While studies are in the early stages, executives with Rockville biotechnology company Sanaria are pleased enough with results of a phase I clinical trial of its malaria vaccine that they hope to have a product on the market in three to five years.
Malaria, typically spread by mosquitoes, killed some 660,000 people in 2010, mostly in Africa, according to the World Health Organization’s latest report on the deadly disease. Scientists have struggled to produce an effective malaria vaccine for more than three decades, said Stephen L. Hoffman, CEO of Sanaria.
Sanaria’s results show that “we have a safe, successful, injectable vaccine that has the potential to save millions of lives,” Hoffman said in a statement. He could not be reached for comment on Monday.
The clinical trial’s results are “incredible,” said Douglas Doerfler, board chairman of the Tech Council of Maryland. Hoffman is on the Rockville-based organization’s board.
“It’s very exciting,” said Doerfler, president and CEO of Gaithersburg biotech MaxCyte, which is developing cell therapies to potentially treat leukemia and other diseases. “There is not an effective vaccine at all for this very serious disease.”
Hoffman and his team have been pioneering an innovative approach against malaria, he said.
“The results of the phase I clinical trial show that the vaccine appears to be 100 percent effective,” Doerfler said. “It could move very quickly to the market, which would be extraordinary.”
While researchers with numerous other companies and organizations are attempting to develop a malaria vaccine, Sanaria’s process is unique because it is made of a suspension of the malaria-causing parasite rendered harmless by a quick zap of radiation, Hoffman said in a previous Gazette story.
Before founding Sanaria in 2003, Hoffman was director of the malaria vaccine program at the Naval Medical Research Center in Silver Spring. In 2007, Sanaria opened a manufacturing plant in Rockville after obtaining a $29.3 million grant from the Bill & Melinda Gates Foundation, along with other funds from federal agencies and private groups.
“Top scientists are backing him because of his leadership, passion and determination,” Doerfler said.
The clinical evaluation was conducted at the National Institutes of Health Clinical Center in Bethesda by researchers from NIH’s National Institute of Allergy and Infectious Diseases, Silver Spring-based Walter Reed Army Institute of Research and the Naval Medical Research Center.
The study employed healthy adult volunteers ages 18 to 45 years who had never had malaria. Participants received various doses of the vaccine, which was made from live, weakened parasites of the malaria-causing Plasmodium falciparum strain, with some not vaccinated at all. All participants were exposed to bites by five malaria-infected mosquitoes.
After monitoring the subjects, researchers reported no severe adverse effects or malaria infections due to the vaccinations. They found that participants receiving the higher doses generated more antibodies and T cells — an immune system cell — against malaria.
Only three of 15 subjects who got the higher doses of the vaccine became infected with malaria after the mosquito bites, compared to 16 of 17 participants in the lower dosage group. Eleven of the 12 participants who were not vaccinated became infected.
Participants who contracted malaria through the trial were treated with anti-malarial drugs and cured at the NIH Clinical Center, where they stayed until they were shown to be free of infection.
A report of the study was published recently in Science journal. NIAID Director Anthony S. Fauci said he was “encouraged by this important step forward.”
Follow-up studies are planned, including research to evaluate the vaccine’s different dose schedules, possible protection against other Plasmodium strains and the durability of protection.
The Democratic Republic of Congo and Nigeria account for more than 40 percent of the estimated total deaths worldwide because of malaria, according to the WHO. Worldwide funding for malaria control programs, which take measures like spraying for mosquitoes, rose from about $100 million in 2000 to $1.8 billion last year, according to the WHO. The increased level of funding helped prevent some 1.1 million more deaths between 2001 and 2010, the WHO report says.
There were almost 1,700 reported cases of malaria in the U.S. in 2010, a 14 percent increase from 2009, according to the U.S. Centers for Disease Control and Prevention. Most cases involved travelers and immigrants returning from countries where malaria is more prevalent.