Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults (NCT00347672) | Clinical Trial Compass
CompletedPhase 1
Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
United States42 participantsStarted 2006-06
Plain-language summary
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.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* Good general health
* Available for the duration of the trial
* Willing to use acceptable forms of contraception
Exclusion Criteria:
* 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 …
What they're measuring
1
Frequency of vaccine-related reactogenicity events
Timeframe: During the acute monitoring phase of the study
2
Anti-H5N1 antibody levels and seroconversion, defined as a greater than fourfold rise in serum hemagglutination inhibiting (HI) and/or neutralizing antibody titer compared to Day 0
Timeframe: Throughout study
Trial details
NCT IDNCT00347672
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)