Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1

Completed · Phase 1 · Has a placebo group

Conditions studied: Bird Flu, Influenza

In brief

The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three 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. Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).

Key facts

Study ID

NCT01006798

Run by

Emergent BioSolutions

People needed

166

Starts

2009-10-01

Expected to finish

2011-09-01

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults and their healthy adult household contacts.

You may not qualify if…

• Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18.
• Childcare workers who have direct contact with children 5 years old and younger.
• Resides with Household Contacts who are under the age of 18 or over the age of 65.
• Received or plans to receive licensed inactivated 2009 H1N1 influenza vaccine from 14 days prior to 14 days after any study vaccination.
• Received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• The Center for Pharmaceutical Research — Kansas City, Missouri, United States
• University of Rochester — Rochester, New York, United States
• Coastal Carolina Research Center, Inc. — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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