Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent inactivated influenza virus vaccine (2006-2007 formulation); Type 1 interferon
Intervention description: Commercially available trivalent inactivated influenza virus vaccine without or with 1 of 2 dosages of commercially available type 1 interferon administered once by nasal instillation. Dosages: 0.6 ml of IVV or 0.7 ml of IVV.; Commercially available lyophilized IFN; dosages 1 M unit (Mu) of IFN; 10 M units (Mu) of IFN.
Intervention MeSH terms: Interferons
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: interferon, vaccine, influenza

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 effective. This study will determine if type 1 interferon added to a specific
      flu vaccine will help the immune system of healthy adults fight off infection better than
      vaccine alone. Ninety volunteers, ages 18-40, will participate in this study. They will
      attend 3 study visits and have a final follow-up study visit, email, or phone call about six
      months after the vaccination. Volunteers will receive a single dose of study vaccine sprayed
      into the nose. Study procedures including blood samples and nasal washes (the inside of the
      nose is washed out) will be collected to evaluate immune system responses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.