The first human trial of a DNA vaccine designed to prevent H5N1 avian influenza infection began on December 21, 2006, when the vaccine was administered to the first volunteer at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD. Scientists from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), one of the NIH Institutes, designed the vaccine. The vaccine does not contain any infectious material from the influenza virus.
Unlike conventional flu vaccines, which are developed by growing the influenza virus in hens' eggs and then administered as a weakened or killed form of the virus, DNA-based vaccines contain only portions of the influenza virus' genetic material. Once inside the body, the DNA instructs human cells to make proteins that act as a vaccine against the virus.
VRC Director Gary Nabel, M.D., Ph.D., together with a team of scientists from the VRC recognized the potential for employing new vaccine technology against influenza, a disease for which effective vaccines have long been made, but for which the reliability of supply and manufacturing capacity has been problematic. Dr. Nabel and his colleagues previously have shown the DNA vaccine approach to be effective against influenza viruses in animal models, including highly pathogenic viruses such as the H5N1 strain and the H1N1 virus that caused the deadly 1918 pandemic. The DNA vaccine used in this study is similar to other investigational vaccines evaluated by the VRC that hold promise for controlling other viruses, such as HIV, Ebola, SARS and West Nile.
The study will enroll 45 volunteers between the ages of 18 and 60. Fifteen will receive placebo injections and 30 will receive three injections of the investigational vaccine over 2 months and will be followed for 1 year. Volunteers will not be exposed to influenza virus.
The vaccine contains no infectious material, and the virus was not present during any stage of the manufacturing process, notes Julie E. Martin, D.O., principal investigator of the study. "It is impossible for the vaccine to cause infection," she adds, "because it employs new technology known to safely stimulate broad immune responses." NIAID researchers will measure immune responses to the vaccine, assess its safety, and compare its potency to more traditional vaccine approaches.
Individuals interested in enrolling in the trial may visit http://www.clinicaltrials.gov or call the VRC toll-free at 1-866-833-LIFE (5433).
NIAID News Office
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