drugset / Trial / NCT01142765

Study to Assess Efficacy of New Malaria Vaccine Candidates AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP

NCT01142765

Phase 1/2 Completed 52 enrolled University of Oxford
Non-randomizedParallel-groupOpen-labelPrevention

Summary

This study aims to test the safety and efficacy of six new malaria vaccines - AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP \& MVA ME-TRAP. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during both liver and blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response) and thus provide protection against malaria infection. The protective efficacy of vaccines will be evaluated by challenging a small number of volunteers who have received the vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge).

Timeline

Start
2010-06
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AdCh63 AMA1 Vaccine 5e+10 unknown Intramuscular
Subject AdCh63 ME-TRAP Vaccine 5e+10 unknown Intramuscular
Subject AdCh63 MSP1 Vaccine 5e+10 unknown Intramuscular
Subject MVA AMA1 Vaccine 2.5e+08 unknown Intramuscular
Subject MVA ME-TRAP Vaccine 2e+08 unknown Intramuscular
Subject MVA MSP1 Vaccine 2.5e+08 unknown Intramuscular

Indications