NCT02240875

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

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 Candidate Vaccine Regimen cAd3-EBO Z and MVA-BN® Filo in Healthy UK Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Ebola
• Ebola Zaire

Interventions

Type	Name	Description
BIOLOGICAL	cAd3-EBO Z at 1 x 10^10 vp	Low dose cAd3-EBO Z
BIOLOGICAL	cAd3-EBO Z at 2.5 x 10^10 vp	Medium dose cAd3-EBO Z
BIOLOGICAL	cAd3-EBO Z at 5 x 10^10 vp	High dose cAd3-EBO Z
BIOLOGICAL	4.4x10^8 TCID50s MVA-BN® Filo	High dose MVA-BN® Filo
BIOLOGICAL	2.2x10^8 TCID50s MVA-BN® Filo	Low dose MVA-BN® Filo
BIOLOGICAL	4.4 x 10^7 TCID50s MVA-BN® Filo	Very low dose MVA-BN® Filo

Timeline

• Start date: 2014-09-17
• Primary completion: 2017-08-22
• Completion: 2017-08-22
• First posted: 2014-09-16
• Last updated: 2018-07-06

Locations

1 site across 1 country: United Kingdom