A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals

Phase 3 Completed 3900 enrolled Janssen Vaccines & Prevention B.V.

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.

Timeline

Start: 2019-10-31
Primary completion: 2023-08-10
Completion: 2023-08-10

Outcome

Missed primary endpoint

paper with an estimated vaccine efficacy (months 7-24) of -0·7% (95% CI -50·9 to 32·8; p=0·97). PMID 41314741 ↗

paper The lack of efficacy in this and other HIV vaccine trials points to the importance of current efforts to develop vaccines that generate broadly neutralising antibodies. PMID 41314741 ↗

Publications

Buchbinder SP, Spinosa Guzman S, Sanchez J, Willems W, Stieh DJ, van Duijn J, van Rosmalen MGM, Hendriks J, Nijs S, Lavreys L, Paez CA, Grinzstejn B, Hutter J, Mann P, Sierra Madero JG, Cahn P, Castagna A, Truyers C, Roels S, Gilbert PB, Carone M, Luedtke A, Corey L, Pau MG, Tomaka F; HVTN 706/HPX3002/Mosaico Study Team. Efficacy and safety of a mosaic HIV-1 vaccine regimen in men who have sex with men and transgender individuals (HVTN 706/HPX3002/Mosaico): a global, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2025 Dec;12(12):e823-e835. doi: 10.1016/S2352-3018(25)00195-X.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.Mos4.HIV	Vaccine	—	Intramuscular
Subject	Clade C and Mosaic gp140 HIV bivalent vaccine	Vaccine	—	Intramuscular

Indications

No indication recorded.