A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

August 5, 2022

Primary Completion Date

September 9, 2024

Study Completion Date

September 9, 2024

Conditions
Healthy Adults
Interventions
BIOLOGICAL

Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L

"1. Drep-HIV-PT1 The DREP-HIV-PT1 is a vaccine designed to elicit an immune response against human immunodeficiency virus-1 (HIV-1) and prevent infection by HIV-1 and/or disease caused by HIV-1. It is an alphavirus-based DNA replicon in which the sequences coding for the viral capsid and envelope have been replaced by the sequences encoding HIV-1 gp140 (96ZM651) antigen.~2.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."

BIOLOGICAL

DREP-HIV-PT1 1mg and CN54gp140/MPLA-L (see above)

"1. Drep-HIV-PT1 1mg (see above)~2. Drep-HIV-PT1 1mg (see above)"

BIOLOGICAL

DNA-HIV-PT123 4mg and CN54gp140/MPLA-L

"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. 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."

Trial Locations (4)

1011

CHUV, Lausanne

75679

CIC Cochin, Paris

94010

Hôpital Henri Mondor, Créteil

SW10 9NH

Chelsea and Westminster Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical Research Council

OTHER_GOV

collaborator

Henri Mondor University Hospital

OTHER

collaborator

Chelsea and Westminster Hospital, UK

UNKNOWN

collaborator

EuroVacc Foundation

OTHER

collaborator

European Commission

OTHER

collaborator

Swiss Government

UNKNOWN

collaborator

University College London Hospitals

OTHER

collaborator

Imperial College London

OTHER

collaborator

Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

OTHER

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT04844775 - A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults | Biotech Hunter | Biotech Hunter