VRC 304: A Phase I Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine (VRC-AVIDNA036-00-VP), Encoding for the Influenza Virus H5 Hemagglutinin Protein in Healthy Adults

Detailed Summary

This study will determine if an experimental avian flu (bird flu) vaccine is safe, whether it has side effects and if it can stimulate an immune response in people. The vaccine being tested in this study is made from DNA (genetic material) that codes for an influenza protein called hemagglutinin 5 (H5), which is based on the protein from the bird flu virus. The study will determine if the body creates resistance or immunity to the H5 protein. The hope is that an immune response to this protein may protect against bird flu virus infection. Healthy people between 18 and 60 years old who have been vaccinated with the current season's influenza vaccine may be eligible for this study. Participants are randomly assigned to receive injections of one of the following: 1) study vaccine at 1 mg dose, 2) study vaccine at 4 mg dose, or 3) placebo (salt-water solution). They receive three injections about 4 weeks apart in the upper arm muscle. Participants record their temperature and symptoms at home for 5 days after each injection, either on a diary card or electronically using the Internet, and report any side effects to a study physician or nurse as soon as possible. They return to NIH for clinic visits every 2 weeks for the first 12 weeks, then at week 26 and at week 42 to check for health changes or problems. Blood is drawn at all visits and urine samples are collected through week 10. If a participant develops serious side effects, the study physician may decide that he or she should not receive any further injections. However, all participants are asked to continue the follow-up visits even if they do not get the full set of three injections. ...

Study Details

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