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

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

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.

Afiliação

Chihana R; Johns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi. Electronic address: rkawalazira@jhp.mw.
Jin Kee J; Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Moodie Z; Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Huang Y; Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Janes H; Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Dadabhai S; Johns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi.
Roxby AC; University of Washington, P.O Box 355852, WA 98195-5852, USA; Fred Hutchinson Cancer Center, P.O Box 19024, WA 98109-1024, Seattle, USA.
Allen M; National Institutes of Health, 9000, Rockville Pike, Bethesda, USA.
Kassim S; The Desmond Tutu HIV Centre, P.O Box 13801, Mowbray 7705, Cape Town, South Africa.
Naicker V; South Africa Medical Research Council, P.O Box 19070, Cape Town, South Africa.
Innes C; Aurum Institute, The Ridge, 29 Queens Road, Johannesburg, South Africa.
Naicker N; Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Private Bag X7, Durban, South Africa.
Dubula T; Walter Sisulu University, P. O Box 142, Eastern Cape, South Africa.
Grunenberg N; Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Malahleha M; Setshaba Research Centre, P.O Box 468, Pretoria, South Africa; Synergy Biomed Research Institute, 280 Oxford Street, East London 5201, South Africa.
Kublin JG; Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Bekker LG; The Desmond Tutu HIV Centre, P.O Box 13801, Mowbray 7705, Cape Town, South Africa.
Gray G; Perinatal HIV Research Unit, P.O Box 114, University of the Witwatersrand, South Africa.
Kumwenda J; Johns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi.
Laher F; Perinatal HIV Research Unit, P.O Box 114, University of the Witwatersrand, South Africa.

Vaccine ; 2024 May 21.

Article em En | MEDLINE | ID: mdl-38772835

ABSTRACT

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).