- Source : Press Release
- Date : 2018-11-27
- Event type : Phase 2
- Companies : FIT Biotech Oy
European HIV Vaccine Alliance (EHVA) Initiates a Clinical Trial to Test a Novel Therapeutic Vaccine and Immunotherapy Drug
The European HIV Vaccine Alliance (EHVA) announces the start of the EHVA T01 / ANRS VRI05 trial, with the initiation of screening of participants at the Lausanne University Hospital Switzerland. EHVA-T01 / ANRS VRI05, a phase I/II placebo-controlled randomised trial, will evaluate an experimental therapeutic HIV vaccine and an experimental immunotherapy drug in people living with HIV across six countries in Europe.
The vaccine candidate is a prime-boost combination of a DNA and an MVA-based vaccine. The DNA vaccine, GTU-MultiHIV B-clade DNA, was developed by FIT Biotech (an EHVA partner), and comprises multiple components of genetic information of HIV Clade B. The MVA vaccine, MVA HIV-B, was developed by ANRS, and contains genetic sequences of the HIV Clade B genes gag, pol and nef, within a viral vector based on Modified Vaccinia Virus Ankara (MVA).
The DNA-MVA vaccine regimen will be evaluated in combination with the monoclonal antibody Vedolizumab. This antibody binds to and blocks the integrin α₄β₇ and is licensed for use in the treatment of ulcerative colitis and Crohn's disease.
The trial will evaluate if the vaccine candidate and immunotherapy drug alone or in combination can control viral replication, following analytic treatment interruption, in individuals who started antiretroviral therapy during primary or chronic infection. The trial will address the hypothesis that a therapeutic vaccine in combination with Vedolizumab exerts a synergistic effect on controlling HIV replication, by protecting CD4+ T-cells from infection and enhancing immune responses targeting HIV.
EHVA-T01/ ANRS VRI05 is sponsored by Inserm-ANRS, an autonomous agency of the French National Institute of Health and Medical Research in the field of HIV and hepatitis research and managed by The Medical Research Council Clinical Trials Unit at University College London. The trial has received full regulatory and ethics approval in Switzerland and the UK. Participating clinical trial research centers include the Lausanne University Hospital (CHUV), with EuroVacc as the Swiss sponsor representative, and the Chelsea and Westminster Hospital, as part of Imperial College London. Requests for approvals have been submitted in four additional countries, with the planned participation of six additional research centers. EHVA member institutions will provide immunological and statistical analyses, as well as data management, data analysis and pharmacovigilance.
The trial is funded by the European HIV Vaccine Alliance as part of a 5-year grant from the European Union’s Horizon 2020 Research and Innovation Programme (grant agreement no. 681032), and the Swiss government (through the State Secretariat for Education, Research and Innovation, SERI under grant agreement no. 15.0337). The trial receives additional funding from the Vaccine Research Institute and Inserm-ANRS.