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HPX2008/ HVTN 705

Status
Ongoing
Phase
IIb
Objective

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 gp140 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.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 gp140 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.

 

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Participants will receive Ad26.Mos4.HIV 5*10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 [microgram] mcg) co-formulated with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Mode of Delivery
Intramuscular
Products
Ad26.Mos.HIV
gp140
ARMs
Experimental
Clade
C
Description
Participants will receive Placebo for Ad26.Mos4.HIV as 0.5 mL into the left deltoid on Months 0, 3, 6, and 12 and Placebo for Clade C gp140 / Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
Janssen Vaccines & Prevention B.V.
November 2017
September 2021
Enrollment
2 600
18
Years
35
Years
Population
Women
Sites

UNC Lilongwe CRS

Lilongwe
Malawi

Centro de Investigação e Treino em Saúde de Polana Caniço

Maputo
Mozambique

Josha Research Center

Josha, Bloemfontein
South Africa

Madibeng Centre for Research

Brits
South Africa

Emavundleni Desmond Tutu HIV Centre CRS

Cape Town
South Africa

University of Cape Town

Cape Town
South Africa

Desmond Tutu HIV Foundation - Masiphumelele

Masiphumelele
South Africa

Ndlovu Medical Centre

Limpopo
South Africa

Perinatal HIV Research Unit

Soweto
South Africa

The Aurum Institute

Rustenburg
South Africa

Qhakaza Mbokodo Research Clinic

Ladysmith
South Africa

Chatsworth CRS

Chatsworth, KwaZulu-Natal
South Africa

CAPRISA Kwazulu-Natal

South Africa

South African Med Research Council - Isipingo

Durban
South Africa

South African Med Research Council - Verulam

Durban
South Africa

South African Med Research Council - Tongaat

Durban
South Africa

Stanza Clinical Research Centre- Mamelodi

City of Tshwane Metropolitan Municipality
South Africa

Site(s) - Mthatha

South Africa

MeCRU CRS

Pretoria
South Africa

Rustenburg CRS

Rustenburg
South Africa

Setshaba Research Centre

Shoshanguve
South Africa

Kliptown

Soweto
South Africa

The Aurum Institute, Tembisa Hospital

Tembisa
South Africa

Matero Reference Clinic CRS

Lusaka
Zambia

Zambia Emory HIV Research Project (Ndola)

Ndola
Zambia

UZ-UCSF HIV Prevention Trials Unit - Seke South

Chitungwiza
Zimbabwe