First-of-its-kind vaccine expands malaria protection for pregnant women

The award was announced on April 21, 2009 at the World Vaccine Congress Washington conference. The Vaccine Industry Excellence awards recognize the accomplishments and contributions of companies and individuals working in the vaccine industry. Sanaria was named Best Early-Stage Vaccine Biotech from a group of nine companies shortlisted for the award. Other awardees included GlaxoSmithKline Biologicals for Best Vaccine R&D Pipeline and Merck for Best Prophylactic Vaccine.

  FDA approval for testing in humans watershed moment for unique malaria vaccine approach ROCKVILLE, Maryland – 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, such live vaccines are used for other diseases including smallpox, polio, and measles. When the attenuated parasite is given to individuals, they are expected to become immune to malaria and not get sick. Evidence that the Sanaria approach has the potential to confer high levels of protection against malaria comes from previous studies in which volunteers were exposed to the bites of mosquitoes harboring weakened parasites. While the technological challenges associated with translating this approach into an effective and safe vaccine based on live parasites had been widely viewed as insurmountable, Sanaria has developed novel technologies and constructed a unique manufacturing facility that allows scientists to manufacture the candidate vaccine. “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,” said Adel Mahmoud, former president of Merck Vaccines and membe

Every day 2000 children die from malaria in Africa alone. The infec6on is transmi9ed from human to human by bi6ng mosquitoes and remains one of the world’s most devasta6ng diseases. Despite many years of effort a vaccine is s6ll not available but is urgently needed, if we are to make an impact on this enormous problem.