Group Study of the Safety of and Immune Response to a Single Dose of 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 that infect people is important. The purpose of this study is to determine the safety of and immune response of an investigational AI vaccine in healthy adults against the H7N3 strain of avian influenza.

Key facts

Study ID

NCT00853255

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Starts

2010-07-01

Expected to finish

2011-12-01

Last updated by the study team

2013-01-03

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
• 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.

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.
• 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

Where it is running

• University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital — Rochester, New York, United States

Full record on ClinicalTrials.gov

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