Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali

PHASE2CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Plasmodium Falciparum Malaria
Interventions
BIOLOGICAL

FMP2.1/AS02A

3 doses administered a month apart: 50 µg recombinant subunit protein FMP2.1 (Plasmodium falciparum Apical Membrane Antigen-1 from strain 3D7 expressed in and purified from Escherichia coli), adjuvanted with 0.5 mL of AS02A (proprietary oil-in-water emulsion and phosphate buffered saline with the immunostimulants monophosphoral lipid A and QS21).

BIOLOGICAL

Rabies Vaccine

White, freeze-dried vaccine for reconstitution with the diluent prior to use; dosage 1.0 mL of rabies vaccine.

Trial Locations (1)

Unknown

University of Bamako, Malaria Research and Training Center, Bamako

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

University of Maryland

OTHER

lead

U.S. Army Medical Research and Development Command

FED