A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection (EHVA T02)

Summary

EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.

Conditions

• HIV-1-infection

Interventions

BIOLOGICAL

Vaccine and vedolizumab (Entyvio)

Vaccine and vedolizumab infusion (Entyvio): 0.5ml of MVA HIV-B (1 x 108 pfu/ml) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection. Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion.

BIOLOGICAL

Placebo vaccine and vedolizumab infusion (Entyvio)

Placebo Vaccine: The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection. Vedolizumab infusion (Entyvio): Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion.

BIOLOGICAL

Placebo vaccine and placebo infusion

Placebo Vaccine: The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection. Placebo infusion (Entyvio): 255ml Sodium Chloride (NaCl) 0.9% bag administered as an intravenous infusion over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. Participants will be observed throughout and after the infusion.

Sponsors & Collaborators

• EuroVacc Foundation

  collaborator OTHER

• European AIDS Treatment Group (EATG)

  collaborator UNKNOWN

• Medical Research Council

  collaborator OTHER_GOV

• University College London Hospitals

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• European Georges Pompidou Hospital

  collaborator OTHER

• Saint-Louis Hospital, Paris, France

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois

  collaborator OTHER

• Chelsea and Westminster Hospital, UK

  collaborator UNKNOWN

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

  collaborator NETWORK

• Imperial College London

  collaborator OTHER

• Institut d'Investigacions Biomèdiques August Pi i Sunyer

  collaborator OTHER

• European Commission

  collaborator OTHER

• Swiss Government

  collaborator UNKNOWN

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Yves Levy, MD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-21

Primary Completion

2023-07-12

Completion

2023-07-12

Countries

• France
• Switzerland
• United Kingdom

Study Locations