Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) 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 a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults.

Key facts

Study ID

NCT00488046

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

16

Starts

2007-06-01

Expected to finish

2007-09-01

Last updated by the study team

2007-11-20

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 study
• 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
• Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
• Previously enrolled in an H5N1 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H5N1 influenza A virus (serum hemagglutination inhibitor [HI] titer greater than 1:8)
• Illegal drug use or dependency determined by urine test
• 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 corticosteroid 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 or Asia 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 (CIR), Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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