Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: LAIV H5N2; Placebo
Intervention description: 2 doses provided intranasally; 2 doses of placebo provided intranasally
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: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; vaccine; pandemic

Summary:

      To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133
      (H5N2) in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Legal male or female adult 18 through 49 years of age at the enrollment visit.

          -  Literate and willing to provide written informed consent.

          -  Free of obvious health problems, as established by the 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 the isolation unit (including willing and able to
             take oseltamivir influenza antiviral medication, should that be recommended by a study
             physician).

          -  For females, willing to take reliable birth control measures throughout the entire
             period of participation in the study.

        Exclusion Criteria:

          -  Participation in another clinical trial involving any therapy within the previous
             three months or planned enrollment in such a trial during the period of this study.

          -  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 of such products during the period of subject
             participation in the study.

          -  Chronic administration (defined as more than 14 consecutively-prescribed days) of
             immunosuppressants or other immune-modulating therapy within six months prior to study
             enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg
             per day; topical steroids are allowed, exclusive of nasal.)

          -  Participation in any previous trial of any H5 or H7 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, at least possibly related to previous
             receipt of any influenza vaccine.

          -  Suspected or known hypersensitivity to any of the 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 (HBV) or hepatitis C (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. (A negative pregnancy test will be required before
             administration of study vaccine or placebo for all women of childbearing potential.)

          -  Any condition that, in the opinion of the investigator, would increase the health risk
             to the subject if he/she participates in the study or would interfere with the
             evaluation of the study objectives