drugset / Trial / NCT01623557

A Challenge Study to Assess the Protective Efficacy of Two Malaria Vaccine Candidates

NCT01623557

Phase 1/2 Completed 30 enrolled University of Oxford
RandomizedParallel-groupOpen-labelBasic science

Summary

This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS \& MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP). The hope is that these vaccines will induce immune responses in vaccinees that are able to prevent malaria. This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP. The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.

Timeline

Start
2012-04
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator ChAd63 CS Vaccine 5e+10 unknown Intramuscular
Comparator ChAd63 ME-TRAP Vaccine 5e+10 unknown Intramuscular
Comparator MVA CS Vaccine 2e+08 unknown Intramuscular
Comparator MVA ME-TRAP Vaccine 2e+08 unknown Intramuscular