Clinical Trial: A Study to Assess New Ebola Vaccines, cAd3-EBO Z and MVA-BN® Filo

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase Ia, Dose-Escalating, Safety and Immunogenicity Trial of the Monovalent Zaire Ebola Viral Vector Candidate Vaccine cAd3-EBO Z and the Heterologous Prime-boost Candi

Brief Summary: The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. The investigators will do this by giving volunteers a either one or two vaccinations, doing blood and saliva tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use either of these vaccines in humans. We plan to recruit a total of 92 volunteers to be vaccinated.

Detailed Summary:

Long- term immunology follow-up: In order to assess the durability of vaccine induced immunogenicity, all vaccinated subjects will be invited back to attend a maximum of 3 further optional follow up visits at least 12 months after their final vaccination. The 3 visits will have a minimum interval of 3 months between them, and the final visit must take place no longer than 12 months after the first optional visit.

Volunteers who attend these visits will be asked about occurrence of any SAEs during the intervening period. SAE data for this period will not be collected in those volunteers who decline to attend these additional visits.


Sponsor: University of Oxford

Current Primary Outcome: Safety and tolerability of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ]

The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.


Original Primary Outcome: Same as current

Current Secondary Outcome: Cellular and humoral immunogenicity of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ]

The primary immunogenicity outcome measures are ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining (ICS) assay for T cell responses.


Original Secondary Outcome: Same as current

Information By: University of Oxford

Dates:
Date Received: September 10, 2014
Date Started: September 2014
Date Completion: March 2017
Last Updated: July 12, 2016
Last Verified: July 2016