A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z
Research type
Research Study
Full title
A Phase Ia clinical trial to assess the safety and immunogenicity of MVA-EBO Z alone and a heterologous prime-boost immunisation with ChAd3-EBO Z and MVA-EBO Z in healthy UK volunteers
IRAS ID
174444
Contact name
Adrian Hill
Contact email
Sponsor organisation
Research & Development Department - Oxford University Hospitals NHS Foundation Trust
Eudract number
2015-000593-35
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
This is a clinical trial in which healthy volunteers will be administered experimental Ebola vaccines. We will vaccinate four groups of volunteers.
Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu.
Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA EBO Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a dose of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4).
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
The cAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.
Healthy volunteers will be recruited in Oxford, England. The study will be funded by the Wellcome Trust.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0108
Date of REC Opinion
23 Feb 2015
REC opinion
Favourable Opinion