Phase 1 trials were carried out in the UK, Kenya, Tanzania and Uganda in 2015/ 2016. These Phase 1 safety trials gathered preliminary information on the safety and tolerability of the two-dose vaccine regimen. The immune response generated by the regimen will also be evaluated longer term.
The first published clinical data from the Phase 1 site in Oxford, UK, indicates 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. The final data from Oxford, UK, published in March 2017, show that the vaccine regimen induced a durable immune response in 100 percent of healthy volunteers one year following vaccination.
The final data from Nairobi, Kenya, Mwanza, Tanzania and Entebbe, Uganda was published in February 2019. These data show that the vaccine regimen is also well-tolerated and highly immunogenic against Ebola in healthy adults in East Africa.
Phase 1 trial sites
The Phase 1 studies in Africa were coordinated by Professor 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 |