NCT03060629

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Efficacy Study of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-adjuvanted Clade C gp140 in Preventing HIV-1 Infection in Adult Women in Sub-Saharan Africa

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,636 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.

Conditions

• HIV-1

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.Mos4.HIV	Participants will receive Ad26.Mos4.HIV 5x10\^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12.
BIOLOGICAL	Clade C gp140	Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
BIOLOGICAL	Placebo	Participants will receive matching placebo.

Timeline

• Start date: 2017-11-03
• Primary completion: 2022-02-02
• Completion: 2022-02-02
• First posted: 2017-02-23
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

23 sites across 5 countries: Malawi, Mozambique, South Africa, Zambia, Zimbabwe

Regulatory

• FDA-regulated drug study