1
Participants
Start Date
February 20, 2019
Primary Completion Date
July 11, 2019
Study Completion Date
July 11, 2019
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."
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."
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.
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."
CHUV, Lausanne
Chelsea & Westminster Hospital, London
Collaborators (2)
European Commission
OTHER
Swiss Government
UNKNOWN
Medical Research Council
OTHER_GOV
FIT Biotech Ltd.
UNKNOWN
Fred Hutchinson Cancer Center
OTHER
University College, London
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Imperial College London
OTHER
"Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani IRCCS"
NETWORK
Universitätsklinikum Hamburg-Eppendorf
OTHER
Institut d'Investigacions Biomèdiques August Pi i Sunyer
OTHER
Henri Mondor University Hospital
OTHER
European Georges Pompidou Hospital
OTHER
Saint-Louis Hospital, Paris, France
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV