Status:
COMPLETED
Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Virus Diseases
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains that infect people is important. The purpose of this ...
Detailed Description
The current pandemic risk associated with avian influenza H7N3 infection is significant, as an increasing number of humans are infected. H7 influenza transmission usually occurs in humans when they ar...
Eligibility Criteria
Inclusion
- Good general health
- Available for the duration of the trial
- For females, willing to use acceptable forms of contraception for the duration of the study. More information on this criterion can be found in the protocol.
Exclusion
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
- Previously enrolled in an H7N3 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H7N3 influenza A virus (serum hemagglutination inhibition \[HI\] titer greater than 1:8)
- Illegal drug use or dependency determined by urine test
- Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
- History of severe allergic reaction
- Allergy to oseltamivir
- Asthma or reactive airways disease within 2 years prior to study entry
- History of Guillain-Barre syndrome
- HIV-infected
- Hepatitis C virus infected
- Positive for hepatitis B surface antigen (HBsAg)
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded.
- Receipt of live vaccines within 4 weeks prior to study vaccination
- Receipt of killed vaccines within 2 weeks prior to study vaccination
- Absence of spleen
- Receipt of blood products within 6 months prior to study vaccination
- Current smoker unwilling to stop smoking for the duration of the study
- Have traveled to the Southern Hemisphere within 14 days prior to study vaccination
- Have traveled on a cruise ship within 14 days prior to study vaccination
- Work in the poultry industry within 14 days prior to or after study vaccination
- Other investigational vaccine or drug within 30 days prior to study vaccination
- Allergy to eggs or egg products
- Other condition that, in the opinion of the investigator, may interfere with the study
- Pregnant or breastfeeding
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00853255
Start Date
July 1 2010
End Date
December 1 2011
Last Update
January 3 2013
Active Locations (1)
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1
University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital
Rochester, New York, United States, 55902