A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z

Ebola Virus Disease Clinical Trial

Official title: A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of MVA-EBO Z Alone and a Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy UK Volunteers

Status Active, not recruiting

Clinical Trial Summary

This is a clinical trial in which healthy volunteers will be administered experimental Ebola vaccines. The investigators will vaccinate four groups of volunteers.

Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu.

Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA EBO Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a dose of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4).

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 cAd3-EBO Z and MVA-EBO Z 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 funded by the Wellcome Trust.

Clinical Trial Description

It is important to answer this question to understand how best to deploy the vaccine in an outbreak setting, and to give an indication as to whether booster vaccinations may need to be considered to maintain immunity.

In light of this, the extension study has invited volunteers to attend some further optional follow up visits. It would involve obtaining some further blood tests to look for the same markers of vaccine induced immune response that were looked for in the first part of the trial. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

• NCT number: NCT02451891
• Study type: Interventional
• Source: University of Oxford
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 2015
• Completion date: August 2017