INSERM. France: A clinical trial project, coordinated by Inserm, involving the
testing of a preventive vaccine against Ebola has been selected by the
European Commission. The protocol plans to include 1,500 participants
throughout Europe and Africa to evaluate immune response and tolerance
to a vaccine strategy named “prime boost”, based on the use of two
candidate vaccines developed by the Janssen company.
The development and rapid access to treatment and candidate vaccines
are among recommendations made by WHO to stop the transmission of the
Ebola virus and prevent the international spread of infection. Since the
beginning of the epidemic, the French and international scientific
community has mobilised to meet these objectives.
In this respect, Inserm has established an academic partnership with
the London School of Hygiene and Tropical Medicine (LSHTM), as well as
an industrial partnership (Crucell Holland BV; Janssen) to develop a
vaccination from Phase 1 to Phase 3 that combines two vaccines derived
from viral vectors (Ad26.ZEBOV et MVA-BN-Filo[1]).
This project has been selected for funding by the European Commission
under the second call for IMI2 (Innovative Medicines Initiative)
projects. As part of this programme, Inserm will conduct Phase 2 trials
in England and France, as well as the Muraz Centre in Burkina Faso and
other centres throughout Africa (Ivory Coast to Abidjan and East Africa )
under the coordination of Professor Rodolphe Thiébaut.
Phase 2 trials (EBOVAC 2 project) will involve 1,500 volunteers.
These trials will evaluate the tolerance and quality of immune response
to the vaccine strategy. These tests will supplement data from Phase 1
trials that are currently in progress in the United States, England and
Tanzania, which will be available in March 2015 and will be critical to
evaluating effectiveness in areas at risk.
“This strategy, unlike conventional immunization protocols that
involve one or more administrations of the same vaccine, is based on the
concept of a vaccination involving several steps with two different
vectors that will expose the organism to the same antigens in several
ways. This is a new approach in the development of a vaccine against
Ebola” stated Prof. Yves Levy, Inserm CEO.
This project has received funding from Innovative Medicines
Initiative 2 and support from the H2020 research and innovation
programme by the European Union and EFPIA.
[1]
Both of the viral vectors used are conventional vectors that are
already widely used in humans in several vaccines for other infectious
diseases.