The Tübingen University Hospital in conjunction with its partner site Centre de Recherche Medicales Lambaréné (CERMEL) has analysed data from the first 39 participants in its Phase I Ebola vaccine trial, being conducted as part of a World Health Organisation (WHO) initiated consortium.
The study is investigating the vaccine candidate rVSV-ZEBOV-GP developed by the Canadian Public Health Agency and produced by the US firm NewLink Genetics. More recently, it has been bought by Merck, who are supporting further Phase I as well as Phase II and III trials.
In the initial phase, two doses of the vaccine were tested in 39 participants in Lambarene, Gabon. Safety, tolerability and immunogenicity of the vaccine were assessed with very promising results.
In addition, a variety of doses of the vaccine were tested at collaborating sites internationally and the data are summarised in a paper published in the New England Journal of Medicine on the 1st April.
rVSV-ZEBOV-GP is a unique vaccine which uses a replicating virus in which the coat protein, recognised by the immune system, has been replaced with a coat protein from the Ebola virus (EBOV). The study in Lambaréné has shown that a single injection of this vaccine is well tolerated and generates a good immune response to EBOV.
The study in Lambaréné, headed by Principle Investigator Dr. Maxime Agnandji and Tübingen’s Professor Peter Kremsner is currently vaccinating further adults in an attemptto establish an optimal dose, and will begin vaccinating adolescents and children later this month.
The data from this site are vital for informing further clinical trials of the vaccine, licensure proceedings and how it will eventually be deployed in West Africa.
Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe — Preliminary Report
N Engl J Med. DOI: 10.1056/NEJMoa1502924
S.T. Agnandji, A. Huttner, M.E. Zinser, P. Njuguna, C. Dahlke, J.F. Fernandes, S. Yerly, J., J-A. Dayer, V. Kraehling, R. Kasonta, A.A. Adegnika, M. Altfeld, F. Auderset, E.B. Bache, N. Biedenkopf, S. Borregaard, J.S. Brosnahan, R. Burrow, C. Combescure, J. Desmeules, M. Eickmann, S.K. Fehling, A. Finckh, A.R. Goncalves, M.P. Grobusch, J. Hooper, A. Jambrecina, A.L. Kabwende, G. Kaya, D. Kimani, B. Lell, B. Lemaître, A.W. Lohse, M. Massinga-Loembe, A. Matthey, B. Mordmüller, A. Nolting, C. Ogwang, M. Ramharter, J. Schmidt-Chanasit, S. Schmiedel, P. Silvera, F.R. Stahl, H.M. Staines, T. Strecker, H.C. Stubbe, B. Tsofa, S. Zaki, P. Fast, V. Moorthy, L. Kaiser, S. Krishna, S. Becker, M.-P. Kieny, P. Bejon, P.G. Kremsner, M.M. Addo, and C. A. Siegrist
Medizinische Klinik, Institut für Tropenmedizin
Prof. Dr. Peter G. Kremsner
Wilhelmstr. 27, 72076 Tübingen
Tel. 0049 (0)7071 29-87179
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