Evaluation of the Safety and Immunogenicity of a Live Attenuated Virus Vaccine for the Prevention of H2N3 Influenza

Completed · Phase 1

Conditions studied: Influenza A Virus Infection

In brief

In recent years, influenza viruses that have traditionally infected animals have infected humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United States in 2006, may pose a potential health concern to humans. This study will evaluate the safety of and immune response to a vaccine designed to protect people from the H2N3 influenza virus.

Key facts

Study ID

NCT01175122

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Starts

2010-09-01

Expected to finish

2011-04-01

Last updated by the study team

2013-02-11

Who can join

Age: 18 and older, up to 42. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In general good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
• Agree to storage of blood specimens for future research
• Available for the duration of the trial
• Willing to participate in the study as evidenced by signing the informed consent document
• 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.

You may not qualify if…

• Pregnant or 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. Clinically significant alanine aminotransferase (ALT) levels, as determined by the principal investigator (PI), will be exclusionary at baseline, prior to vaccination.
• 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 procedures
• Previous enrollment in an H2 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H2N3 influenza A virus (serum HAI titer greater than 1:8)
• Positive urine drug toxicology test indicating narcotic use/dependency
• 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 person participating in the trial or would render the person unable to comply with the study procedures
• History of anaphylaxis
• Allergy to oseltamivir as determined by participant report
• Current diagnosis of asthma or reactive airway disease (within the 2 years prior to study entry)
• History of Guillain-Barré Syndrome
• Positive ELISA and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1)
• Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
• Positive hepatitis B virus surface antigen (HBsAg) by ELISA
• Known immunodeficiency syndrome
• Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
• Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
• History of a surgical splenectomy
• Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
• 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 vaccination
• Travel on a cruise ship within 14 days prior to study vaccination
• Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
• Allergy to eggs or egg products

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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