Safety and Immunogenicity of Live Influenza A Vaccine for Avian Influenza H7N7

Completed · Phase 1

Conditions studied: Influenza A

In brief

Every year the human population suffers from seasonal outbreaks of influenza resulting in both illness and death. However, the rates of illness and death from seasonal outbreaks are significantly lower than those suffered during times of influenza pandemic, such as those experienced in 1918, 1957, and 1968. The reason for this difference lies in presence of immunity within a population. With seasonal outbreaks of influenza most people have some immunity to the circulating strain and usually only those with weakened immune systems experience serious complications. Influenza pandemics, in contrast, are the result of a completely new viral subtype to which nobody possesses an immunity, leaving everyone vulnerable to the most serious of complications. It has been estimated that the next flu pandemic could cause over 200,000 deaths and over 700,000 hospitalizations in the US alone. The need for an effective viral vaccine is high. The purpose of this study is to test the safety and immunogenicity of a live influenza A strain vaccine, which would be able to combat an influenza pandemic.

Key facts

Study ID

NCT00922259

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

25

Starts

2010-07-01

Expected to finish

2012-01-01

Last updated by the study team

2013-02-13

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to provide informed consent
• 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
• 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 study protocol.
• Agrees to store blood specimens for future research

You may not qualify if…

• Pregnancy or breast-feeding
• 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 ALT levels, as determined by the Principal Investigator, 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 protocol
• Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H7N7 influenza A virus (serum HI titer greater than 1:8)
• Positive urine drug toxicology test indicating narcotic use or dependency
• Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
• History of anaphylaxis
• Allergy to oseltamivir
• Diagnosis of asthma or reactive airway disease within the past 2 years
• History of Guillain-Barre Syndrome
• Positive ELISA and confirmatory Western blot tests for HIV-1
• Positive ELISA and confirmatory test (for example, recombinant immunoblot assay [RIBA]) for hepatitis C virus (HCV)
• Positive test for 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 study 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
• Current involvement with the poultry industry. This refers to direct contact with poultry within the 14 days prior to the study or after the study completion.
• Receipt of another investigational vaccine or drug within 30 days prior to study vaccination

Where it is running

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

Full record on ClinicalTrials.gov

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