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?
This international, phase II, double-blind study will 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. The study aims to randomise 69 eligible individuals across European collaborating countries.
The main objective of the study will be to assess the impact of vedolizumab and vaccination with MVA upon viral control following analytic treatment interruption (ATI). The study will be a three-arm, 1:1:1 randomisation. All participants will have started treatment since 2009, will have been on treatment for at least one year and be virologically suppressed. Participants will be randomised to MVA HIV-B vaccine followed by vedolizumab, vedolizumab + placebo vaccines, or placebo vaccines + placebo infusions.
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.
Type of study
Who is funding the study?
- European Commission Horizon 2020 Research and Innovation Programme (Grant no. 681032)
- Swiss State Secretariat for Education, Research and Innovation (SERI) (Grant no. 15.0337)
- Vaccine Research Institute/Inserm-ANRS
When is it taking place?
December 2021 – June 2023
Where is it taking place?
Hospital clinics in the United Kingdom, France, Switzerland, Germany, Italy and Spain
Who is included?
HIV positive participants who started HIV treatment after 2009 and at least one year ago, and are willing to stop antiretroviral treatment for a short time or change treatment if required.