Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
• Have family member with immunodeficiency-related condition
• Other condition that, in the opinion of the investigator, may interfere with the study
• Pregnancy or breastfeeding