Data supports the IMI/Johnson and Johnson vaccine regimen as a preventative against Ebola in risk areas
Data published in the journal PLOS Medicine demonstrates that the IMI-funded Johnson & Johnson Ebola vaccine regimen was well tolerated and induced a robust immune response in both healthy adults and adults living with HIV. The data is from a Phase 2 study conducted in Burkina Faso, Cote d’Ivoire, Kenya and Uganda that enrolled 668 healthy adults and 142 adults living with HIV. There were no safety signals of concern, with reports of mainly mild to moderate adverse events such as localised pain at the injection site, fatigue and headache. The study also confirms that HIV infection (well-controlled via treatment with a highly-active antiretroviral therapy) did not have any apparent influence on the immune responses elicited by the vaccine regimen.
These findings, alongside data recently published in The Lancet Infectious Diseases, support the potential prophylactic use of the vaccine regimen to protect people at risk of acquiring Ebola. The regimen has already been granted marketing authorisation by the European Commission and prequalification from the World Health Organization (WHO).
“These data add to the growing body of evidence supporting the prophylactic use of the Johnson & Johnson Ebola vaccine regimen to protect people at risk of Ebola. This is critical to our vision of protecting some of the world’s most vulnerable and underserved people – including people living with HIV – by preventing Ebola outbreaks before they start,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.
Ebola has recently re-emerged in the Democratic Republic of the Congo, the latest in a series of outbreaks in Africa in just the past year. More than 30 outbreaks have been declared since the Ebola virus was discovered in 1976. IMI provided funding through the Ebola+ Programme to support a number of clinical trials and other vaccine development activities.
Statement from Johnson and Johnson