Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults

Completed · Phase 1

Conditions studied: Influenza, Virus Diseases

In brief

Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The need for a vaccine to prevent the spread of AI among livestock and to humans is sorely needed. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults.

Key facts

Study ID

NCT00347672

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

42

Starts

2006-06-01

Expected to finish

2007-07-01

Last updated by the study team

2008-01-21

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Good general health
• Available for the duration of the trial
• Willing to use acceptable forms of contraception

You may not qualify if…

• Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
• Medical, work-related, or family problems as a result of alcohol or illicit drug use in the 12 months prior to study entry
• History of severe allergic reaction or anaphylaxis
• Current asthma or reactive airway disease
• History of Guillain-Barre syndrome
• HIV-1 infected
• Hepatitis C virus infected
• Positive for hepatitis B surface antigen (HBsAg)
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical corticosteroids are not excluded.
• Live vaccine within 4 weeks of study entry
• Killed vaccine within 2 weeks of study entry
• Absence of spleen
• Blood products within 6 months of study entry
• Current smoker
• Have traveled to the Southern Hemisphere or Asia within 14 days prior to study entry
• Have traveled on a cruise ship within 14 days prior to study entry
• Work in the poultry industry
• Investigational agents within 60 days prior to study entry, or currently participating in another investigational vaccine or drug trial
• Allergy to eggs or egg products
• Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
• Family member with immunodeficiency
• Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
• Pregnant or breastfeeding

Where it is running

• Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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