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NIAID HIV and Emerging Infectious Diseases Program

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Study name

Phase 1 Study of Safety and Immunogenicity of AD4-H5-VTN in AD4 Seronegative Volunteers (Short name – SAMOSA)

Study number:  11-I-0259

Goal of Study

The purpose of this study is to test an experimental H5N1 influenza (also known as bird flu or avian flu) vaccine to see if it is safe. The vaccine uses a live adenovirus as a carrier (or transporter). Adenoviruses are naturally occurring viruses that typically cause symptoms of a cold or conjunctivitis (a superficial eye infection). 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 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.

If we find a safe dose (amount) of adenovirus vaccine 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. We plan to enroll up to 68 subjects that will receive the study vaccine. We estimate that an additional 68 intimate contacts will be enrolled in this study.

Study Regimen:  We will recruit 68 subjects (and up to 68 of their intimate contacts who are age 18 to 65) who are healthy individuals. Volunteers must be in good general health, and be willing to receive a live vaccine. Volunteers must also be willing to spend 7 days hospitalized at the National Institutes of Health (NIH) and to return for at least 6 visits up to 12 months following vaccination. Intimate contacts must come to NIH for two visits. Volunteers and their intimate contacts will be compensated.

Eligibility Criteria:

  • You are 18–49 years old and are HIV negative
  • Your intimate contacts (if applicable) are between 18–65 years old and do not have a weakened immune system and are not pregnant
  • Your intimate contacts (if applicable) will not receive the vaccine but will agree to be seen at NIH two times
  • You are healthy
  • You are not pregnant or breast feeding
  • You are willing to have an HIV test
  • You are willing to receive a live vaccine
  • You have not had the bird flu or have received a vaccination for the bird flu

Last Updated April 08, 2013

Last Reviewed April 08, 2013