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Phase I Study of Safety and Immunogenicity of Intranasal AD4-H5-VTN in AD4 Seronegative Volunteers
The purpose of this study is to test an experimental vaccine to see if it is safe. The vaccine uses a live adenovirus as a carrier (or transporter). We hope that the adenovirus carrier will help the vaccine stimulate an immune response. An immune response is the body’s release of cells and substances that protect the body from infection and foreign matter. Another important goal is to see whether different routes (ways) of giving the vaccine cause different immune responses. We also want to see if the adenovirus in the vaccine is contagious or spreads to others. Adenoviruses are naturally occurring viruses that typically cause symptoms of a cold or conjunctivitis (a superficial eye infection). If we find a safe dose (amount) of adenovirus virus to stimulate the immune system, we hope to use this as a carrier for future vaccines to help prevent diseases such as malaria or HIV. Volunteers will be compensated.
We plan to enroll up to 68 subjects and their intimate contacts in this study. An intimate contact is someone you will kiss on the mouth, have intercourse with, or have oral sex with during the study. Each participant will be studied for a minimum of 6 months and possibly up to 12 months. While on the study, you will be monitored for vaccine-related side effects and treated at the National Institutes of Health (NIH) hospital in case any occur. The study will consist of at least nine separate visits for the person receiving the vaccine, and two visits for intimate contacts.
Because these are live viruses, you will likely produce live virus (virus shedding) in the nose, mouth, and stool for up to four weeks. You will be required to remain in the NIH Hospital in respiratory isolation for seven days or until you have two negative nasal washes taken one day apart (starting at Day 4), whichever comes first. This means you are no longer shedding the virus from your nose. Respiratory isolation involves wearing a surgical mask anytime you leave the hospital room. You can go outside but cannot enter common areas like the cafeteria or library. You will be given a Patient Information Sheet on respiratory isolation precautions.
Last Updated April 05, 2013
Last Reviewed April 05, 2013