drugset / Trial / NCT00452088
A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso
Phase 1
Unknown
45 enrolled
African Malaria Network Trust
London School of Hygiene and Tropical Medicine · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This will be a study of the safety of MSP 3 LSP candidate malaria vaccine in children aged 1-2 years in Burkina Faso. Three imminizations at 28 day intervals will be administratered subcuteneously on the shoulder region. The study will compare MSP3 with Engerix B vaccine to evaluate whether it is just as safe to give to children in malaria endemic country. The study will also evaluate whether the vaccine induces the expected immune responses. Two dose levels of MSP 3 will be evaluated; 15µg and 30µg to determine the one with the best safety and immune response profile.
Timeline
- Start
- 2007-04
- Primary completion
- 2008-05
- Completion
- 2008-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hepatitis B vaccine | Vaccine | — | Subcutaneous |
| Subject | MSP3 Long Synthetic Peptide | Vaccine | 15 ug | Subcutaneous |
| Subject | MSP3 Long Synthetic Peptide | Vaccine | 30 ug | Subcutaneous |