Trial status April 2020
The aim of the EBL2002 study in Africa is to test the vaccine for safety and immunogenicity in a total of 1,056 study participants including healthy adults and population groups including the elderly, HIV-infected adults, adolescents and children. In total, 1,885 participants have been screened and 1,075 have been randomized across cohort 1 (669 healthy adults), cohort 2A (142 HIV-infected individuals), cohort 2B (132 healthy adolescents aged 12 to 17 years) and cohort 3 (132 children aged 4 to 11 years) of which 1,017 have received the Dose 2 vaccination.
A booster dose (Ad26.ZEBOV) was given to 90 study participants to confirm the establishment of memory and development of an anamnestic response.
All study cohorts are now completed. Sample analyses are still ongoing on cohort 2B (132 healthy adolescents aged 12 to 17 years) and cohort 3 (132 children aged 4 to 11 years).
The EBL2001 trial in Europe (UK, France) has been completed. 423 study participants have been randomized (143 were randomized in reporting year 1 and 280 in reporting year 2), of which 290 have received the second dose vaccination. The site close-out visits have been performed. Volunteers are now being followed for five years in a long-term safety follow-up study, EBL4001.
Sample core analysis has been completed in the US for the main immune response. The focus is now on the additional immunogenicity testing conducted in France and in the UK.
From a scientific perspective
Thanks to the finalisation of Cohort 1, the first results in EBOVAC2 on the immune response to the vaccine were obtained by the Oxford Vaccine Group (UOXF) in a subcohort of 30 participants in the UK. During the last 12 months, UOXF has been characterising the B cell response to Ad26.ZEBOV/MVA.BN.Filo and has shown strong plasma cell responses and also identified their phenotypes. The group has also begun preliminary analysis of the antibody VH-gene response post Ad prime and MVA boost and initial isolation of monoclonal antibodies has been achieved by the Townsend group.