Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: LAIV H2N2; Placebo
Intervention description: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28; placebo delivered intranasally. .25cc to each nostril at day 0 and day 28
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H2N2; vaccine

Summary:

      This is a phase I study to evaluate the safety of a vaccine to protect against influenza
      viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of
      vaccine or placebo one month apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Legal male or female adult aged 18 through 40 years

          -  Literate and willing to provide written informed consent.

          -  A signed informed consent.

          -  Free of obvious health problems, as established by medical history and screening
             evaluations, including physical examination.

          -  Capable and willing to complete diary cards and willing to return for all follow-up
             visits

          -  Willing to comply with the rules of isolation unit (including willing and able to take
             oseltamivir influenza antiviral medication, should that be recommended by study
             physician).

          -  For females, willing to take reliable birth control measures through day 56.

        Exclusion Criteria:

          -  Participation in another clinical trial involving any therapy within the previous
             three months or planned enrollment in such a trial during trial period.

          -  Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to
             postpone receipt of such vaccines until four weeks after study completion.

          -  Practice of nasal irrigation on a regular basis within the past six months or has
             engaged in nasal irrigation within two weeks prior to enrollment.

          -  Recent history of frequent nose bleeds (>5 within the past year).

          -  Clinically relevant abnormal paranasal anatomy.

          -  Recent history (within the past month) of rhino or sinus surgery, or surgery for any
             traumatic injury of the nose.

          -  Current or recent (within two weeks of enrollment) acute respiratory illness with or
             without fever.

          -  Other acute illness at the time of study enrollment.

          -  Receipt of immune globulin or other blood products within three months prior to study
             enrollment or planned receipt during period of subject participation in the study.

          -  Chronic administration (defined as more than 14 consecutively-prescribed days) of
             immunosuppressants and/or other immune-modulating therapy within six months prior to
             study enrollment.

          -  Participation in any previous trial of any H2N2 containing influenza vaccine.

          -  History of asthma.

          -  Hypersensitivity after previous administration of any influenza vaccine.

          -  History of wheezing after past receipt of any live influenza vaccine.

          -  Other adverse event (AE) following immunization (body temperature more than 40°C,
             collapse, non-febrile seizures, anaphylaxis), at least possibly related to previous
             receipt of any vaccine (not only influenza).

          -  Suspected or known hypersensitivity to any study vaccine components, including chicken
             or egg protein.

          -  Seasonal (autumnal) hypersensitivity to the natural environment

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic,
             neurologic, psychiatric or renal functional abnormality, as determined by medical
             history, physical examination or clinical laboratory screening tests, which in the
             opinion of the investigator, might interfere with the study objectives. Subjects with
             physical examination findings or clinical laboratory screening results which would be
             graded 2 or higher on the AE severity grading scale (see Attachments) will be excluded
             from entry into the study and will be excluded from receipt of dose two of study
             vaccine or placebo.

          -  History of leukemia or any other blood or solid organ cancer.

          -  History of thrombocytopenic purpura or known bleeding disorder.

          -  History of seizures.

          -  Known or suspected immunosuppressive or immunodeficient condition of any kind,
             including HIV infection.

          -  Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

          -  Known tuberculosis infection or evidence of previous tuberculosis exposure.

          -  History of chronic alcohol abuse and/or illegal drug use.

          -  Claustrophobia or sociophobia.

          -  Pregnancy or lactation.

          -  Any condition that, in the opinion of the investigator, would increase the health risk
             to the subject if participates in the study or would interfere with the evaluation of
             the study objectives.

          -  Allergic, including anaphylactic, reactions to the introduction of any vaccines (not
             only influenza) in the subject's medical history