At a glance
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Influenza A 2009 H1N1 Human Challenge Study in Healthy Adult Volunteers
In Brief
A Phase 2 clinical trial evaluating Ca/04/2009/H1N1 Vero Grown Challenge Virus for Influenza. Completed, enrolled 49 participants across 1 site.
Detailed Summary
Background: \- A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy volunteers to see how the body responds to the virus. Objectives: * To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate flu infection in a healthy adult. * To study how the body s immune system responds to the virus. Eligibility: * Healthy volunteers at least 18 years of age. * Participants must be willing to remain in isolation for a minimum of 9 days. Design: * Participants will be admitted to a hospital inpatient isolation unit. They will be screened with a physical exam and medical history. They will also have heart and lung function tests. Blood, urine, and nasal swab/wash samples will be collected. * Participants will receive a single nasal spray of the flu virus. They will stay on the inpatient unit for at least 9 days. * Participants will be monitored for the length of their stay. They will have frequent blood tests and other procedures as needed. * Participants will be allowed to go home once they have had two negative tests for the virus. The tests will be given on two consecutive days....
Study Details
Timeline
Interventions
The human challenge virus will be administered intranasally to each participant using a nasal sprayer. A total volume of up to 1 mL of virus will be administered.