A Phase I Study to Assess New Ebola Vaccines, cAd3-EBO Z & Ad26.ZEBOV
Research type
Research Study
Full title
A Phase I, safety and immunogenicity trial of the heterologous prime-boost regimen combining the monovalent Zaire Ebola viral vector candidates ChAd3-EBO-Z and Ad26.ZEBOV in healthy UK adults (EBL05)
IRAS ID
174183
Contact name
Adrian Hill
Contact email
Sponsor organisation
Research & Development Department - Oxford University Hospitals NHS Foundation Trust
Eudract number
2015-000594-12
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines.
The ChAd3-EBO Z and Ad26.ZEBOV are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply in humans. These viruses have extra DNA from one part of the Ebola virus in them so that after injection, the body makes Ebola proteins (but Ebola does not develop). The immune system recognises these ebola proteins and develops an immune response to Ebola without having been infected by it.
ChAd3.EBOZ will be given at a dose of 1 x 10^11 vp while Ad26.ZEBOV will be given at a dose of 5 x 10^10 vp. We will vaccinate four groups of volunteers.
Groups one and three will receive the ChAd3.EBOZ vaccine first followed by the Ad26.ZEBOV either 4 weeks (group 1) or 8 weeks (Group 3) later. Groups two and four will receive the Ad26.ZEBOV vaccine first followed by the ChAd3.EBOZ either 4 weeks (group 2) or 8 weeks (Group 4) later.
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
Healthy volunteers will be recruited in Oxford and London, England. The study will be funded by the GlaxoSmithKline Ltd. and Crucell Holland BV.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0267
Date of REC Opinion
18 May 2015
REC opinion
Further Information Favourable Opinion