San Diego, California - The Naval Health Research Center (NHRC) has launched a clinical trial at Recruit Training Command (RTC) to evaluate the effectiveness of the first norovirus vaccine in reducing outbreaks of acute gastroenteritis, June 14.
Currently, there is no vaccine to prevent norovirus, a highly contagious disease which causes vomiting and diarrhea and can infect anyone who comes into contact with the pathogen. The virus can be spread by infected people, contaminated food or water, or contact with contaminated surfaces -- making populations living in close proximity, like military recruits, more susceptible to outbreaks.
"Norovirus is the largest cause of acute gastroenteritis in the United States," said Cmdr. Dennis Faix, preventive medicine physician at NHRC. "Military recruits are particularly vulnerable to the disease with recruits living side-by-side in the barracks. RTC has experienced outbreaks in recent years, which can significantly impact training populations, disrupt training schedules, and has the potential to cause long-term health consequences."
Extensive safety testing for this vaccine has been performed in civilian populations, but because the recruit training population regularly experiences large outbreaks of norovirus, it is a perfect place to test the effectiveness of the vaccine for the military, said Faix.
According to Lt. Cmdr. Lori Perry, preventive medicine physician and study co-investigator at NHRC, recruits entering basic training at RTC will be contacted during in-processing and researchers will explain the study. Interested recruits will be asked to volunteer and they can choose to stop participating at any time.
Once informed consent has been obtained and study volunteers are vaccinated, they will have three brief follow-up visits during basic training to have blood collected and evaluated to determine how their immune system is responding to the norovirus vaccine, as well as other vaccines received during in-processing.
"The health and safety of our recruits is our top priority," said Rear Adm. Stephen C. Evans, commander, Naval Service Training Command. "This trial will provide our recruits with the resources to stay healthy while they conduct their basic military training, which will better prepare them for service in the 21st century Navy."
The vaccine trial will last up to one year, said Faix, with results contributing to the assessment of vaccine effectiveness to support approval by the U.S. Food and Drug Administration for widespread use among other U.S. military populations and civilians.
NHRC has led safety and efficacy studies for other vaccines, including one for adenovirus, a contagious respiratory illness, at U.S. military recruit training centers. In 2007, NHRC collaborated with the FDA for an adenovirus vaccine clinical trial that resulted in the vaccine being reinstated at recruit training centers in 2011. Adenovirus was the most prevalent and widely spread virus in military training environments, infecting up to 80 percent of recruits prior to the vaccine being reinstated, resulting in lost training time and increased medical care; after 2011, adenovirus cases decreased from 250 each week to two.
As the DoD's premier deployment health research center, NHRC's cutting-edge research and development is used to optimize the operational health and readiness of the nation's armed forces. In proximity to more than 95,000 active-duty service members, world-class universities, and industry partners, NHRC sets the standard in joint ventures, innovation, and translational research.