Status:
COMPLETED
Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)
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+ years
Phase:
PHASE1
Brief 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...
Detailed Description
AI is caused by a virus that occurs naturally among birds. Because the virus has the ability to mutate into a form that can efficiently spread among the human population, AI has the potential to cause...
Eligibility Criteria
Inclusion
- Born after 1968
- Good general health
- Available for the duration of the study
- Female participants must agree to use acceptable forms of contraception
Exclusion
- 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)
- Family member with immunodeficiency
- Other condition that, in the opinion of the investigator, would affect participation in the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00380237
Start Date
October 1 2006
End Date
January 1 2007
Last Update
January 21 2008
Active Locations (1)
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1
Center for Immunization Research Inpatient Unit, Mason F. Lord Building, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224