GREAT LAKES, Ill. (NNS) -- Phases two and three of Food and Drug Administration (FDA) approved trials of a drug developed to stop the traditional "boot camp crud" began last month, and could eventually reduce illness in as many as one-fifth of Sailors entering the Navy.
The adenoviral illness is caused by viral pathogens, or germs, that can make Sailors sick, said Cmdr. Kevin Russell, a medical epidemiologist from the Naval Health Research Center in San Diego and the Navy's lead physician overseeing the Navy's portion of the Army-led joint Army/Navy trials.
To ensure safety and effectiveness, several studies, or "trials," must be conducted before the vaccine is licensed by the FDA. Phase one saw 58 volunteer Army medics as subjects and was completed in 2004. Russell said phases two and three should be complete in late 2007.
"Careful FDA-licensing trials take many years," Russell explained. "The adenovirus vaccine trials are on an accelerated schedule. Use of vaccines in all recruits may begin in 2009."
Russell said an estimated 10-20 percent of all recruits lose some time from training due to adenoviral illness, clearly impacting recruit training success and readiness.
"Two types of the pathogens, serotype-4 and serotype-7, have a long, long history of making military recruits sick with fever, sore throat, cough, and sometimes upset stomachs and other symptoms," Russell said. "Recruits with adenoviral illness usually feel sick for three to 10 days, and this can impact their training."
Though very rare, complications from the illness such as severe pneumonia have resulted in death.
The goal of the trials is to replace oral vaccines that were given to U.S. military recruits from 1971 to early 1999. Naval Health Research Center (NHRC) surveillance of the illness from 1996-2001 determined that the adenovirus illness was still a problem and thus a vaccine was still needed.
"Unfortunately, the only manufacturer of adenovirus vaccines stopped production in 1996, and the U.S. military had to work to find a new manufacturer when the last of the vaccine supply ran out in 1999," Russell said.
The U.S. Department of Defense has funded the company Barr/Duramed to be the sponsor of the adenovirus vaccine trials, and to eventually manufacture the vaccines.
Russell's Navy adenovirus vaccine trial staff is two active-duty physicians, 11 full-time contractors and 110 part-time contractors. His team is working closely with the U.S. Army Medical Research and Materiel Command in Fort Detrick, Md., and researchers from the Walter Reed Army Institute of Research. The Army trials are being conducted at the Army Basic Combat Training Center in Fort Jackson, S.C.
The NHRC has a long history of successful research on respiratory infections, especially adenoviral infections, and NHRC houses the Navy Respiratory Disease Laboratory, Russell said, making it the ideal partner with the Army research team.
"Approximately 4,000 recruits will participate in these studies," he said. "Rigorous review and safeguards are in place to ensure that recruits who participate do so voluntarily and safely. More than 100 research professionals are working on these complex studies at each site because reacquisition of safe and effective adenovirus vaccines is a very high priority for the U.S. military."
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