1,512
Participants
Start Date
December 15, 2020
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48)
"1. DNA-HIV-PT123 HIV vaccine includes three DNA plasmids that encode clade C ZM96 Gag, clade C ZM96 Env, and CN54 Pol-Nef.~2. AIDSVAX® B/E is a bivalent HIV gp120 glycoprotein encompassing both subtype B (MN) and subtype E (A244) proteins that are adsorbed onto 600mcg of aluminum hydroxide gel suspension as adjuvant."
Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48)
"1. DNA-HIV-PT123 (see above)~2. CN54gp140+MPLA-L. Recombinant CN54gp140 is a HIV-1 envelope protein from the clade C strain 97/CN/54 isolate, which comprises a sequence of 634 amino acids. MPLA is a non-toxic version of LipoPolySaccharide (LPS), which is isolated from the LPS lipid A region of Salmonella Minnesota R595 and retains the immune-stimulatory properties of LPS, but exhibits low toxicity.~3. MVA-CMDR (Modified Vaccinia Ankara-Chiang Mai Double Recombinant) is a non-replicating, highly attenuated strain of Vaccina virus that has been genetically engineered to express the HIV-1 genes envgp160 CM235 Subtype E and gag and pol CM240 Subtype A (integrase-deleted and reverse transcriptase non-functional)."
Vaccine Group C: Saline placebo (weeks 0,4,24,48)
Sodium Chloride (NaCl) for injection, 0.9%
Control PrEP:TDF/FTC once daily (weeks 0-26)
Each tablet of Truvada contains 245mg of tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC), both of which are nucleot/side analogue HIV-1 reverse transcriptase inhibitors.
Experimental PrEP:TAF/FTC once daily (weeks 0-26)
Each tablet of Descovy contains 25mg of tenofovir alfenamide (TAF) and 200mg of emtricitabine (FTC), both of which are nucleot/side analogue HIV-1 reverse transcriptase inhibitors.
MRC/UVRI and LSHTM Uganda Research Unit, Entebbe
Collaborators (1)
Imperial College London
OTHER
University College, London
OTHER
International AIDS Vaccine Initiative
NETWORK
EuroVacc Foundation
OTHER
Medical Research Council, South Africa
OTHER
National Institute for Medical Research, Tanzania
OTHER_GOV
Muhimbili University of Health and Allied Sciences
OTHER
Instituto Nacional de Saúde, Mozambique
OTHER_GOV
Ludwig-Maximilians - University of Munich
OTHER
King's College London
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Karolinska Institutet
OTHER
CONRAD
OTHER
Gilead Sciences
INDUSTRY
MRC/UVRI and LSHTM Uganda Research Unit
OTHER