A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP

PHASE2CompletedINTERVENTIONAL
Enrollment

1,512

Participants

Timeline

Start Date

December 15, 2020

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
HIV Infections
Interventions
BIOLOGICAL

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."

BIOLOGICAL

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)."

BIOLOGICAL

Vaccine Group C: Saline placebo (weeks 0,4,24,48)

Sodium Chloride (NaCl) for injection, 0.9%

DRUG

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.

DRUG

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.

Trial Locations (1)

Unknown

MRC/UVRI and LSHTM Uganda Research Unit, Entebbe

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Imperial College London

OTHER

collaborator

University College, London

OTHER

collaborator

International AIDS Vaccine Initiative

NETWORK

collaborator

EuroVacc Foundation

OTHER

collaborator

Medical Research Council, South Africa

OTHER

collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

collaborator

Muhimbili University of Health and Allied Sciences

OTHER

collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

collaborator

Ludwig-Maximilians - University of Munich

OTHER

collaborator

King's College London

OTHER

collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

collaborator

Karolinska Institutet

OTHER

collaborator

CONRAD

OTHER

collaborator

Gilead Sciences

INDUSTRY

lead

MRC/UVRI and LSHTM Uganda Research Unit

OTHER