NCT02495246

A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	ChAd3-EBO-Z
BIOLOGICAL	Ad26.ZEBOV

Timeline

• Start date: 2015-09-21
• Primary completion: 2017-08-22
• Completion: 2017-08-22
• First posted: 2015-07-13
• Last updated: 2018-04-11

Locations

1 site across 1 country: United Kingdom