Sanaria to begin human trials of malaria vaccine

A Rockville company plans to begin the first human clinical trials of a malaria vaccine that uses a weakened version of the entire malaria parasite, instead of just pieces of it, to help shield victims from the disease.

Sanaria Inc. is working with the Path Malaria Vaccine Initiative, a Bill and Melinda Gates Foundation-funded program at a global health nonprofit based in Seattle, to test an experimental vaccine for malaria on 104 healthy volunteers. The groups have already begun recruiting those volunteers after winning Food and Drug Administration approval for the trial and expect to inject the first patient in mid-May.

This first phase of clinical trials will test the vaccine’s safety and effectiveness at two locations: the 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.

The malaria vaccine, Sanaria’s first product to go into humans and the only one in its pipeline, is expected to produce its first clinical data results in November after the trial ends in September.

The company’s vaccine candidate contains a weakened form of the full live malaria parasite found in radiation-zapped mosquitoes to help patients gain immunity to the disease — a treatment method used similarly for smallpox, polio and measles. Most malaria vaccines being tested only contain genetically engineered proteins within small portions of the parasite, but Sanaria said it has created technology that allows physicians to deliver the full parasite into a patient’s system.

“Development of Sanaria’s vaccine candidate is based in part on the findings from parallel studies conducted in the early 1970s by teams at the Center for Vaccine Development and the Naval Medical Research Center,” said Myron Levine, director of the University of Maryland School of Medicine’s Center for Vaccine Development. These are “findings that were never translated into a vaccine development effort because the task was considered to be impossible.”

Sanaria officials said the trial will cost several million dollars, but would not disclose the exact figure. The roughly 50-person company, funded largely by the Gates foundation, opened a 23,500-square-foot manufacturing and lab facility on Medical Center Drive in the fall of 2007 to accommodate these tests.