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 range18 Years ā 60 Years
SexALL
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Inclusion criteria
ā. 18 to 60 years old.
ā. Available for clinical follow-up through Week 42.
ā. Immunized with the current season FDA-approved influenza vaccine prior to enrollment at the specified interval \[14 days to 24 weeks prior to enrollment for the inactivated influenza vaccine OR 30 days to 24 weeks prior to enrollment for the live-attenuated influenza vaccine (FluMist)\].
ā. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
ā. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
ā. Able and willing to complete the informed consent process.
ā. Willing to donate blood for sample storage to be used for future research.
ā. In good general health without clinically significant medical history.
Exclusion criteria
ā. Breast-feeding or planning to become pregnant during the study.
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)
ā. Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. \[With the exceptions that use of corticosteroid nasal spray for rhinitis; topical corticosteroids for an acute uncomplicated dermatitis; short-acting beta-agonist use in controlled asthmatics; or a short course (10 days or less) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
ā. Blood products within 120 days prior to HIV screening.
ā. Immunoglobulin within 60 days prior to HIV screening.
ā. Live attenuated vaccines within 30 days prior to initial study vaccine administration.
ā. Investigational research agents within 30 days prior to initial study vaccine administration.
ā. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.