Ebola: New trial launched in West Africa to evaluate three vaccination strategies
The French National Institute of Health and Medical Research (Inserm), the US National Institutes of Health (NIH) and the London School of Hygiene & Tropical Medicine (LSHTM), in collaboration with health authorities in Guinea and Liberia, are launching a large clinical trial of candidate Ebola vaccines under the aegis of the PREVAC international consortium (Partnership for Research on Ebola VACcination).
PREVAC in brief
PREVAC (Partnership for Research on Ebola VACcination), is a research consortium that brings together the health authorities of three countries in West Africa--Guinea, Liberia and Sierra Leone--and their international partners, the National Institute of Health and Medical Research (Inserm) in France, the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID/NIH) in the United States, and the London School of Hygiene & Tropical Medicine (LSHTM) in the United Kingdom. Additional partners in the consortium include the NGO field partner Alliance for International Medical Action (ALIMA). The pharmaceutical companies Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Bavarian Nordic and Merck Sharp & Dohme, Corp (MSD outside USA and Canada), are supplying the experimental vaccines being tested in the PREVAC trial.
The PREVAC trial is a Phase 2 clinical trial being conducted in West Africa. It is a randomised trial that aims to compare three experimental Ebola vaccination strategies with placebos in order to determine whether these strategies are safe and able to trigger a durable immune response that can protect against Ebola virus disease. In the first stage, the trial intends to enrol up to 600 participants 12 years or older. In the second stage, the trial intends to enrol 4,900 participants: 3,500 healthy adults aged 18 years or older, and 1,400 children aged 1-17 years. The study will initially be conducted at two sites in Guinea (Conakry/Landréah and Maferinyah) and one site in Liberia (Monrovia), with an additional site in Sierra Leone awaiting confirmation.
The main objectives of the PREVAC Ebola vaccine trial are as follows:
- To further explore the safety of three Ebola vaccination strategies and their ability to trigger a protective and durable immune response against Ebola virus
- To assess these vaccination strategies in the general population and in important groups, such as children, for which there is only limited information available
- To obtain information on the duration of the immune response induced by the vaccines