Status:
COMPLETED
Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Influenza
Virus Diseases
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
AI viruses in their natural reservoir in waterfowl are the source from which novel HA and NA subtypes are introduced into the human population, and have the potential to initiate an influenza pandemic...
Eligibility Criteria
Inclusion
- Good general health
- Available for the duration of the trial
- Willing to use acceptable forms of contraception
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00347672
Start Date
June 1 2006
End Date
July 1 2007
Last Update
January 21 2008
Active Locations (1)
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1
Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205