J&J launches clinical trial of preventive Ebola vaccine regimen

Johnson & Johnson yesterday said it had launched a safety and immunogenicity clinical trial of a preventive Ebola vaccine regimen in Sierra Leone.

Trial recruitment is underway with the first volunteers receiving their initial vaccine dose, the company said in a statement.

According to the Johnson & Johnson, this is the first study 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 BV, 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 optimising 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 Paul Stoffels, MD, chief scientific officer and worldwide chairman, Pharmaceuticals, Johnson & Johnson.

"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."

Since announcing its commitment to combat Ebola in October 2014, Johnson & Johnson has mobilised significant resources to advance the research and development of an Ebola vaccine regimen with the goal of addressing the urgent public health need of affected countries such as Sierra Leone.

With this goal in mind, in 2015 Janssen developed partnerships and consortia with other companies and research institutions, secured funding from European and US public authorities, and launched multiple Phase I and II studies in rapid succession across the US, Europe and Africa.

Additionally, Janssen in partnership with Bavarian Nordic, rapidly scaled up production of the vaccine regimen to more than 800,000 regimens, with the capacity to produce a total of 2 million regimens as needed.

Professor Peter Piot, MD, director of the London School of Hygiene & 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."