The main objective of the trial is to evaluate if an experimental 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. The trial will evaluate if the immunotherapy drug alone or in combination with the vaccine candidate can control viral replication, following interruption of antiretroviral treatment in individuals who started antiretroviral therapy during primary or chronic infection.
The vaccine candidate being evaluated in EHVA T02 / ANRS VR017 is MVA HIV-B, which 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 Ankara (MVA). MVA HIV-B will be evaluated in combination with the monoclonal antibody vedolizumab, which is licensed for use in the treatment of ulcerative colitis and Crohn’s disease. As an investigational HIV drug, vedolizumab is being researched for its potential to impede HIV replication by blocking the integrin α4β7, an important receptor on CD4+ T-cells.
In light of the COVID-19 pandemic, the EHVA team had to postpone the start of the trial for close to a year, firstly during the initial waves of the pandemic, and more recently to ensure that those interested in participating in the trial have had the opportunity to complete their COVID-19 vaccination. During this time, the EHVA clinical team worked closely with the community of people living with HIV through its partner the European AIDS Treatment Group in the planning of the trial, including developing appropriate safeguarding measures and information support for trial participants.
EHVA-T02/ ANRS VRI07 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 first trial participant has been enrolled in Switzerland, at the Lausanne University Hospital (CHUV), with EuroVacc as the Swiss sponsor representative. Full regulatory and ethics approval has been secured in the UK and France. In the UK, the trial will be conducted at the Chelsea and Westminster Hospital; in France, at the Henri Mondor Hospital, Hotel Dieu de Paris Hospital and Saint Louis Hospital. In Germany, where the trial will be conducted at the Universitätsklinikum in Hamburg, regulatory approval has been received and ethics review is in its final stages.
The European AIDS Treatment Group will serve as the community engagement partner. Other 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.
The European HIV Alliance (EHVA) is a 5-year project funded by the European Union’s Horizon 2020 Research and Innovation Programme and the Swiss government and designed to foster the development of an effective vaccine to prevent HIV infection and AIDS. The Alliance encompasses 41 academic, non-profit, community and industry partners from across Europe, as well as partners from sub-Saharan Africa and North America. The multidisciplinary team encompasses all aspects of vaccine development from early-stage discovery to clinical trials, and its work will build on the latest advances in preclinical and clinical vaccine development.
For more information about the EHVA and its partners, please visit: www.ehv-a.eu
For more information about the trial, please visit: https://clinicaltrials.gov/ct2/show/NCT04120415
Source : EHVA
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