drugset / Trial / NCT00652275

Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine

NCT00652275

Phase 2 Unknown 378 enrolled African Malaria Network Trust
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults and twice in children proved to be safe in all three occasions for this phase IIb study in children to proceed. This study will include children who will be randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide or the Verorab control. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be followed-up for immediate reactions to vaccination, extended safety profile and immunological response associated with protection from malaria. These children will be followed up for over a longer term of two years. Blood will be taken to evaluate the biological safety parameters and also the immune responses.

Timeline

Start
2008-05
Primary completion
2010-11
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject MSP3 Long Synthetic Peptide Vaccine 30 ug
Comparator Rabies vaccine Vaccine 0.5 ml