CompletedPhase 1

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

United States25 participantsStarted 2010-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 inve…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Immunogenicity as measured by Anti-H7N7 antibody and seroconversion

Timeframe: Measured on Days 2 to 9 and 26 to 37

Determine the frequency of vaccine-related reactogenicity events (REs) and other adverse events (AEs) for 2 doses of vaccine

Timeframe: Measured on Days 2 to 9 and 26 to 37

Trial details

NCT IDNCT00922259

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-01

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