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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

February 20, 2019

Primary Completion Date

July 11, 2019

Study Completion Date

July 11, 2019

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."

Trial Locations (2)

1011

CHUV, Lausanne

SW10 9NH

Chelsea & Westminster Hospital, London

All Listed Sponsors
collaborator

European Commission

OTHER

collaborator

Swiss Government

UNKNOWN

collaborator

Medical Research Council

OTHER_GOV

collaborator

FIT Biotech Ltd.

UNKNOWN

collaborator

Fred Hutchinson Cancer Center

OTHER

collaborator

University College, London

OTHER

collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

collaborator

Imperial College London

OTHER

collaborator

"Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani IRCCS"

NETWORK

collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

collaborator

Henri Mondor University Hospital

OTHER

collaborator

European Georges Pompidou Hospital

OTHER

collaborator

Saint-Louis Hospital, Paris, France

OTHER

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV