WEDNESDAY, SEPTEMBER 28, 2016

Sanaria announces successful Phase I clinical trial of malaria vaccine

Sanaria announced on Thursday that the Phase I clinical trial of its PfSPZ vaccine, an investigational vaccine to protect against malaria, successfully protected subjects from developing malaria.

Plasmodium falciparum is the parasite responsible for causing malaria, a disease that claims more than 600,000 lives annually. The disease is transmitted by infected mosquitoes and poses the biggest threat to African countries. The study is a step towards being able to combat the disease, for which there are not many effective treatment options.

"While we're still in the early stages of testing, we believe this vaccine will be used to eliminate malaria," CEO of Sanaria Stephen L. Hoffman said. "It's reasonable to suggest that within three-to-five years, a safe, reliable vaccine could be a commercial reality and provide medical benefit to a huge population."

The study was conducted by researchers of Sanaria, a company dedicated solely to the purpose of developing vaccines to treat malaria. The results of the study were published online in the August 8 issue of Science magazine.

"Scientists have struggled to produce an effective malaria vaccine for more than three decades," Hoffman said. "These results show that we have a safe, successful, injectable vaccine that has the potential to save millions of lives."

The Phase I trial took human volunteers and administered them doses of the PfSPZ vaccine, which contains live, weakened malaria parasites that will not cause illness, after exposing them to malaria-infected mosquitoes. Forty volunteers participated; six received the highest dosage available. The six volunteers that received the highest dosage did not develop malaria.

"This whole-parasite vaccine, produced in a form that can be easily administered, is now shown to stimulate immunity with a clear dose response leading to full protection," Sanaria board member and Princeton professor Dr. Adel Mahoud said. "Not only was the vaccine fully protective, it was remarkably safe and well-tolerated."

The next phase of clinical trials will be conducted at Tanzania's Ifakara Health institute, to be followed by trails in Europe and the U.S. Sanaria representatives are confident the vaccine will be approved for use.

"This great advance in the development of a whole parasite vaccine immediately opens up important opportunities for immunization studies in malaria endemic countries," chief executive director of Tanzania's Ifakara Health Institute Salim Abdullah said. "My colleagues and I are very excited about working with Sanaria."