Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)
Condition: Influenza A Virus, H5N1 Subtype
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: H5N1 vaccine plus AS03 adjuvant; H5N1 vaccine without adjuvant
Intervention description: Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart.; Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant.
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza A (H5N1) virus; H5N1 influenza; influenza A/H5/N1; monovalent H5N1 influenza vaccine; systems biology; AS03 adjuvant; unadjuvanted

Summary:

      This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent
      Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine
      with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by
      the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are
      approved for use in the United States. The results of this study will help researchers learn
      about better ways to vaccinate people against the H5N1 flu.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals in good health (as determined by vital signs, medical history, physical
             examination and laboratory tests);

          -  Able to understand and give informed consent;

          -  Women of childbearing potential must agree to practice adequate contraception 1 month
             prior to study entry and until day 100 of the study.

        Exclusion Criteria:

          -  Personal or family history of sleeping disorders including any of the following:
             Narcolepsy with or without cataplexy; Idiopathic Hypersomnia or excessive daytime
             sleepiness of unknown origin; Sleep paralysis; Sleep related hallucinations
             (hypnagogic or hypnopompic hallucinations);

          -  Human leukocyte antigen (HLA)-DQB1*06:02 positivity (or DQB1*06 positivity if high
             resolution HLA testing cannot be performed);

          -  An abnormal erythrocyte sedimentation rate at baseline;

          -  Receipt of blood products 3 months prior to study entry and until day 100 of the
             study;

          -  Volunteers who donated blood 56 days before screening and have plans to donate on or
             before day 100 of the study;

          -  Hemoglobin value of less than 12 mg/dL for females and less than 13 mg/dL for males;

          -  A positive result in the Narcolepsy Mini Screen questionnaire;

          -  A score of ≥11 on the Epworth sleepiness scale questionnaire;

          -  Receipt of any experimental agents within 6 weeks prior to first vaccination and until
             the completion of the study;

          -  Receipt of any licensed live vaccine within 4 weeks or any licensed inactivated
             vaccine within 2 weeks prior to the first study vaccination or planned receipt of any
             vaccine within 42 days after study entry;

          -  Receipt of a H5 vaccine or AS03-adjuvanted vaccine at any time in the past prior to
             current study or have a history of A/H5N1 infection;

          -  Influenza-like illness (ILI) or documented influenza infection during the 2013-2014
             influenza season. [Not excluded from the study, volunteers with prior upper
             respiratory infections other than ILI];

          -  Chronic medical problems including (but not limited to) insulin dependent diabetes,
             severe heart disease, severe lung disease, severe liver disease, severe kidney
             disease, autoimmune disease, severe gastrointestinal disease;

          -  Alcohol or drug abuse and psychiatric conditions that in the opinion of the
             investigator would preclude compliance with the trial or interpretation of safety or
             endpoint data;

          -  Impaired immune function or chronic infections including (but not limited to) HIV,
             hepatitis B or C; organ transplant; active cancer or any history of hematologic
             cancer; receipt of chemotherapy, radiation therapy (past 36 months) or any other
             potentially immunosuppressive therapy [i.e. Systemic steroids at any dose and
             intra-articular administration of steroids in the past 3 months; (Nasal and topical
             steroids are allowed)], congenital immunodeficiency, anatomical or functional
             asplenia;

          -  Heart rate less than 40 bpm or greater than 100 bpm. Systolic blood pressure is less
             than 90 mm Hg or equal or greater than 160 mm Hg. Diastolic blood pressure is less
             than 60 mm Hg or equal or greater than 100 mg Hg;

          -  Pregnancy or postpartum (less than 1 year after delivery) or breast feeding;

          -  Severe reactions to prior vaccination with influenza virus vaccines, including
             anaphylaxis;

          -  History of Guillain-Barré syndrome;

          -  A previous sudden life-threatening allergic reaction to any ingredient of Influenza A
             (H5N1) Virus Monovalent Vaccine with or without AS03 adjuvant or to any of the
             substances that may be present in trace amounts such as thiomersal, egg residues
             including ovalbumin as well as residual amounts of sodium deoxycholate detergent,
             formaldehyde and sucrose;

          -  Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0 C],
             regardless of the route) within 3 days prior to study entry;

          -  Social, occupational, or any other condition that in the opinion of the investigator
             might interfere with compliance with the study and vaccine evaluation.