Section: Partnerships and Cooperations

European Initiatives

FP7 & H2020 Projects

The member of SISTM Team are involved in EHVA (European HIV Vaccine Alliance):

• Program: Most information about this program can be found at http://www.ehv-a.eu.

• Coordinator: Rodolphe Thiébaut is Work Package leader of the WP10 "Data Integration".

• Other partners: The EHVA encompasses 39 partners, each with the expertise to promote a comprehensive approach to the development of an effective HIV vaccine. The international alliance, which includes academic and industrial research partners from all over Europe, as well as sub-Saharan Africa and North America, will work to discover and progress novel vaccine candidates through the clinic.

• Abstract: With 37 million people living with HIV worldwide, and over 2 million new infections diagnosed each year, an effective vaccine is regarded as the most potent public health strategy for addressing the pandemic. Despite the many advances in the understanding, treatment and prevention of HIV made over the past 30 years, the development of broadly-effective HIV vaccine has remained unachievable. EHVA plans to develop and implement:

  Discovery Platform with the goal of generating novel vaccine candidates inducing potent neutralizing and non-neutralizing antibody responses and T-cell responses

  Immune Profiling Platform with the goal of ranking novel and existing (benchmark) vaccine candidates on the basis of the immune profile

  Data Management/Integration/Down-Selection Platform, with the goal of providing statistical tools for the analysis and interpretation of complex data and algorithms for the efficient selection of vaccines

  Clinical Trials Platform with the goal of accelerating the clinical development of novel vaccines and the early prediction of vaccine failure.

Collaborations in European Programs, Except FP7 & H2020

• Program: The EBOVAC2 project is one of 8 projects funded under IMI Ebola+ programme that was launched in response to the Ebola virus disease outbreak. The project aims to assess the safety and efficacy of a novel prime boost preventive vaccine regimen against Ebola Virus Disease (EVD). Project acronym: EBOVAC2 Project title: EBOVAC2 Coordinator: Rodolphe Thiébaut Other partners: Inserm (France), Labex VRI (France), Janssen Pharmaceutical Companies of Johnson & Johnson, London School of Hygiene & Tropical Medicine (United Kingdom), The Chancellor, Masters and Scholars of the University of Oxford (United Kingdom), Le Centre Muraz (Burknia Faso), Inserm Transfert (France) Given the urgent need for an preventive Ebola vaccine strategy in the context of the current epidemic, the clinical development plan follows an expedited scheme, aiming at starting a Phase 2B large scale safety and immunogenicity study as soon as possible while assuring the safety of the trial participants.

  Phase 1 trials to assess the safety and immunogenicity data of the candidate prime-boost regimen in healthy volunteers are ongoing in the UK, the US and Kenya and Uganda. A further study site has been approved to start in Tanzania. Both prime-boost combinations (Ad26.ZEBOV prime + MVA-BN-Filo boost; and MVA-BN-Filo prime + Ad26.ZEBOV boost) administered at different intervals are being tested in these trials.

  Phase 2 trials (this project) are planned to start as soon as the post-prime safety and immunogenicity data from the UK Phase I are available. Phase 2 trials will be conducted in healthy volunteers in Europe (France and UK) and non-epidemic African countries (to be determined). HIV positive adults will also be vaccinated in African countries. The rationale for inclusion of European volunteers in Phase 2, in addition to the trials in Africa, is to allow for higher sensitivity in safety signal detection in populations with low incidence of febrile illnesses, to generate negative control specimens for assay development, to allow for inclusion of health care workers or military personnel that may be deployed to Ebola-endemic regions.

• EBOVAC3 As a follow-up project, the IMI-2 funded EBOVAC3 project, has started in 2018. In this project, the vaccine strategy will be further evaluated in specific populations in Africa (infants in Guinea and Sierra Leone; and front line workers in RDC). The project includes a work package on modelling, which is led by Rodolphe Thiebaut.

Collaborations with Major European Organizations

• University of Oxford;

• London School of Hygiene and Tropical Medicine;

• University Hospital Hamburg;

• Heinrich Pette Institute for Experimental Virology, Hambourg;

• MRC, University College London;

• MRC Biostatistics Unit, University of Cambridge.