Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
| Status: | Archived |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
| End Date: | October 2010 |
Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn
The purpose of this study is to compare the safety and immunogenicity over an 8-month period
of three different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive two doses of
the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in
all Household Contacts residing with the vaccinated volunteers.
At least 96 healthy Vaccinees will be randomized into 3 ascending dosage cohorts each
consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly
assigned to receive 2 doses of either Ad4-H5-Vtn or placebo separated by approximately 56
days. Volunteers will be followed for 180 days post-second vaccination.
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