drugset / Trial / NCT00452088

A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso

NCT00452088

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

EvaluationDrugModalityDoseRoute
Comparator Hepatitis B vaccine Vaccine Subcutaneous
Subject MSP3 Long Synthetic Peptide Vaccine 15 ug Subcutaneous
Subject MSP3 Long Synthetic Peptide Vaccine 30 ug Subcutaneous

Indications