Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B) (NCT00380237) | Clinical Trial Compass
CompletedPhase 1
Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)
United States20 participantsStarted 2006-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Born after 1968
* Good general health
* Available for the duration of the study
* Female participants must agree to use acceptable forms of contraception
Exclusion Criteria:
* 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
* Cu…
What they're measuring
1
Safety, as defined by frequency of vaccine-related reactogenicity events and other adverse events (AEs) for each dose
Timeframe: Throughout study
2
Immunogenicity, as determined by antibody to H9N2
Timeframe: At Days 0, 28, and 42
3
Determining the amount of serum and nasal wash antibody induced by the vaccine
Timeframe: Throughout study
Trial details
NCT IDNCT00380237
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)