The Trials – Phase 1

Phase 1 trials have been carried out in the UK, Kenya, Tanzania and Uganda. These Phase 1 safety trials gathered preliminary information on the safety and tolerability of the vaccine regimen. The immune response generated by the regimen will also be evaluated longer term. The final participant visits in the Phase 1 trials took place in September 2016.

The first published clinical data from the Phase 1 site in Oxford, UK, suggests that the regimen was well-tolerated by healthy volunteers and immunogenic. Among the findings, 100 percent of participants in the study achieved an initial antibody response to Ebola, and this response was sustained 8 months following immunization.

Phase 1 trial sites

The Phase 1 studies in Africa are coordinated by Dr Deborah Watson-Jones, Clinical Epidemiologist at the London School of Hygiene & Tropical Medicine. A list of Phase 1 trial sites and trial lead contacts is below.

Trial site Organisation Lead contact
Kenya KAVI-Institute of Clinical Research, University of Nairobi Professor Omu Anzala, Director
Tanzania Mwanza Intervention Trials Unit (MITU), Mwanza Dr George PrayGod, Deputy Director
Uganda Medical Research Council/ Uganda Virus Research Institute (MRC-UVRI), Entebbe Professor Pontiano Kaleebu, Director
United Kingdom Oxford Vaccine Group, University of Oxford Professor Andrew Pollard, Professor of Paediatric Infection and Immunity.  Dr Matthew Snape, Consultant in General Paediatrics and Vaccinology
MITU (Tanzania) trial team visit the KAVI (Kenya) trial site (Deborah Watson-Jones)

MITU (Tanzania) trial team visit the KAVI (Kenya) trial site (Credit: Dr Debby Watson-Jones)

These projects have received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOMAN (grant nr. 115850) and EBODAC (grant nr. 115847). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA).
www.imi.europa.eu
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