Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali
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|ClinicalTrials.gov Identifier: NCT00308061|
Recruitment Status : Completed
First Posted : March 28, 2006
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Biological: FMP1/AS02A Biological: Imovax Rabies Vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blind Randomized Controlled Phase I Trial to Evaluate the Safety and Immunogenicity of WRAIR's MSP1 Candidate Malaria Vaccine (FMP1) Adjuvant in GSK Bio's AS02A vs. Rabies Vaccine in Semi-immune Adults in Bandiagara, Mali.|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||September 2004|
|Actual Study Completion Date :||July 2005|
Experimental: FMP1/AS02A Vaccine
500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
Active Comparator: Imovax Rabies Vaccine
1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Biological: Imovax Rabies Vaccine
Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.
- Number of Participants With Solicited Adverse Events by Immunization and Type [ Time Frame: Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67 ]Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.
- Geometric Mean Titers for Anti-FMP1 Antibody [ Time Frame: Days 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364 ]Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.
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): NCT00308061
|Bandiagara Malaria Project|
|Principal Investigator:||Mahamadou A Thera, MD MPH||University of Bamako Faculty of Medicine, Mali|