drugset / Trial / NCT00197054

Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.

NCT00197054

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.

Timeline

Start
2005-07
Primary completion
2006-09
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject RTS, S/AS01B Unknown 0.5 ml Intramuscular
Subject RTS, S/AS02A Vaccine 0.5 ml Intramuscular
Comparator Rabies vaccine Vaccine 1 ml Intramuscular