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

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

Rachel Chihana  1 , Jia Jin Kee  2 , Zoe Moodie  2 , Yunda Huang  2 , Holly Janes  2 , Sufia Dadabhai  3 , Alison C Roxby  4 , Mary Allen  5 , Sheetal Kassim  6 , Vimla Naicker  7 , Craig Innes  8 , Nivashnee Naicker  9 , Thozama Dubula  10 , Nicole Grunenberg  2 , Mookho Malahleha  11 , James G Kublin  2 , Linda-Gail Bekker  6 , Glenda Gray  12 , Johnstone Kumwenda  3 , Fatima Laher  12
Affiliations
Clinical Trial

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

Rachel Chihana et al. Vaccine. .

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 (ORv = 2.50, ORp = 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.

Trial registration: ClinicalTrials.gov NCT02968849.

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

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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