mary Allen⁵, Sheetal Kassim⁶, Vimla Naicker⁷, Craig Innes⁸, Nivashnee Naicker⁹, Thozama Dubula¹⁰, Nicole Grunenberg², Mookho Malahleha¹¹, James G Kublin², Linda-Gail Bekker⁶, Glenda Gray¹², Johnstone Kumwenda³, Fatima Laher¹²

Affiliations

¹ Johns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi. Electronic address: [email protected].
² Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
³ Johns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi.
⁴ University of Washington, P.O Box 355852, WA 98195-5852, USA; Fred Hutchinson Cancer Center, P.O Box 19024, WA 98109-1024, Seattle, USA.
⁵ National Institutes of Health, 9000, Rockville Pike, Bethesda, USA.
⁶ The Desmond Tutu HIV Centre, P.O Box 13801, Mowbray 7705, Cape Town, South Africa.
⁷ South Africa Medical Research Council, P.O Box 19070, Cape Town, South Africa.
⁸ Aurum Institute, The Ridge, 29 Queens Road, Johannesburg, South Africa.
⁹ Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Private Bag X7, Durban, South Africa.
¹⁰ Walter Sisulu University, P. O Box 142, Eastern Cape, South Africa.
¹¹ Setshaba Research Centre, P.O Box 468, Pretoria, South Africa; Synergy Biomed Research Institute, 280 Oxford Street, East London 5201, South Africa.
¹² Perinatal HIV Research Unit, P.O Box 114, University of the Witwatersrand, South Africa.

Abstract

Background: Reactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products.

Methods: HVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18-35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables.

Results: More vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (OR_v = 2.50, OR_p = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002).

Conclusion: Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

Keywords: Age; Gender; HIV; Reactogenicity; Region; Vaccine.

Publication types

Randomized Controlled Trial
Clinical Trial, Phase II
Clinical Trial, Phase III

MeSH terms

AIDS Vaccines* / administration & dosage
AIDS Vaccines* / adverse effects
AIDS Vaccines* / immunology
Adolescent
Adult
Double-Blind Method
Female
HIV Infections* / prevention & control
Humans
Male
Vaccine Efficacy
Young Adult

Substances

AIDS Vaccines

Abstract

Publication types

MeSH terms

Substances

Grants and funding