Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults

Completed · Phase 1

Conditions studied: Influenza, Virus Diseases

In brief

Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains infecting people is important. The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza.

Key facts

Study ID

NCT00516035

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

22

Starts

2007-09-01

Expected to finish

2007-12-01

Last updated by the study team

2015-05-18

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Good general health
• Available for the duration of the trial
• Willing to use acceptable forms of contraception for the duration of the study

You may not qualify if…

• 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.
• Live vaccines within 4 weeks prior to study vaccination
• Killed vaccines within 2 weeks prior to study vaccination
• Absence of spleen
• 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, Asia, or the United Kingdom 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
• Other investigational vaccine or drug within 30 days prior to study vaccination
• Allergy to eggs or egg products

Where it is running

• Center for Immunization Research Inpatient Unit, Mason F. Lord Building, 4940 Eastern Avenue — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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