drugset / Trial / NCT01450280

Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS

NCT01450280

Phase 1 Completed 24 enrolled University of Oxford
Non-randomizedParallel-groupOpen-labelPrevention

Summary

This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.

Timeline

Start
2011-12
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ChAd63 CS Vaccine 5e+09 unknown Intramuscular
Subject ChAd63 CS Vaccine 5e+10 unknown Intramuscular
Subject MVA CS Vaccine 2e+08 unknown Intramuscular

Indications