Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
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|ClinicalTrials.gov Identifier: NCT00223990|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 4, 2013
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum.
Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions.
This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination.
One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine.
|Condition or disease||Intervention/treatment||Phase|
|Malaria, Falciparum||Biological: FMP1/AS02A||Phase 2|
Full, Unabbreviated Title:
A Double-blind, Randomized, Controlled, Phase IIb Field Trial in 12 to 47 Month-old Children in Western Kenya to Evaluate the Efficacy, Safety and Immunogenicity of the FMP1/AS02A Malaria Vaccine (WRAIR's MSP-1 Antigen Adjuvanted in GlaxoSmithKline's AS02A) Versus Rabies Vaccine
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Dbl-blind,Randomized,Controlled,Phase IIb Field Trial in 12-47 Month-old Children in Western Kenya to Eval the Efficacy,Safety and Immunogenicity of the FMP1/AS02A Malaria Vaccine vs Rabies Vaccine|
|Study Start Date :||March 2005|
|Study Completion Date :||April 2006|
- To assess the efficacy of the FMP1/AS02A malaria vaccine on clinical episodes of P. falciparum malaria during the Efficacy Follow-up Period (EFP)
- - To assess the efficacy of the FMP1/AS02A malaria vaccine against clinical episodes of P. falciparum malaria of differing severity during the EFP
- Safety and Immunogenicity
- - To assess solicited adverse events occurring in the seven days following each dose of vaccine
- - To assess unsolicited adverse events occurring in the 30 days following each dose of vaccine
- - To assess serious adverse events occurring after the first dose of vaccine to the end of the EFP
- - To assess the immunogenicity of the FMP1/AS02A malaria vaccine from the first dose of vaccine to the end of the EFP
- - To assess the association between MSP-1 antibody titers and the subsequent risk of clinical malaria during the EFP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223990
|Walter Reed Project|
|Kombewa Clinic, City of Kisumu, Nyanza Province, Kenya|
|Principal Investigator:||Bernhards Ogutu, M.D.||Kenya Medical Research Institute|