Related Experiment Video
Updated: Jun 25, 2025
New Tools to Expand Regulatory T Cells from HIV-1-infected Individuals
Published on: May 30, 2013
Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702
Rachel Chihana1, Jia Jin Kee2, Zoe Moodie2
1Johns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi.
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.
