EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/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
Can a therapeutic vaccination and monoclonal antibody treatment improve control of HIV replication?
What is this study about?
The main objective of the study is to assess how well vedolizumab (a drug currently used to treat ulcerative colitis) and a vaccine called MVA can control HIV. All participants will have started treatment since 2009, will have been on treatment for at least one year and will be virologically suppressed.
This international, phase II, double-blind study planned to evaluate two experimental arms, each compared to placebo control, in participants living with HIV-1 to see if either has a clinically relevant impact on viral replication.
Participants are randomised equally across three groups, to receive either:
- MVA vaccine and infusion with vedolizumab
- Placebo vaccine and infusion with vedolizumab
- Placebo vaccine and placebo infusions.
Type of study
Who is funding the study?
The trial is funded by the European Commission Horizon 2020 Research and Innovation Programme (Grant no. 681032); Swiss State Secretariat for Education, Research and Innovation (SERI) (Grant no. 15.0337); and the Vaccine Research Institute/Inserm-ANRS.
When is it taking place?
The trial opened in July 2019 and follow-up is ongoing.
Where is it taking place?
Hospital clinics in the United Kingdom, France, Switzerland and Germany.
Who is included?
HIV-positive participants who:
• started HIV treatment after 2009
• started their treatment at least one year ago
• are willing to stop antiretroviral treatment for a short time or change treatment if required.