Safety Study of Avian Flu Vaccine (NCT00408109) | Clinical Trial Compass
CompletedPhase 1
Safety Study of Avian Flu Vaccine
United States45 participantsStarted 2006-12-04
Plain-language summary
This study will determine if an experimental avian flu (bird flu) vaccine is safe, whether it has side effects and if it can stimulate an immune response in people. The vaccine being tested in this study is made from DNA (genetic material) that codes for an influenza protein called hemagglutinin 5 (H5), which is based on the protein from the bird flu virus. The study will determine if the body creates resistance or immunity to the H5 protein. The hope is that an immune response to this protein may protect against bird flu virus infection.
Healthy people between 18 and 60 years old who have been vaccinated with the current season's influenza vaccine may be eligible for this study.
Participants are randomly assigned to receive injections of one of the following: 1) study vaccine at 1 mg dose, 2) study vaccine at 4 mg dose, or 3) placebo (salt-water solution). They receive three injections about 4 weeks apart in the upper arm muscle. Participants record their temperature and symptoms at home for 5 days after each injection, either on a diary card or electronically using the Internet, and report any side effects to a study physician or nurse as soon as possible. They return to NIH for clinic visits every 2 weeks for the first 12 weeks, then at week 26 and at week 42 to check for health changes or problems. Blood is drawn at all visits and urine samples are collected through week 10.
If a participant develops serious side effects, the study physician may decide that he or she should not receive any further injections. However, all participants are asked to continue the follow-up visits even if they do not get the full set of three injections.
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Who can participate
Age range
18 Years – 60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 60 years old.
. Available for clinical follow-up through Week 42.
. Immunized with the current season FDA-approved influenza vaccine prior to enrollment at the specified interval \[14 days to 24 weeks prior to enrollment for the inactivated influenza vaccine OR 30 days to 24 weeks prior to enrollment for the live-attenuated influenza vaccine (FluMist)\].
. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
. Able and willing to complete the informed consent process.
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
1
Safety (local and systemic reactogenicity, lab tests, AEs)
Trial details
NCT IDNCT00408109
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Willing to donate blood for sample storage to be used for future research.
. In good general health without clinically significant medical history.
Exclusion criteria
. Breast-feeding or planning to become pregnant during the study.
. Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. \[With the exceptions that use of corticosteroid nasal spray for rhinitis; topical corticosteroids for an acute uncomplicated dermatitis; short-acting beta-agonist use in controlled asthmatics; or a short course (10 days or less) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
. Blood products within 120 days prior to HIV screening.
. Immunoglobulin within 60 days prior to HIV screening.
. Live attenuated vaccines within 30 days prior to initial study vaccine administration.
. Investigational research agents within 30 days prior to initial study vaccine administration.
. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.