Ebola Virus Disease Clinical Trial
Official 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
This is a clinical trial in which healthy volunteers will be administered two experimental
Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with
both vaccines one after the other in a prime/boost regimen.
All ChAd3-EBO-Z doses are 1x10^11 vp and all Ad26.ZEBOV doses are 5x10^10 vp.
Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days
later.
Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days
later.
Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days
later.
Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days
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.
The ChAd3-EBO-Z and Ad26.ZEBOV 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 and London, England. The study will be
co-funded by GSK Biologicals and Crucell Holland BV.
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