H5N1 DNA Vaccine Trials Begin

The first NIH volunteer received a DNA-based H5N1 vaccine at the NIH Clinical Center in Bethesda. The candidate vaccine was the NIH vaccine off the assembly line at a new plant.

2006-01-07 The U.S. NIH Vaccine Research Center (NIH VRC) reported that it had begun human trials of its DNA-based H5N1 vaccine. This vaccine, developed by the National Institute of Allergy and Infectious Diseases VRC is based on a portion of the H5N1 DNA, rather than weakened or killed H5N1 virus. The vaccine operates by directive human cells to make proteins; these proteins then act as a vaccine against H5N1. The trial will include 45 volunteers aged 18 to 60. The non-placebo volunteers will reecive three injections of the research vaccine over two months. Their health will be tracked for one year.

VRC Director Gary Nabel's team at the VRC had previously demonstrated the effectiveness of this approach in animal models using both H5N1 and H1N1. The H5N1 influenza vaccine approach is similar to that used in other experimental vaccines the VRC has investigated -- including vaccines aimed at HIV, Ebola, SARS and West Nile.Dr. Nabel reported that the vaccine "is aimed at newer strains of the H5N1 virus that currently pose a threat in Indonesia and represents an example of our ability to respond to shifting viruses with modern technology."

The candidate vaccine was synthesized using a modified version of the hemagglutinin (H) gene from the H5N1 influenza virus, was manufactured at the VRC Vaccine Pilot Plant. This is the first VRC candidate vaccine to make it through the manufacturing process at the new Plant. Significantly, the trial vaccine went from research into clinical trials in under 6 months.

Want to participate? Go to http://www.clinicaltrials.gov or call the VRC at 866-833-LIFE (5433).

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