In a step towards development of a malaria vaccine, the Walter Reed Army Institute for Research (WRAIR), the United States Army Medical Materiel Development Activity (USAMMDA), GlaxoSmithKline Biologicals,
University of Maryland School of Medicine and University of Bamako located in Mali, West Africa, have published the results of a Phase 2b human trial using the Apical Membrane Antigen-1 (FMP2.1) protein vaccine in
the New England Journal of Medicine.
The FMP2.1 vaccine, co-developed by WRAIR scientists, Dr. Sheetij Dutta and Dr. David Lanar, targets the most deadly malaria parasite, P. falciparum, which is a leading cause of infant mortality in sub-Saharan
Africa and tropical regions of the world. This vaccine has been extensively tested for safety in previous human trials in the United States and in Mali. The published study was designed to determine the efficacy of the
WRAIR FMP2.1 vaccine in combination with the GlaxoSmithKline Biologicals adjuvant AS02A, in a target population of 400 children living in an endemic area of Mali.
Although this FMP2.1/AS02A vaccine failed to prevent malaria in the vaccinated volunteers, it did successfully reduce clinical malaria caused by a parasite strain from which the vaccine was derived.
"There was a wide variety of malaria parasite strains in the test area and the observed strain-specific protection is very encouraging for researchers developing a second-generation vaccine that can neutralize
all P. falciparum strains," said Dr. Dutta at WRAIR.
The trial was conducted under the joint leadership of Dr. Mahamadou Thera of the University of Bamako, Dr. Chris Plowe from the University of Maryland’s Center for Vaccine Development and Dr. Gray Heppner formerly at WRAIR.
Oversight for clinical monitoring, protocol review and case report form review were provided by the Division of Regulated Affairs and Compliance at USAMMDA. USAMMDA also served as the Sponsor of the investigational new drug.
The National Institute for Allergy and Infectious Diseases supported the trial through a grant to the University of Maryland School of Medicine. Additional funding for the trial was provided by the U.S. Agency for International
Development’s Malaria Vaccine Program, which also supported the development of the vaccine at WRAIR.
COL. Chris Ockenhouse, the director of the Malaria Vaccine Development Program at WRAIR, said that, "This study is the pivotal foundation for an improved vaccine to prevent clinical malaria in children and WRAIR is excited to
continue to support the development of a second generation vaccine".