Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial

作者：Glenda Gray, Kathryn Mngadi, Ludo Lavreys, Steven Nijs, Peter B. Gilbert, John Hural, Ollivier Hyrien, Michal Juraska, Alex Luedtke, Philipp Mann, M. Juliana McElrath, Jackline Odhiambo, Daniel J Stieh, Janine van Duijn, Azwidihwi Takalani, Wouter Willems, Asa Tapley, Georgia D. Tomaras, Johan Van Hoof, Hanneke Schuitemaker, Edith Swann, Dan H. Barouch, James G. Kublin, Lawrence Corey, Maria Grazia Pau, Susan Buchbinder, Frank Tomaka, Jon J. Allagappen, Jessica Andriesen, Alison Ayres, Linda‐Gail Bekker, Caroline Borremans, William Brumskine, Roma Chilengi, Thozama Dubula, Nigel Garrett, Huub C. Gelderblom, Katherine Gill, Zaheer Hoosain, Mina C. Hosseinipour, Julia Hütter, Mubiana Inambao, Craig Innes, William Kilembe, Philippus Kotze, Sheena Kotze, Fatima Laher, László Imre, Erica Lazarus, Mookho Malahleha, Matsontso Mathebula, Mitch Matoga, Rachael McClennen, Pamela Mda, Peter Meerts, Vimla Naicker, Logashvari Naidoo, Tricia Philip, Annah Pitsi, Lorenz Scheppler, Carrie Sopher, Simbarashe Takuva, Edna Viegas, Mo Weijtens, Olive Yuan · 发表于：The Lancet Infectious Diseases · 年份：2024 · DOI：10.1016/s1473-3099(24)00358-x · 被引用次数：42 · 研究领域：HIV Research and Treatment、Cervical Cancer and HPV Research、Virology and Viral Diseases

BACKGROUND: HIV type 1 (HIV-1) remains a global health concern, with the greatest burden in sub-Saharan Africa. Despite 40 years of research, no vaccine candidate has shown durable and protective efficacy against HIV-1 acquisition. Although pre-exposure prophylaxis in groups with high vulnerability can be very effective, barriers to its use, such as perceived low acquisition risk, fear of stigma, and concerns about side-effects, remain. Thus, a population-based approach, such as an HIV-1 vaccine, is needed. The current study aimed to evaluate the efficacy and safety of a heterologous HIV-1 vaccine regimen, consisting of a tetravalent mosaic adenovirus 26-based vaccine (Ad26.Mos4.HIV) and aluminium phosphate-adjuvanted clade C glycoprotein (gp) 140, in young women at risk of acquiring HIV-1 in southern Africa. METHODS: This randomised, double-blind, phase 2b study enrolled sexually active women without HIV-1 or HIV-2 aged 18-35 years at 23 clinical research sites in Malawi, Mozambique, South Africa, Zambia, and Zimbabwe. Participants were centrally randomly assigned (1:1) to receive intramuscular injections of vaccine or saline placebo in stratified permuted blocks via an interactive web response system. Study participants, study site personnel (except those with primary responsibility for study vaccine preparation and dispensing), and investigators were masked to treatment group allocation. The vaccine regimen consisted of Ad26.Mos4.HIV administered at months 0 and 3 followed...