Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in H… (NCT00853255) | Clinical Trial Compass
CompletedPhase 1
Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults
United States20 participantsStarted 2010-07
Plain-language summary
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.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* 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.
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
* 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…
What they're measuring
1
Frequency of vaccine-related reactogenicity events
Timeframe: During inpatient stage
2
Area under the curve of nasal viral shedding
Timeframe: Days 2 through 9
3
Development of serum antibody assessed by either HAI or MN assays
Timeframe: Throughout study
Trial details
NCT IDNCT00853255
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)