An HIV Vaccine Trial in Individuals Who Started ART During Primary or Chronic Infection

Summary

EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants to see if one or more has a clinically relevant impact on the control of viral replication.

Conditions

• HIV-1-infection

Interventions

BIOLOGICAL

GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine

The vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0). 0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection.

BIOLOGICAL

GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab

The vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0). 0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection. Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline.

DRUG

Vedolizumab 300 MG [Entyvio]

Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline.

OTHER

Placebo

Placebo for MVA it is a solution composed of S08 buffer (as for the MVA vaccine) that will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection. Placebo for GTU-MultiHIV B-clade vaccine: Sodium Chloride (NaCl) for infusion, 0.9%. Placebo for Vedolizumab: Sodium Chloride (NaCl) for infusion, 0.9% in 250 ml infusion bags.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Swiss Government

  collaborator UNKNOWN

• Medical Research Council

  collaborator OTHER_GOV

• FIT Biotech Ltd.

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  collaborator OTHER

• University College, London

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois

  collaborator OTHER

• Imperial College London

  collaborator OTHER

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

  collaborator NETWORK

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Institut d'Investigacions Biomèdiques August Pi i Sunyer

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• European Georges Pompidou Hospital

  collaborator OTHER

• Saint-Louis Hospital, Paris, France

  collaborator OTHER

• 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

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-20

Primary Completion

2019-07-11

Completion

2019-07-11

Countries

• Switzerland
• United Kingdom

Study Locations