Ebola Vaccination Program: Phase II Studies Started
Clinical phase II studies have now started for the Ebola vaccine that is currently being developed by Janssen. This was announced in mid-July by Janssen’s parent company, Johnson & Johnson. Following the analysis of provisional data on safety and immunogenicity from phase I studies, the company is now in a position to expand the tests and include more subjects. The studies are initially being conducted on a total of 612 healthy adults in the UK and France. A follow-up study on 1,200 healthy adults is to start in the third quarter of 2015 in West and East African countries that are not affected by Ebola.
A prime-boost vaccination regimen is being tested: volunteers are initially given a primer vaccine (Ad26 produced by Janssen) and then a booster (MVA produced by the Danish biotechnology company Bavarian Nordic) at intervals of 28, 56 or 84 days to reinforce the immune response. The primary aim is to evaluate the safety and tolerability of these three different vaccination regimens. Furthermore, the immune response is to be analyzed in the long run. The study sponsor is Crucell Holland B.V., which is owned by Janssen.
The combined phase II Ebola studies will be made possible through collaboration between several partners who are brought together under the umbrella of the Innovative Medicines Initiative Ebola+ program. The EBOVAC2 program is managed by Inserm and will advance the clinical development of phase II of the prime-boost vaccination regimen. Participants in the EBOVAC2 project are Janssen, Inserm, Inserm Transfert, the London School of Hygiene & Tropical Medicine, Le Centre Muraz and the University of Oxford.
The phase I studies are being continued in parallel in Kenya, Uganda and Tanzania and have also been authorized in Ghana by the responsible Food and Drugs Authority (FDA).
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