Johnson & Johnson (J&J) has initiated a clinical trial to evaluate the safety and immunogenicity of Janssen’s Ebola prime-boost vaccine regimen in Sierra Leone.
The Ebola vaccine regimen is currently under development at J&J’s Janssen Pharmaceutical Companies.
The EBOVAC-Salone trial is the first study conducted of Janssen’s Ebola vaccine regimen in a West African country affected by the recent Ebola epidemic.
The company has already started patient enrolment in the trial, and the first volunteers have received their initial vaccine dose.
Being conducted in Sierra Leone’s Kambia district, the EBOVAC-Salone trial tests a regimen consisting of two vaccine components based on AdVac technology from Crucell Holland, one of the Janssen Pharmaceutical Companies, and MVA-BN technology from Bavarian Nordic.
The trial will assess 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.
J&J chief scientific officer and Pharmaceuticals worldwide chairman Paul Stoffels said: "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."
In the first stage of the trial, the volunteers, approximately 40 adults aged 18 years or older, are being given the AdVac dose to prime their immune system.
The second stage will see around 400 individuals, including adolescents and children, vaccinated to further evaluate the safety and immunogenicity of the vaccine regimen across different age groups.
Additional stages are being finalised in consultation with the Sierra Leonean authorities and international health agencies.
London School of Hygiene and Tropical Medicine director, professor Peter Piot said: "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 trial is being conducted on a parallel track with multiple ongoing Phase I and II studies across the US, Europe and Africa as part of the accelerated development plan for the Ebola vaccine regimen.
Earlier this January, a consortium of global research institutions and non-government organisations led by Janssen Pharmaceutical secured more than €100m in grants from Europe’s Innovative Medicines Initiative to support the development, manufacturing and deployment of the vaccine regimen.
The investigational Ebola vaccine regimen is said to have been discovered in a collaborative research programme with the National Institutes of Health.
This September, Crucell Holland, a Janssen company, received $28.5m from the Biomedical Advanced Research and Development Authority to help accelerate the development of the prime-boost vaccine regimen.
The Ebola outbreak in West Africa, which began in March 2014, has seen more than 28,400 people infected with the Ebola virus across Sierra Leone, Liberia and Guinea, and nearly 11,300 have died, including more than 500 health care workers as of October 2015.
Image: In Ebola-affected Sierra Leone, Pharmacist Paul Borboh stands next to the clinic’s new vaccine storage fridges that contain the first doses of Janssen’s prime-boost vaccine regimen. Photo: courtesy of PRNewswire / Johnson & Johnson.