EHVA T02(European HIV Vaccine Alliance Therapeutic Trial02)/ANRS VRI07
Research type
Research Study
Full title
EHVA T02(European HIV Vaccine Alliance Therapeutic Trial02)/ANRS VRI07: A Phase II randomised, placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine in individuals who started antiretrovirals during primary or chronic infection
IRAS ID
271301
Contact name
Marta Boffito
Contact email
Sponsor organisation
Inserm-ANRS
Eudract number
2019-002818-40
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Antiretroviral HIV treatment (ART) has transformed the survival of people living with HIV. However, ART is life long and there are a number of limitations to the benefits of taking it. The drugs do not cure HIV, they may be associated with side-effects, and some people may find it difficult to take a drug every day for the rest of their life.
The development of other approaches to help their immune system control and overcome the HIV virus is a key goal. We believe that therapeutic vaccination has a role to play in this.
Another approach is the use of monoclonal antibodies as immunotherapy, i.e. a treatment that improves your immune system.
This study will measure:
•the impact of a vaccine (MVA) on viral load
•the impact of immunotherapy (Vedolizumab – a monoclonal antibody) on viral load
•the impact of combining the vaccine with immunotherapy on viral load.
To measure the impact of these strategies on viral load, we need to ask people in the study to stop HIV treatment for up to 24 weeks.
We are looking to recruit patients in the UK and 5 other European countries who are HIV positive and stable on their current therapy. Participants will be in the study for up to 60 weeks and will receive:
1)active vaccine and active monoclonal antibody infusion,
2)placebo vaccine and active monoclonal antibody infusion or
3)placebo vaccine and placebo infusion.
The study is funded under a grant from the European Union’s Horizon 2020 Research and Innovation Programme and also by a grant from the Swiss government.LAY SUMMARY OF STUDY RESULTS:
The EHVA T02 trial planned to enrol 69 participants in order to obtain meaningful results. By October 2022 only two participants had been enrolled in the trial in Switzerland and the UK and it was clear that the intensity of the schedule and length of the intervention visits were disincentives and the trial was not going to achieve the necessary number of participants. The decision was taken to end the trial activities before any participants took the risk of interrupting their treatment and participants and authorities in each participating country were informed. The participants were followed up to collect safety data through to 18 weeks after the last trial intervention.
REC name
London - South East Research Ethics Committee
REC reference
19/LO/1573
Date of REC Opinion
4 Nov 2019
REC opinion
Favourable Opinion