Status:
COMPLETED
Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought that type 1 interferon (a protein that helps the immune system fight viruses) will make flu vaccines more ...
Detailed Description
Influenza is primarily a virus infection of the respiratory tract mucosa from the nose to the terminal bronchioles. Immunity to influenza virus infection is mediated primarily by antibody in respirato...
Eligibility Criteria
Inclusion
- Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (e.g., barrier method, abstinence, and licensed hormonal methods) for at least 3 months after immunization.
- Is in good health, as determined by vital signs (heart rate, 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, chicken protein or other components of the vaccine.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is lactating, or has the intention to become pregnant within 3 months of receipt of vaccine.
- 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 or other immunosuppressive or cytotoxic drugs.
- Has used any nasal or aerosol treatments in the past 2 weeks or likely to use any in the next 2 weeks.
- Has a diagnosis of hay fever or asthma.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week prior to vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in the study, or expects to receive an experimental agent during the 6-month study period.
- Is planning to enroll in another clinical trial at any time during the study period.
- Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.
- Has a history of alcohol or drug abuse in the last 5 years.
- Has a history of Guillain-Barre syndrome.
- Has received the 2006-2007 formulation influenza vaccine by injection or by nose drops (fall of 2006 or since).
- 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 :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00436046
Start Date
March 1 2007
End Date
October 1 2007
Last Update
June 13 2011
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030