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Active Studies

Protocol VAC89220HPX3002

Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of a heterologous vaccination regime with Ad26.Mos4.HIV and the combination of adjuvanted Clate C gp140 and Mosaic gp140 to prevent infection by HIV-1 among cisgender men and transgender individuals who have sex with cisgender men and / or transgender individuals.
Summary of study: The objective of this study is to demonstrate the efficacy of a heterologous vaccination regime for the prevention of human immunodeficiency virus type 1 (HIV-1) infection consisting of Ad26.Mos4.HIV and a combination of glycoprotein (gp) from Clade C 140 and Mosaic gp140 (gp140 Mos), adjuvated with aluminum phosphate. The study population will include healthy adults who are considered to be at higher risk of acquiring HIV-1 infection. The expected number is 3,800 participants, consisting of HIV-1 uninfected persons, specifically cisgender men and transgender individuals who have sex with cisgender men and / or transgender individuals, aged ≥ 18 to ≤60 years, will be randomized in a proportion 1: 1 to receive study vaccine or placebo.

Study News

The previously planned analysis of the study results clearly shows that the number of people who have become infected with HIV is very similar in both arms of the study (vaccine or placebo), therefore it has NOT been possible to demonstrate the efficacy of this vaccine to prevent HIV infection.

For this reason, the independent Committee that periodically evaluates the data of the study (DSMB) has recommended us, the investigators and the sponsor, to stop the study, since these findings are consistent and it is not possible that they will be modified with more follow-up time. On the other hand, the vaccine proved to be safe, that is, it was not associated with significant adverse effects.

Once again, we want to thank the commitment and effort of the participants in this research, our respect and admiration for them, together with our commitment to continue monitoring them if they consider it so. A special recognition to the Community team, to the ClinSex and Emerging Diseases team of the JM Ramos Mejia Hospital; and each one of the members of the CICAL team, for their commitment and hard work of excellence to make this study possible.

Official communiqués of HVTN network and Johnson & Johnson:



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COVPN 5001


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