Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: A/California/07/09 live monovalent H1N1 vaccine
Intervention description: 0.1mL per nares intranasally, second identical dose given 28 days after first vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 32 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Swine Flu; H1N1

Summary:

      The purpose of the study is to determine the amount of live virus that can be recovered from
      the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to
      describe the immune response to vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-32 years, inclusive

          -  No history of Novel H1N1 virus or vaccine

          -  Female not able to bear children or not pregnant and agrees to practice effective
             birth control

          -  Female negative pregnancy test

          -  Good Health

          -  Ability to understand and comply with protocol

          -  Provided Informed Consent

        Exclusion Criteria:

          -  Previous history of vaccination against novel H1N1 or laboratory documented H1N1
             infection

          -  History of egg allergy or is allergic to other components of the vaccine

          -  A women who is pregnant or breastfeeding or intends to get pregnant during the study
             period between enrollment and 30 days following vaccination

          -  Subject is immunosuppressed as the result of underlying illness or treatment with
             immunosuppressive or cytotoxic drugs or use of chemotherapy or radiation therapy in
             the preceding 36 months

          -  Subject has active neoplastic disease (excluding non-melanoma skin cancer or prostate
             cancer that is stable in the absence of therapy) or a history of any hematological
             malignancy. "active is defined as treatment within the past 5 years

          -  Long term (greater than 2 weeks) use of oral or parental steroids, or high- dose
             inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within
             the preceding 6 months (nasal and topical steroids allowed)

          -  Received immunoglobulin or another blood product within 3 months prior to enrollment
             in this study

          -  Subject has received an inactivated vaccine within 2 weeks or a live vaccine within 4
             weeks prior to enrollment in this study or plans to receive another vaccine within the
             next 28 days (or 56 days for the vaccine naive recipients)

          -  Subject 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. Those conditions include chronic conditions recognized as risk factors
             for influenza complications or as contraindicated for live vaccination, including
             chronic cardiac (exclusive of hypertension) or pulmonary conditions (including
             asthma), diabetes mellitus, or renal impairment

          -  Subject has an acute illness or an oral temperature greater then 99.9 degrees F(37.7
             C)within 3 days prior to enrollment or vaccination. Subject who has acute illness that
             was treated, symptoms resolved are eligible to enroll as long as treatment is complete
             and symptoms resolved > 3 dyas prior to enrollment.

          -  Subject is currently participating or plans to participate in a study that involves an
             experimental agent (vaccine, drug, biologic, device, blood product, or medication) or
             has received an experimental agent within 1 month prior to enrollment in this study,
             or intends to donate blood during this period.

          -  Subject 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

          -  Subject has a history of alcohol or drug abuse in the 5 years prior to enrollment.

          -  Subject has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.

          -  Subject has a previous history of Guillain-Barre syndrome within 6 weeks of receipt of
             influenza vaccine

          -  Subject has any condition that the principal investigator (PI) believes may interfere
             with the successful completion of the study