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

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.

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 It is an alphavirus-based DNA replicon in which the sequences coding for the viral capsid and envelope have been replaced by the sequences encoding HIV-1 gp140 (96ZM651) antigen. 2.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

Sponsors & Collaborators

• Medical Research Council

  collaborator OTHER_GOV

• Henri Mondor University Hospital

  collaborator OTHER

• Chelsea and Westminster Hospital, UK

  collaborator UNKNOWN

• EuroVacc Foundation

  collaborator OTHER

• European Commission

  collaborator OTHER

• Swiss Government

  collaborator UNKNOWN

• University College London Hospitals

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

  collaborator OTHER

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-05

Primary Completion

2024-09-09

Completion

2024-09-09

Countries

• France
• Switzerland
• United Kingdom

Study Locations