Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
Influenza, Virus Diseases
About this trial
This is an interventional prevention trial for Influenza focused on measuring Bird Flu
Eligibility Criteria
Inclusion Criteria: Good general health Available for the duration of the trial Willing to use acceptable forms of contraception Exclusion Criteria: Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study Medical, work-related, or family problems as a result of alcohol or illicit drug use in the 12 months prior to study entry History of severe allergic reaction or anaphylaxis Current asthma or reactive airway disease History of Guillain-Barre syndrome HIV-1 infected Hepatitis C virus infected Positive for hepatitis B surface antigen (HBsAg) Known immunodeficiency syndrome Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical corticosteroids are not excluded. Live vaccine within 4 weeks of study entry Killed vaccine within 2 weeks of study entry Absence of spleen Blood products within 6 months of study entry Current smoker Have traveled to the Southern Hemisphere or Asia within 14 days prior to study entry Have traveled on a cruise ship within 14 days prior to study entry Work in the poultry industry Investigational agents within 60 days prior to study entry, or currently participating in another investigational vaccine or drug trial Allergy to eggs or egg products Purified protein derivative (PPD) positive (positive tuberculosis [TB] test) Family member with immunodeficiency Other condition that, in the opinion of the investigator, would affect the participant's participation in the study Pregnant or breastfeeding
Sites / Locations
- Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
1
2
3
Two vaccinations of H5N1 VN 2004/AA vaccine at the highest dose
One vaccination of H5N1 VN 2004/AA vaccine at a dose in-between the lowest and highest doses
One vaccination of H5N1 VN 2004/AA vaccine at the lowest dose