CLINICAL TRIALS

BACKGROUND

U.S. service members, who often live and work in close quarters, have unique exposures and susceptibility to infectious disease that can decrease individual and unit readiness. The development of vaccines and therapeutics to protect against diseases that pose a threat to the health service members would enhance operational readiness.

VALUE

By leveraging our surveillance network, the Infectious Diseases team can enhance force health protection by contributing to the development of vaccines and preventive measures through research and support for clinical trials.

GOALS

Conduct clinical trials of in support of new vaccines and therapeutics
Provide vaccine effectiveness data to the CDC on the annual influenza vaccines
Evaluate vaccine efficacy (VE) against moderate or severe acute gastroenteritis due to genotype-specific (GI.1 and GII.4) norovirus strains
Evaluate VE against moderate or severe AGE due to any norovirus strains
Inform policies regarding disease prevention and diagnosis through the U.S. Food and Drug Administration’s clinical trials

CAPABILITIES

CAP accredited laboratory with a enterics and bacteriology sections specializing in the culture of respiratory pathogens
High-throughput PCR testing for a wide variety of pathogens

RESEARCH

Phase IIb, double-blind, randomized trial to evaluate the efficacy and immunogenicity of norovirus vaccine
Investigation of treatment with oseltamivir to decrease the amount of influenza virus detected in subjects over time

Bureau of Medicine and Surgery
7700 Arlington Blvd. Ste. 5113 Falls Church, VA 22042-5113
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General Navy Medical Inquiries (to Bureau of Medicine and Surgery): usn.ncr.bumedfchva.mbx.bumed-general-inquiries@health.mil