Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)

Completed · Phase 1

Conditions studied: Influenza, Virus Diseases

In brief

Avian influenza (AI), also known as bird flu, has become a major public health concern in many regions of the world. The purpose of this study is to evaluate the safety of and immune response to an AI vaccine in healthy adults.

Key facts

Study ID

NCT00380237

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Starts

2006-10-01

Expected to finish

2007-01-01

Last updated by the study team

2008-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Born after 1968
• Good general health
• Available for the duration of the study
• Female participants must agree to use acceptable forms of contraception

You may not qualify if…

• Significant medical illness, physical examination findings, or urine or blood abnormalities
• Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
• Previously enrolled in an H9N2 influenza vaccine study or in any other study of a bird flu vaccine
• Positive for the H9N2 influenza A virus (serum hemagglutination inhibiting [HI] factor antibody titer greater than 1:8)
• Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry
• History of severe allergic reaction or anaphylaxis
• Current asthma or reactive airway disease within 2 years prior to study entry
• History of Guillain-Barre syndrome
• HIV-1 serotype positive
• Hepatitis C virus (HCV) positive
• Hepatitis B surface antigen positive
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical corticosteroids are not excluded.
• Live vaccine within 4 weeks prior to study entry
• Killed vaccine within 2 weeks prior to study entry
• Absence of spleen
• Blood products within 6 months prior to study entry
• Current smoker unwilling to stop smoking for the duration of the study
• Plans to travel to the Southern Hemisphere or Asia within 14 days prior to study entry
• Plans to travel on a cruise ship within 14 days prior to study entry
• Work in the poultry industry
• Received an investigational agent within 30 days prior to study entry
• Allergy to eggs or egg products
• Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)

Where it is running

• Center for Immunization Research Inpatient Unit, Mason F. Lord Building, Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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