Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

September 30, 2004

Study Completion Date

July 31, 2005

Conditions
Malaria
Interventions
BIOLOGICAL

FMP1/AS02A

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.

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.

Trial Locations (1)

Unknown

Bandiagara Malaria Project, Bandiagara

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

United States Agency for International Development (USAID)

FED

lead

U.S. Army Medical Research and Development Command

FED