Immunogenicity of H5N1 Vaccine Following H5N2
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Intervention: A(H5N1) inactivated influenza vaccine (IIV); A(H5N2) live attenuated influenza vaccine (LAIV)
Intervention description: Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.; Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LAIV H5N2; Influenza vaccine; Russia

Summary:

      This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can
      induce a long-lasting immune memory by comparing the immunologic response to two doses of the
      OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who
      did not received LAIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Legal male or female adult 18 through 51 years of age at the enrollment visit

          -  Literate and willing to provide written informed consent

          -  A signed informed consent

          -  Free of obvious health problems, as established by the medical history and screening
             evaluations, including physical examination

          -  Capable and willing to complete a memory aid and willing to return for all follow-up
             visits

          -  For females, willing to take reliable birth control measures through Day 56

        Exclusion Criteria:

          -  Participation in another clinical trial involving any investigational agent 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

          -  Participation in any other clinical trials involving any H5-matched influenza vaccines
             except that in Protocol LAIV-H5N2-01

          -  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 immunoglobulin or other blood products within three months prior to study
             enrollment or planned receipt during study period

          -  Chronic administration (defined as more than 14 consecutively-prescribed days) of
             immunosuppressants and/or immune-modulating therapy within six months prior to study
             enrollment

          -  History of bronchial asthma

          -  Hypersensitivity after previous administration of any (not only influenza) vaccines.

          -  Other adverse event (AE) following immunization at least possibly related to previous
             receipt of any (not only influenza) vaccine

          -  Suspected or known hypersensitivity to any of the study vaccine components, including
             protein of chicken eggs

          -  Seasonal (autumnal) hypersensitivity to the natural environment

          -  Acute or chronic clinically significant 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 will be excluded from entry into the study

          -  History of leukemia or any other blood diseases 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 (HCV) infection

          -  Known tuberculosis infection or evidence of previous tuberculosis exposure

          -  History of chronic alcohol abuse and/or illegal drug use

          -  Pregnancy or lactation.

               -  Systemic connective tissue disorders

          -  Adrenal gland diseases

          -  Hereditary, degenerative and progredient diseases of the nervous system

          -  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

          -  Allergic, including anaphylactic, reactions to any (not only influenza) vaccines