J&J starts clinical trial of Ebola vaccine in Sierra Leone

Study being initiated on parallel track with multiple ongoing Phase I and II studies across the US Europe and Africa as part of accelerated development plan for vaccine regimen

ebola

This is said to be the first study of Janssen’s prime-boost vaccine regimen in an Ebola outbreak country

Johnson & Johnson (J&J) has announced the start of a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies. Trial recruitment is underway, and the first volunteers have received their initial vaccine dose. This is the first study conducted of Janssen's Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic.

The new study, EBOVAC-Salone, will take place in Sierra Leone's Kambia district, where some of the country's most recent Ebola cases have been reported. The regimen being tested uses a combination of two vaccine components based on AdVac technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and MVA-BN technology from Bavarian Nordic. Volunteers in the study will first be given the AdVac dose to prime their immune system, and then the MVA-BN dose two months later to boost their immune response, with the goal of potentially strengthening and optimizing the duration of the immunity.

"Never again can Ebola be allowed to cause the human suffering that the world has witnessed in West Africa and we remain committed as ever to helping the international community combat this disease," said Dr Paul Stoffels, chief scientific officer and worldwide chairman, Pharmaceuticals, J&J. He added, "One of the many lessons learned from the outbreak is we cannot let our guard down with Ebola, and we need to test every promising prevention tool. It is our hope that this study will help to confirm the value of this vaccine regimen in Ebola control efforts - not just for Sierra Leone, but for the world."

Professor Peter Piot, director of the London School of Hygiene and Tropical Medicine, which is one of the partners conducting the study, said, "We cannot afford to be complacent about Ebola. We urgently need a vaccine that offers long-term protection of the population, including health workers and other care givers, in order to prevent a resurgence of the virus. To achieve this goal, it is vital to test a range of vaccine candidates, particularly in the areas affected by the epidemic where we are still seeing new cases emerging, and there is evidence that the infection may have longer-term effects among survivors. Prime-boost vaccination is an effective strategy for long-term prevention of several infectious diseases, and we believe it may have a key role to play in the fight against Ebola."

The EBOVAC-Salone study is notable in that it will evaluate the vaccine regimen's safety and immune response within the general population of Sierra Leone, including vulnerable groups such as adolescents, children, and people with HIV. In addition to the London School of Hygiene & Tropical Medicine which is coordinating the EBOVAC-Salone trial, Janssen is partnering with Sierra Leone's Ministry of Health and Sanitation, the College of Medicine and Allied Health Sciences, and two consortia of which Janssen is a member that are funded by Europe's Innovative Medicines Initiative (IMI): EBOVAC1 (Ebola Vaccine Development), which is conducting the study, and EBODAC (Ebola Vaccine Deployment, Acceptance & Compliance), which is developing a communication strategy and tools to promote the acceptance and uptake of the Ebola vaccine regimen.

 

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