drugset / Trial / NCT01816113
Phase Ia Study of ChAd63/MVA PvDBP
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |