common.study.topics.clinical

HIV Vaccine and Transgender Individuals

common.study.values.description

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

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.

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participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

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common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Biological - Ad26.Mos4.HIV

Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.

Biological - Clade C and Mosaic gp140 HIV bivalent vaccine

Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.

Biological - Placebo

Participants will receive matching placebo.

participant.views.study.view.additional

participant.views.study.view.scientific-title

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and 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

common.study.values.clinical-trial-id

NCT03964415

participant.views.study.view.id

eERpWa