drugset / Trial / NCT01739036

A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches Using the ChAd63 and MVA Vectors Encoding the Antigens ME-TRAP, CS and AMA1

NCT01739036

Phase 1/2 Completed 48 enrolled University of Oxford
RandomizedParallel-groupSingle-blindBasic science

Summary

This is an open label, multi-centre phase I/IIa sporozoite-challenge trial to assess the safety, immunogenicity and efficacy of two combination ChAd63-MVA heterologous prime-boost vaccination regimens. All volunteers recruited will be healthy, malaria naïve adults aged between 18 and 45 years. To determine the efficacy of each of two combinations of heterologous prime-boost immunisation strategies: 1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS 2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1 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
2013-01
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator ChAd63 AMA1 Unknown 5e+10 unknown Intramuscular
Comparator ChAd63 CS Vaccine 5e+10 unknown Intramuscular
Comparator ChAd63 ME-TRAP Vaccine 5e+10 unknown Intramuscular
Comparator MVA AMA1 Vaccine 1.33e+08 unknown Intramuscular
Comparator MVA CS Vaccine 1.33e+08 unknown Intramuscular
Comparator MVA CS Vaccine 2e+08 unknown Intramuscular
Comparator MVA ME-TRAP Vaccine 1.33e+08 unknown Intramuscular
Comparator MVA ME-TRAP Vaccine 2e+08 unknown Intramuscular