Just three weeks after it struck up a $28.5 million government partnership to advance its Ebola vaccine, Johnson & Johnson ($JNJ) announced on Friday that it is starting a safety and immunogenicity trial in Sierra Leone for its Ebola candidate.
The trial will take place in Sierra Leone's Kambia district, where some of the country's most recent Ebola cases have been reported, the company said in a statement. The two-stage trial will be the first time J&J's jab will be tested in an Ebola outbreak country. Stage 1 will enroll 40 adults and stage 2 will enroll 400 participants across age groups.
J&J's Janssen is partnering with Bavarian Nordic on a two-dose, prime-boost regimen. Trial participants will receive Janssen's jab as the first dose and two months later, they will receive Bavarian Nordic's as a booster.
While the most recent Ebola epidemic has largely abated, J&J is going full steam ahead.
"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," said Dr. Paul Stoffels, J&J's chief medical officer and worldwide chairman for pharmaceuticals. "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."
The partners' regimen is already in Phase I and II trials in the U.S., Europe and Africa. They have scaled up production of the regimen to more than 800,000, and they have the capacity to produce a total of 2 million regimens as needed.
The duo is partnering with the London School of Hygiene and Tropical Medicine, Sierra Leone's Ministry of Health and Sanitation, the College of Medicine and Allied Health Sciences and two consortia: EBODAC (Ebola Vaccine Deployment, Acceptance & Compliance) and EBOVAC1, of which J&J is a member. EBOVAC1 (Ebola Vaccine Development) was founded in January of this year with grants from the Innovative Medicines Initiative totaling more than €100 million.
Companies focusing on Ebola vaccines have been winning government grants left and right recently. In addition to J&J's four-year, $28.5 million partnership with the U.S. Biomedical Advanced Research and Development Authority, NewLink ($NLNK) won a $26.1 million BARDA grant and a team led by Inovio ($INO) picked up $24 million from DOD's Defense Advanced Research Projects Agency.
- here's the release