Status:
COMPLETED
Evaluating the Safety and Immune Response to an H5N1 Influenza Vaccine in People Who Have Previously Received an H5N1 or H7N3 Influenza Vaccine and in People Who Have Never Received a Live Attenuated Influenza Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
H5N1 Influenza
Eligibility:
All Genders
22-54 years
Phase:
PHASE1
Brief Summary
H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have previously rec...
Detailed Description
Avian influenza viruses, including H1N1 and H5N1, are capable of causing an influenza pandemic. The 2009 H1N1 pandemic caused approximately 10,000 deaths in the United States, and H1N1 and H5N1 influe...
Eligibility Criteria
Inclusion
- In general good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
- Available for the duration of the trial
- Willing to participate in the study as evidenced by signing the informed consent document
- Willing to allow storage and testing of laboratory samples for future research
- Received two doses of live attenuated H5N1 or H7N3 vaccine in a prior trial (Study Groups 1, 2, and 3) or LAIV and H5 naïve (Study Groups 4 and 5)
- Willing to forego seasonal LAIV for the duration of the trial (until 6 months after the last vaccination)
- Female participants must 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
- Pregnant, as determined by a positive beta-human choriogonadotropin (HCG) test
- Currently breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the 12 months prior to study entry
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- History of anaphylaxis
- History of life-threatening reaction to prior influenza vaccine
- Current diagnosis of asthma or reactive airway disease (within the 2 years prior to study entry)
- Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory Western blot tests for HIV-1
- Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay \[RIBA\]) for hepatitis C virus (HCV)
- Positive hepatitis B virus surface antigen (HBsAg) by ELISA
- Known immunodeficiency syndrome
- History of Guillain-Barré syndrome
- Use of chronic oral or intravenous administration (greater than or equal to 14 days) of immunosuppressive doses of steroids, i.e., prednisone greater than 10 mg per day, immunosuppressants or other immune-modifying drugs within 30 days of starting this study
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
- Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
- Allergy to eggs or egg products
- In addition to the above, participants in the H5 and LAIV-naïve groups must also not experience any of the following:
- Previous enrollment in an H5 influenza vaccine trial or in any study of an avian influenza (AI) vaccine
- Seropositive to the H5N1 influenza A virus (serum HI titer greater than 1:8)
- Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01443663
Start Date
October 1 2011
End Date
March 1 2013
Last Update
February 9 2016
Active Locations (1)
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1
Centers for Immunization Research (CIR) - John Hopkins Bloomburg School of Public Health
Baltimore, Maryland, United States, 21205