drugset / Trial / NCT01816113

Phase Ia Study of ChAd63/MVA PvDBP

NCT01816113 ↗

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

Summary

This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 \& MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.

Timeline

Start
2013-04
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ChAd63 PvDBP Vaccine 5e+09 unknown Intramuscular
Subject ChAd63 PvDBP Vaccine 5e+10 unknown Intramuscular
Subject MVA PvDBP Vaccine 1e+08 unknown Intramuscular
Subject MVA PvDBP Vaccine 2e+08 unknown Intramuscular