drugset / Trial / NCT01364883

Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP

NCT01364883

Phase 1 Completed 39 enrolled University of Oxford
Non-randomizedParallel-groupOpen-labelPrevention

Summary

This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.

Timeline

Start
2011-07
Primary completion
2013-07
Completion
2013-07

Drugs

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

Indications