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Researchers at NMRC Prepare for Third Clinical Phase of Malaria Vaccine Development

NMRC Malaria Human Challenge Photo

After extensive research and development (R&D) efforts, the Naval Medical Research Center (NMRC) team at the NMRC Clinical Trials Center (CTC), located on the campus of Walter Reed National Military Medical Center in Bethesda, Maryland, will test the effectiveness of an investigational malaria vaccine, with the help of human subjects, on February 2-3, 2017. While there are personal protective measures that can be taken to combat the threat of malaria, there is currently no licensed malaria vaccine.  

“In 2015, nearly half of the countries in the world had ongoing malaria transmission. This is a significant disease threat to deployed troops, with the risk varying year-to-year depending on the location of combat, humanitarian, and peacekeeping missions. Most military personnel from developed countries are not immune to malaria, and suffer high rates of morbidity and mortality when infected,” said Eileen Villasante, Ph.D., head of the NMRC Malaria Department

The United States Military Malaria Vaccine Program (USMMVP) includes researchers from the NMRC Malaria Department, Walter Reed Army Institute of Research (WRAIR) Malaria Vaccine Branch, and Department of Defense (DOD) medical research laboratories in Asia, Africa, and South America. USMMVP’s mission is to develop Plasmodium (P.) falciparum and P. vivax malaria vaccines to prevent malaria morbidity and mortality in military personnel and vulnerable populations for the benefit of global public health.

“There are malaria vaccines being developed and tested all over the world, but creating a vaccine that is 90- to 100-percent effective, Federal Drug Administration (FDA) approved, long-lasting, safe and tolerable, that protects against all strains of malaria, is a major challenge,” said Capt. Judith Epstein, Clinical Director, NMRC Malaria Department. 

“There are three stages in the life cycle of vaccine development and research,” explained Epstein. The first stage is discovery research, where researchers identify antigen targets and vaccine platforms, optimize antigen potency, and characterize mechanisms of protective immunity. 

In the second stage, known as the concept development/pre-clinical stage, researchers evaluate candidate vaccines in laboratory models, as well as manufacture and test vaccine candidates for progression to clinical development. 

The third stage of the research strategy is to test candidate vaccines in Phases 1 and 2 clinical trials.  Controlled human malaria infection (CHMI) is an important part of these clinical research activities.

“The CHMI part of the research strategy is really essential to the work we are doing,” said Capt. Nimfa Teneza-Mora, director of the NMRC Clinical Trials Center. “There are a lot of ways we recruit people for human challenges. Sometimes we run radio advertisements or put advertisements in busses and Metro trains, but we often recruit military members and civilians who volunteer because someone in their life has been impacted by malaria and they want to help, or they work in the research field.” 

On the day of the CHMI, subjects go through a regular checkup, have blood drawn, and are walked through the process of the challenge. While a daunting thought to some, the actual process for becoming infected as part of the challenge is no worse than being outside on a hot and humid summer day with no mosquito repellant. 

“The subjects are brought into the Walter Reed Army Institute of Research mosquito insectary, where there is a container with five malaria-infected Anopheles stephensi female mosquitoes. The subject will put his or her forearm on top of the container for approximately five minutes, where the mosquitoes will bite and feast on his or her blood. After the biting session, the mosquitoes will be dissected. This is where the insectary technician will look for sporozoites in the mosquitoes’ salivary glands.  After being bitten by 5 infected mosquitoes, the subject remains under observation for 30 minutes,” said Teneza-Mora.

While the CTC is currently preparing to conduct the CHMI for one malaria vaccine candidate, there are other vaccines in the R&D phase as well. The first immunization for a different malaria vaccine candidate is set to take place in the second quarter of 2017. The CTC is now actively recruiting volunteers for that upcoming trial.  

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