A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection (EHVA T02)
Condition: HIV-1-infection
MeSH terms: Infections; Communicable Diseases; Persistent Infection
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Screening will take place during the 6 weeks prior to randomisation. Eligible participants
      will be enrolled at week 0 and randomised to MVA HIV-B vaccine followed by vedolizumab,
      vedolizumab + placebo vaccine, or placebo vaccine + placebo infusions.

      Participants will be randomised at each centre through web-based randomisation after entering
      the eligibility criteria. There will be two strata: one for those who started treatment
      during primary infection, and one for those who started treatment during chronic infection.

      69 eligible individuals from collaborating European Countries will be enrolled, aiming for
      approximately half who started cART in primary infection and half who started in chronic
      infection. Participants continue from the screening visit (up to 6 weeks before enrolment) to
      the last visit, a maximum of 60 weeks (around 14 months), although follow-up will continue
      through to the time when virus is fully suppressed.

      Treatment will be interrupted at week 18 and resumed when the viral load is confirmed to have
      rebounded to ≥100,000 copies/ml, or the CD4 falls to ≤350 cells/mm3, confirmed, or there is
      evidence of disease progression, or they have completed 24 weeks of treatment interruption.
    

Intervention name(s): Vaccine and vedolizumab (Entyvio); Placebo vaccine and vedolizumab infusion (Entyvio); Placebo vaccine and placebo infusion
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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:
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:
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.
Intervention MeSH terms: Vedolizumab; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment