Panblok H7 Vaccine Adjuvanted With AS03 or MF59
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: 3.75 ug Panblok H7; 7.5 ug Panblok H7; 15 ug Panblok H7; MF59; AS03
Intervention description: 0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.; Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.; Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.; 0.5 mL MF59 (39 mg squalene/mL ) adjuvant.; 0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of the six treatment groups at Day 1 and will receive the assigned dose of antigen and adjuvant on Day 1 and Day 29.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; human; Influenza in Birds; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; MF59; AS03; Adjuvants; Immunologic

Summary:

      The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza
      vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated
      by 28 days. Three different antigen dose levels of Panblok H7 will be tested.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first
             study vaccination.

          2. Provide written informed consent prior to the initiation of any study-related
             procedures.

          3. Are able to understand and comply with planned study procedures.

          4. Have a stable health status based on site investigator's clinical judgment, as
             established by physical examination, vital signs, and medical history.

          5. Have access to a consistent and reliable means of telephone contact, which may be in
             the home, workplace, or by personal mobile electronic device.

          6. Agree to stay in contact with the study site for the duration of the study, have no
             current plans to move from the study area, and agree to provide updated contact
             information as necessary.

        Exclusion Criteria:

          1. Have had a prior severe reaction to any influenza vaccine or have a known allergy to
             squalene-based adjuvants.

          2. Women who are pregnant or breast feeding. Women of childbearing potential must have a
             negative urine pregnancy test at screening and within 24 hours prior to each
             vaccination.

             Women of childbearing potential are defined as postmenarcheal and premenopausal
             females capable of becoming pregnant. This does not include females who meet any of
             the following conditions: menopausal >12 months, tubal ligation >12 months, bilateral
             salpingo-oophorectomy, or hysterectomy.

          3. Women of childbearing potential who refuse to use an acceptable method of birth
             control from screening to Day 50 (Visit 7) or, if sexually active with a male partner,
             who have not used a reliable birth control method during the 2 months prior to
             screening.

             Adequate contraception is defined as a contraceptive method with a failure rate of
             less than 1% per year when used consistently and correctly and when applicable, in
             accordance with the product label, for example: abstinence from penile-vaginal
             intercourse; oral contraceptives, either combined or progestogen alone; injectable
             progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring;
             percutaneous contraceptive patches; intrauterine device or intrauterine system; male
             partner sterilization at least 6 months prior to the female participant's Screening
             Visit, and this male is the sole partner for that participant (the information on the
             male partner's sterility can come from the site personnel's review of the participant
             medical records or interview with the participant on her medical history); male condom
             combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male
             condom combined with a female diaphragm, either with or without a vaginal spermicide
             (foam, gel, film, cream, or suppository).

          4. Have immunosuppression as a result of an underlying illness or treatment, or use of
             anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36
             months, or plans to receive immunosuppressive therapy/cytotoxic treatment during study
             participation.

          5. Have an active neoplastic disease or a history of any hematologic malignancy. However,
             participants with superficial skin cancer who do not require intervention other than
             local excision are not excluded.

          6. Have long-term use (≥14 consecutive days) of glucocorticoids including oral or
             parenteral prednisone or prednisone equivalent (>20 mg total dose per day) or
             high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent)
             within 1 month prior to screening in this study. However, participants on low-dose
             inhaled steroids (≤800 µg/day of beclomethasone dipropionate or equivalent) or topical
             steroids are not excluded.

          7. History of schizophrenia, bipolar disease, psychosis, or severe personality disorder.

          8. History of hospitalization for psychiatric illness, attempted suicide, or having been
             deemed a danger to self or others within the past 10 years.

          9. Have received immunoglobulin or other blood product (with the exception of Rho[D]
             immune globulin) within the 3 months prior to screening in this study.

         10. Have received any live vaccines within 4 weeks or inactivated or recombinant protein
             vaccines within 2 weeks prior to screening in this study or plan to receive such
             vaccines (including seasonal influenza vaccines) from screening through 21 days
             following the second dose of the study vaccine (Screening Visit through Day 50).

         11. Have an acute or chronic medical condition that, in the opinion of the site
             investigator, would render vaccination unsafe or would interfere with the evaluation
             of responses. This includes all PIMMCs such as Guillain Barré syndrome, narcolepsy,
             and current or history of autoimmune or chronic inflammatory disease.

         12. Have an acute illness, including body temperature greater than 100.4°F, at screening,
             immediately prior to each vaccination or, per participant report, within 3 days prior
             to each vaccination in this study.

         13. Received an experimental agent (vaccine, drug, biologic, device, blood product, or
             medication) within 1 month prior to screening in this study or expect to receive an
             experimental agent during the study period.

         14. Are participating or plan to participate in another interventional clinical trial
             (either active or follow up phase) during the study period.

         15. Participated in an A(H7) influenza vaccine study in the past or have a history of
             A(H7) influenza infection prior to vaccination in this study.

         16. Have known human immunodeficiency virus, hepatitis B, or hepatitis C infection (based
             on medical history).

         17. Have a history of alcohol or drug abuse in the last 5 years.

         18. Have a body mass index >35 kg/m2.

         19. Have a first degree relative with narcolepsy.

         20. Have any laboratory test result or clinical findings (including vital signs) that
             singly or in combination are likely to unfavorably alter the risk-benefit of
             participation or to confound study safety or immunogenicity results. participants
             cannot be rescreened based on abnormal laboratory test results.

         21. Alanine aminotransferase (AST) >2 times the upper limit of normal (ULN), or bilirubin
             >1.5 times the ULN unless isolated Gilbert's syndrome. participants cannot be
             rescreened based on abnormal laboratory test results.