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Navy making strides in finding vaccine for malaria

Navy making strides in finding vaccine for malaria

Lt. Kimberly Edgel, left, and Christian Baldeviano examine a positive malaria blood smear at U.S. Naval Medical Research Unit 6. NAMRU-6 is studying the interplay between malaria and the human immune system to identify new malaria vaccine targets. (Courtesy photo)

By Rindi White

Two children die every minute due to malaria around the world, says Capt. Judith Epstein, the clinical director of the United States Naval Medical Research Institute’s malaria program.

Roughly 200 million people are treated each year for malaria around the world, Epstein said in a March story posted on the Naval Medical Research and Development’s website.

“Malaria has had a greater impact on manpower than enemy fire in all of the conflicts that occurred in tropical regions in the 20th century,” Epstein said in a 2017 Department of Defense news video about the fight against malaria. (See the video here.

The U.S. Navy has been working for nearly 80 years to find an effective way to stop the disease. The Naval Medical Research Institute has conducted many investigations into new anti-malarial drugs, methods of curbing the ability of mosquitoes to spread the disease and other foundational malaria research, work that has helped researchers around the world better understand the disease.

The Navy and the U.S. Army are leading clinical trials of biotechnology company Sanaria’s Plasmodium falciparum sporozoite, or PfSPZ, vaccine, and, with positive results so far, it may spell a historic breakthrough on the horizon.

According to the results of a first-phase clinical trial, PfSPZ appears to be safe, easily administered and it provided protection for at least 14 months in subjects exposed to Plasmodium falciparum parasites. In the trial, volunteers received intravenous inoculations of the vaccine, which is made from live, weakened, purified malaria parasites that do not cause illness. Twenty-one weeks after the vaccination, nine of the volunteers were protected against exposure to the bite of a malaria parasite-infected mosquito. Five of those nine volunteers were exposed to parasite-infected mosquitoes again at 59 weeks after inoculation and all were protected against infection.

According to a press release from Sanaria, future clinical trials of the vaccine are expected in the United States, Africa and Europe. If results are similar to the first-stage clinical trials, the company hopes it will lead to the licensure of an affordable vaccine for use in mass vaccine administration campaigns in countries most affected by the disease, and to prevent malaria in travelers. 

“The results completely change the landscape in terms of having a highly protective malaria vaccine with sustained protection within reach. The data from this trial support the design and conduct of ongoing studies by the International PfSPZ Consortium intended to finalize an optimized vaccine regimen for phase three clinical trials and licensure of a PfSPZ Vaccine regimen that protects greater than 80 percent of recipients for at least 6 months,” said Stephen L. Hoffman, CEO of Sanaria. “We intend to use PfSPZ vaccine for preventing malaria in individuals, halting transmission of the malaria parasite and eliminating the parasite through mass vaccine administration campaigns. It’s reasonable to suggest that within three to four years a safe, reliable vaccine could be a commercial reality and provide medical benefit to a huge population.”

Hoffman is a retired U.S. Navy captain. From 1987 to 2000, Hoffman directed the Naval Medical Research Institute’s malaria program. From 1995 to 2005, he was the most cited author for scientific papers on malaria, according to information from the U.S. Medical Research and Development website.

In January, Sanaria announced that a second clinical trial, this time conducted by clinical investigators with the Naval Medical Research Center and Walter Reed Army Institute of Research was also successful.

Sixty-nine volunteers between 19 and 45 years old participated in the trial. Three weeks after the last vaccination, 25 of the 28 volunteers who received either three or five doses of PfSPZ were protected against malaria parasites similar to those in the vaccine. Eighty percent of those tested were protected against parasites different than those specifically in the vaccine. And 24 weeks after the last dose of vaccine, 63 percent of the volunteers exposed were again protected against parasites similar to those in the vaccine.

“Our military continues to be at risk from malaria as it deploys worldwide. We are excited about the results of this clinical trial, and are now investing in the ongoing clinical trial to finalize the vaccination regimen for PfSPZ vaccine. Because this disease has such strong potential to interrupt our mission of national defense and creates an ongoing, adverse impact on this nation’s military readiness, malaria vaccine development continues to be among our highest priorities. We look forward to working with Sanaria and other colleagues to develop and license a safe, effective malaria vaccine for U.S. service members and the world community,” said Kenneth A. Bertram, M.D., Principal Assistant for Acquisition for the US Army Medical Research and Materiel Command in Ft. Detrick, Maryland, in a press release from Sanaria. 

According to the company, more than 800 healthy volunteers ranging in age from 5 months to 65 years of age have participated in Santaria’s PfSPZ vaccine trials so far. In January, the company began a phase two trial in Kenya to assess the safety, tolerability and protective efficacy of the vaccine on infants between 5 and 12 months of age, living in an area of high-malaria transmission. According to The Foundation for Vaccine Research, the hope is that the vaccine will show high-level sterilizing protection for at least a year. It would be the largest study to date of PfSPZ vaccine, and it’s being conducted in collaboration with the Kenya Medical Research Institute, the U.S. Centers for Disease Control and Prevention, and with financial support from the Vaccine Research Center, National Institute of Health and National Institute of Allergy and Infectious Diseases.

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