Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1
Condition: Influenza A Subtype H5N1 Infection
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: IVACFLU-A/H5N1, 7.5 mcg; IVACFLU-A/H5N1, 15 mcg; Placebo Comparator
Intervention description: Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.; Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose; PBS, pH 7.2 in 0.5 mL single-dose vials.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Avian; H5N1; Vaccine

Summary:

      This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole
      cell vaccine when given in two injections in two doses (low and high) compared to a placebo
      in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in
      Vietnam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult 18 through 30 years of age at the enrollment visit.

          -  Literate and willing to provide written informed consent.

          -  Healthy adults, 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.

          -  For females, willing to utilize reliable birth control measures (intrauterine device,
             hormonal contraception, condoms) through the Day 42 visit

        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 after the Day 42 visit.

          -  Current or recent (within two weeks of enrollment) acute illness with or without
             fever.

          -  Receipt of immune globulin or other blood products within three months prior to study
             enrollment or planned receipt of such products prior to the Day 42 visit.

          -  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.)

          -  History of asthma.

          -  Hypersensitivity after previous administration of any vaccine.

          -  Other AE following immunization, at least possibly related to previous receipt of any
             vaccine.

          -  Suspected or known hypersensitivity to any of the study vaccine components, including
             chicken or egg protein.

          -  Known hypersensitivities (allergies) to food or the natural environment.

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary,
             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.

          -  History of any blood or solid organ cancer.

          -  History of thrombocytopenic purpura or known bleeding disorder.

          -  History of seizures.

          -  Known or suspected immunosuppressed or immunodeficient condition of any kind.

          -  Known chronic HBV or HCV infection.

          -  Known active tuberculosis or symptoms of active tuberculosis, regardless of cause.

          -  History of chronic alcohol abuse and/or illegal drug use.

          -  Pregnancy or lactation. (A negative pregnancy test will be required before
             administration of study product for all women of childbearing potential.)

          -  History of Guillain-Barré Syndrome

          -  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.