BETHESDA, Maryland, Feb. 16, 2017 /PRNewswire/ -- In a report published today in The Lancet Infectious Diseases, (Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed Malian adults: a randomised, double-blind trial) investigators reported that Sanaria® PfSPZ Vaccine protected against natural infections of Plasmodium falciparum, the leading cause of malaria deaths and protection was sustained for the 24 weeks of the study in an area of Mali with intense malaria transmission.
The study was led by Dr. Mahamadou Sissoko, Malaria Research and Training Center (MRTC), University of Science, Techniques and Technologies, Bamako, Mali and by Dr. Sara Healy, Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, U.S. National Institutes of Health.
Five doses of PfSPZ Vaccine were administered to 44 subjects and saltwater placebo given to 44 subjects. Volunteers were followed for six months to determine presence of malaria parasites in the blood. A staggering 93% of the placebo group had one or more malaria infections; only 66% of vaccinated subjects acquired an infection. This represents 48% protective efficacy by time-to-event analysis and 29% efficacy by proportional analysis. There were no differences in adverse events between the vaccinated and placebo groups.
Sanaria CEO, Stephen L. Hoffman, MD said, "These are encouraging results which show significant protection with a dosage regimen that is sub-optimal. Ongoing clinical trials in Tanzania, Equatorial Guinea, Burkina Faso, Germany, the U.S., and Mali are intended to establish a PfSPZ Vaccine dosage regimen that will provide the high-level protection we seek."
PfSPZ Vaccine is composed of live, radiation-attenuated purified, cryopreserved malaria parasites administered in a 0.5 mL injection by rapid direct venous inoculation.
African children are hardest hit by malaria. In 2015 malaria caused 214M clinical episodes and 438,000 deaths worldwide according to WHO. This devastating impact occurs despite investment of billions of dollars in malaria control efforts. Malaria is also a concern for tourists, diplomats, business travelers, aid workers, industrial workers, and military personnel worldwide.
Professor Ogobara Doumbo, MD, PhD, Director of the Mali MRTC, said, "We have been waiting decades for a highly effective malaria vaccine. We have assessed many experimental malaria vaccines in Mali. This is by far the best result we have ever obtained. We are proud to have hosted the first field efficacy trial of PfSPZ Vaccine in Africa, and are expectantly awaiting results of our second study."
"These results provide evidence that protection against infection, not just disease, can be sustained for at least half a year. This is a cornerstone for us to home in on a PfSPZ Vaccine regimen that will provide high level, lasting protection to people living in malaria affected areas," said Professor Marcel Tanner, President, Swiss Academy of Sciences and Director Emeritus, Swiss Tropical and Public Health Institute. "Such a vaccine is an essential tool to achieve elimination. We are excited about clinical trials of PfSPZ Vaccine that stretch across Africa from Tanzania in the East to Equatorial Guinea in the West."
About Sanaria Inc.: Sanaria's mission is to commercialize whole-parasite malaria vaccines that confer high-level, long-lasting protection against malaria, and use these vaccines to prevent malaria in individuals and eliminate malaria from entire regions. Sanaria (http://www.sanaria.com [http://www.sanaria.com/]) is based in Rockville, Maryland.
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