MedTrace Logo

A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants

NCT02083887 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2015-12-03

No results posted yet for this study

Summary

Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a safe and effective vaccination strategy against malaria. The vaccines have been found to be well tolerated when tested in Gambian adults, young children and infants, who are at risk of severe malaria. Both vaccines will be given to participating infants at the same time as some EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still helpful in making the body's defense system respond.

Conditions

Interventions

BIOLOGICAL

ChAd63 ME-TRAP / MVA ME-TRAP

Intramuscular administration of ChAd63 ME-TRAP 5 x 10\^10 vp and MVA ME-TRAP 1 x 10\^8 pfu

Sponsors & Collaborators

  • Malaria Vectored Vaccines Consortium

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Muhammed Afolabi · Medical Research Council Unit, The Gambia Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • The Gambia

Study Locations

More Related Trials

Entities

Diseases

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 NCT02083887 on ClinicalTrials.gov