Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study A)
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 purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults. Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide variety of birds and mammals. The direct transmission of avian influenza viruses from birds to humans has recently become a major health concern in Asia and other parts of the world, raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live attenuated virus vaccine administered intranasally for the protection of humans against pandemic influenza viruses of the H9N2 subtype.
Key facts
- Study ID
- NCT00110279
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 30
- Starts
- 2005-06-01
- Expected to finish
- 2005-09-01
- 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 trial
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
- Liver, renal, or hematologic disease
- Alcohol or drug abuse within 12 months of 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 30 days prior to study entry
- Have traveled on a cruise ship within 30 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
Where it is running
- Johns Hopkins School of Public Health — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.