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.
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.
