Johnson & Johnson begins Ebola vaccine trial in Sierra Leone
pharmafile | October 14, 2015 | News story | Research and Development | Ebola vaccine, Johnson & Johnson
Johnson & Johnson has begun a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies, in the first study conducted of Janssen’s Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic.
Trial recruitment for the EBOVAC-Salone study is underway, with the first volunteers having received their initial vaccine dose; the study 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- a Janssen subsidiary- and MVA-BN technology from Bavarian Nordic.
Volunteers in the study will initially be given the AdVac dose to prime their immune system, followed two months later by the MVA-BN dose to boost their immune response, with the goal of potentially strengthening and extending the duration of the immunity.
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
There is as yet no licensed vaccine, treatment or cure for the Ebola virus. The Ebola outbreak in West Africa began in March 2014 and has put the health care systems of Sierra Leone, Liberia and Guinea under tremendous pressure.
As of October 2015, over 28,400 people have been infected with the virus across the three countries, and nearly 11,300 have died – including more than 500 health care workers. In Sierra Leone specifically, nearly 14,000 cases of Ebola have been reported and nearly 4,000 people have died.
Speaking on the need for a vaccine, Paul Stoffels, chief scientific officer and worldwide chairman, Pharmaceuticals, Johnson & Johnson, says: “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.
“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 investing $200 million in a bid to boost its work on an Ebola vaccine in October 2014, Johnson& Johnson has pursued and 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, director of the London School of Hygiene & Tropical Medicine, comments: “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.”
Joel Levy
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