The trial of the two-dose Ebola vaccine regimen aims to help tackle the current outbreak and strengthen future Ebola epidemic preparedness.
An international consortium will soon start a large-scale clinical trial of an Ebola vaccine regimen in the Democratic Republic of the Congo (DRC), which is currently experiencing the second worst Ebola epidemic in history. IMI has contributed significantly to the development of the two-dose vaccine regimen, which is manufactured by the Janssen Pharmaceutical Companies of Johnson & Johnson.
The new trial has been designed to prevent the spread of the epidemic beyond the areas that are currently affected, and if possible to gather crucial information about the effectiveness of the vaccine to be better prepared to fight Ebola in the future. The vaccine regimen will be offered to adults and children aged a year or older in communities near the outbreak who are considered at risk. In total, Janssen will donate up to 500 000 doses of the vaccine regimen for the trial.
The current Ebola outbreak in the DRC began in summer 2018; so far, there have been over 3 000 cases and 2 000 deaths. The introduction of this second vaccine was recommended by the World Health Organization’s Strategic Advisory Group of Experts on Immunization in May 2019 to complement ongoing use of another investigational vaccine, rVSV-ZEBOV, made by Merck Pharmaceuticals. The Merck vaccine is being used in a ring vaccination strategy targeting contacts of those with Ebola virus disease and other health and frontline workers at high risk.
The Janssen vaccine regimen includes two doses (one of Ad26.ZEBOV and the second of MVA-BN-Filo), spaced two months apart. To date, over 6 500 people have taken part in clinical trials of the vaccine regimen. The available data indicate that the vaccine is well tolerated and induces a robust immune response to the Zaire strain of the Ebola virus – the cause of the DRC outbreak.
A number of organisations have contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme. Specifically, the projects EBOVAC1, EBOVAC2 and EBOVAC3 supported earlier clinical trials of the vaccine regimen, while EBOMAN supported its manufacture. Finally, the EBODAC project successfully facilitated the engagement of local communities, something it is also poised to do in this latest trial in the DRC.
Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, and a member of the IMI Governing Board, said: ‘No single entity can solve this outbreak which has continued for more than a year. The global health community has come together in support of this initiative using Janssen’s investigational Ebola vaccine regimen to help prevent its further spread. This collaboration is essential, and a great demonstration of how the public and private sectors can work together to help tackle a public health crisis.’
The consortium carrying out the trial is led by the DRC Ministry of Health and Institut National de Recherche Biomédicale (INRB) and includes the London School of Hygiene & Tropical Medicine (LSHTM); the Coalition for Epidemic Preparedness Innovations (CEPI); Médecins Sans Frontières (MSF) and Epicentre; with the Wellcome Trust contributing critical strategic guidance. Janssen Vaccines & Prevention B.V. is donating the experimental vaccine regimen for the study.
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