Maryland-based company Sanaria, with support from the PATH Malaria Vaccine Initiative, has initiated a Phase I clinical trial of its malaria vaccine candidate.
Unlike other malaria vaccine candidates, Sanaria said that its approach deploys a weakened form of the whole malaria parasite harvested from irradiated mosquitoes instead of small portions of the parasite.
Having met the FDA’s 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 2009.
Adel Mahmoud, former president of Merck Vaccines and member of Sanaria’s board of directors, said: The Sanaria team has been able to systematically overcome obstacle after obstacle in a remarkably short time. I look forward to working with the rest of the team to bring this vaccine over the finish line and into widespread use to prevent the devastating illnesses and deaths caused by malaria.