Status:
COMPLETED
St. Jude Open Label H5 Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to see how antibodies (proteins that fight infection) are made after you receive the new H5N1 flu vaccine. The new H5N1 vaccine will be given to 50 healthy adult lab worke...
Detailed Description
The purpose of this open-label, phase I/II study is to investigate the safety and immunogenicity of two 90-mcg doses of intramuscular inactivated influenza A/H5N1 vaccine in healthy adults, aged 18 ye...
Eligibility Criteria
Inclusion
- Laboratory personal with potential exposure to live H5N1 viruses.
- Male or nonpregnant female (as indicated by a negative urine pregnancy test prior to each dose of vaccine), aged 18 years and older.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.
- Is in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
Exclusion
- Has a known allergy to eggs or other components of the vaccine.
- Has a known allergy or sensitivity to latex (in the stopper).
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 6-month study period.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00311675
Start Date
April 1 2006
End Date
December 1 2006
Last Update
August 27 2010
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 31805