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

• Published in: Vaccine Vol. 42; no. 20; pp. 125991 - None
• Main Authors: Chihana, Rachel, Jin Kee, Jia, Moodie, Zoe, Huang, Yunda, Janes, Holly, Dadabhai, Sufia, Roxby, Alison C., Allen, Mary, Kassim, Sheetal, Naicker, Vimla, Innes, Craig, Naicker, Nivashnee, Dubula, Thozama, Grunenberg, Nicole, Malahleha, Mookho, Kublin, James G., Bekker, Linda-Gail, Gray, Glenda, Kumwenda, Johnstone, Laher, Fatima
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 13-08-2024; Elsevier Limited; Elsevier Science
• Subjects: Acquired immune deficiency syndrome; Adolescent; Adult; Age; AIDS; AIDS Vaccines - administration & dosage; AIDS Vaccines - adverse effects; AIDS Vaccines - immunology; Arthralgia; Body mass index; Chills; Clinical trials; COVID-19 vaccines; Disease transmission; Double-Blind Method; Female; Females; Fever; Gender; Glycoprotein gp120; Glycoproteins; Headaches; HIV; HIV Infections - prevention & control; Human immunodeficiency virus; Humans; Immunization; Male; Medical research; Myalgia; Pain; Placebos; Provinces; Reactogenicity; Region; Sex; Sexually transmitted diseases; Short Communication; Sociodemographics; STD; Vaccine; Vaccine Efficacy; Vaccines; Young Adult; South Africa; KwaZulu-Natal Province South Africa; Region; Vaccine; Gender; HIV; Reactogenicity; Age
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2024.05.039

•Those assigned female at birth experience more reactogenicity.•Most symptoms are mild.•Pain and/or tenderness symptom common in both vaccine and placebo groups.
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.
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.
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).
Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.