Evaluation of Anti-Hemagglutinin Antibodies as a Correlate of Protection in an H1N1 Influenza Healthy Human Challenge Model

Detailed Summary

Background: \- Researchers want to know if a certain type of antibody in the blood affects whether people get influenza (the flu). They will study 2 different groups with different levels of anti-HA antibodies and expose them to the flu virus. They will study how the flu develops in a healthy person. This may lead to future studies to develop new vaccines and treatments for the flu. Objective: \- To study how people can be protected from flu infection. Eligibility: \- Healthy volunteers 18 to 50 years of age. Design: * Participants will be screened through the use of a medical history, physical exam, and laboratory tests. * Groups of 7 participants will stay in an isolation unit in a hospital for at least 9 days with no visitors. * Participants will be screened again upon admission. They will also have: * ECG: soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals. * Echocardiogram: a small probe will be held to the chest to take pictures of the heart. * Lung tests: participants will blow into a machine. * They will also have nasal fluid collected. This will be done either with a swab or with a tube of water washing out the nose. This will be done once every day. * The flu virus will be sprayed into the participant s nose. This will be done only once. * Participants will complete a questionnaire on day 1 and twice a day after that for 14 days. * A medical team will watch participants 24 hours a day. They will go home after 2 days of negative flu tests. * Participants will have 4 follow-up visits over 8 weeks.

Study Details

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