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HVTN 705 / HPX2008 / CR108263/ Imbokodo

Status
Completed
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. 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.

Result: An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data (NIH, 2021). The vaccine may have shown superior protection in participants aged 31-35, but the numbers are too small to draw firm conclusions (TAG Pipeline Report, 2022).

Last updated September 13, 2022.

Prevention Option(s)
HIV Vaccine
Study Design
Placebo-controlled
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/Mosaic
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., HVTN, NIAID, SAMRC, US Army Medical Research and Development Command, Ragon Institute
November 2017
July 2022
Enrollment
2 637
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

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

Setshaba Research Centre

Shoshanguve
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

Perinatal HIV Research Unit

Soweto
South Africa