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Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination

NCT02485912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-06

Study results available
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Summary

This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen.

All ChAd3-EBO Z doses are 2.5 x 10\^10 - 3.7 x 10\^10 vp and all MVA-EBO Z doses are 1.0 x 10\^8 pfu.

All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7 days later.

The site of administration of the MVA-EBO Z vaccine differs between the two groups:

Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.

Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.

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 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 Dakar, Senegal. The study will be funded by GSK.

Conditions

  • Ebola Virus Disease

Interventions

BIOLOGICAL

ChAd3-EBO Z

This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein

BIOLOGICAL

MVA-EBO Z

This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein

Sponsors & Collaborators

  • Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Souleymane Mboup, MD; PhD · Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Senegal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485912 on ClinicalTrials.gov