2
Participants
Start Date
June 21, 2022
Primary Completion Date
July 12, 2023
Study Completion Date
July 12, 2023
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."
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."
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."
Centre d'Immunothérapie et Vaccinologie, CHUV, Lausanne
Hotel Dieu, Paris
Service Immunologie clinique et maladies infectieuses, Hôpital Henri Mondor, Paris
St Stephens Centre, Chelsea & Westminster Hospital, London
Collaborators (2)
EuroVacc Foundation
OTHER
European AIDS Treatment Group (EATG)
UNKNOWN
Medical Research Council
OTHER_GOV
University College London Hospitals
OTHER
University of Liverpool
OTHER
Erasmus Medical Center
OTHER
Henri Mondor University Hospital
OTHER
European Georges Pompidou Hospital
OTHER
Saint-Louis Hospital, Paris, France
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Chelsea and Westminster Hospital, UK
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf
OTHER
Hospital Clinic of Barcelona
OTHER
"Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani IRCCS"
NETWORK
Imperial College London
OTHER
Institut d'Investigacions Biomèdiques August Pi i Sunyer
OTHER
European Commission
OTHER
Swiss Government
UNKNOWN
ANRS, Emerging Infectious Diseases
OTHER_GOV