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COMPLETED
NCT04844775
PHASE1

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

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

EHVA P01 is an international, phase I, 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.

Official title: EHVA P01/ANRS VRI08: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2022-08-05

Completion Date

2024-09-09

Last Updated

2026-06-08

Healthy Volunteers

Yes

Conditions

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 It is an alphavirus-based DNA replicon in which the sequences coding for the viral capsid and envelope have been replaced by the sequences encoding HIV-1 gp140 (96ZM651) antigen. 2.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.

Locations (4)

CIC Cochin

Paris, Paris Cedex 14, France

Hôpital Henri Mondor

Créteil, Paris, France

CHUV

Lausanne, Canton of Vaud, Switzerland

Chelsea and Westminster Hospital

London, United Kingdom