drugset / Trial / NCT02083887

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

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2014-02
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator ChAd63 ME-TRAP Vaccine 5e+10 unknown Intramuscular
Comparator MVA ME-TRAP Vaccine 1e+08 unknown Intramuscular

Indications