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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
Official Code
Related Publications
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