Status:
COMPLETED
Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Influenza
Virus Diseases
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next infl...
Detailed Description
H6 influenza viruses are of the low pathogenicity phenotype in poultry, and in the last decade, outbreaks of H6 influenza infection have been reported both in the United States and South Africa. The p...
Eligibility Criteria
Inclusion
- Adult males and non-pregnant females 18-49 years old
- General good health
- Available for the duration of the trial
- If female, agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol.
Exclusion
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
- Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
- Previous enrollment in an H6N1 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H6N1 influenza A virus (serum HAI titer \>1:8)
- Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency
- Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry
- Any condition that, in the opinion of the investigator, would interfere with the study
- History of anaphylaxis
- Allergy to oseltamivir as determined by subject report
- Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry
- History of Guillain-Barre Syndrome
- HIV-1-infected
- Hepatitis C-infected
- Positive hepatitis B virus surface antigen
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry
- History of a surgical splenectomy
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry
- Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol.
- Travel to the Southern Hemisphere within 14 days prior to study entry
- Travel on a cruise ship within 14 days prior to study entry
- Direct contact with live poultry within the 14 days prior to the study or after study completion.
- Receipt of another investigational vaccine or drug within 30 days prior to study entry
- Allergy to eggs or egg products
- Pregnant or breastfeeding
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00734175
Start Date
September 1 2008
Last Update
August 7 2009
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building
Baltimore, Maryland, United States