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Phase 1 Trial of Whole-Parasite Malaria Vaccine to Begin
Date:4/22/2009

FDA approval for testing in humans watershed moment for unique malaria

vaccine approach

ROCKVILLE, Md., April 23 /PRNewswire/ -- In a move that highlights the strength of public-private collaboration in tackling international health challenges, the Maryland-based company Sanaria Inc., with support from the PATH Malaria Vaccine Initiative (MVI), has initiated a Phase 1 clinical trial -- the first tests in adult volunteers -- of its unique malaria vaccine candidate. Unlike other malaria vaccine candidates, Sanaria's approach deploys a weakened form of the whole malaria parasite harvested from irradiated mosquitoes instead of small portions of the parasite.

Having met the US Food and Drug Administration's (FDA) rigorous safety, sterility, purity, potency, and reproducibility requirements for testing in humans, Sanaria's vaccine candidate is to be assessed in healthy US volunteers at two sites in Maryland -- the US Naval Medical Research Center Clinical Trials Center in Bethesda and the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore. Recruitment has begun for the safety and efficacy study that will involve some 104 volunteers, with inoculation of the first groups expected to begin in mid-May.

"Initiation of this trial expands the spectrum of malaria vaccines in clinical development today," said Dr. Christian Loucq, Director of MVI. "This trial marks a major achievement in a collaborative development effort that aims to determine whether Sanaria's vaccine candidate is safe and effective."

While most malaria vaccines in clinical development consist of recombinant or genetically engineered proteins that represent small portions of the parasite, Sanaria's Plasmodium falciparum sporozoite vaccine candidate contains a weakened form of the entire malaria parasite. While unique to the malaria vaccine field
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SOURCE Sanaria Inc.
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