Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
Condition: Norovirus Prevention
Intervention: Norovirus Bivalent VLP Vaccine; Placebo (Saline)
Intervention description: Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with or without MPL and/or aluminum hydroxide IM injection; Placebo-matching norovirus bivalent VLP vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 454.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like
      particle (VLP) vaccine for further development by assessing the rates of serious adverse
      events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs,
      Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from
      the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants aged 18 to 49 years of age at the time of enrollment.

          2. Are in good health at the time of entry into the trial as determined by medical
             history, physical examination and clinical judgment of the investigator.

          3. Participants with a signed informed consent form and any required privacy
             authorization prior to the initiation of any trial procedures and after the nature of
             the trial has been explained according to local regulatory requirements.

          4. Can comply with trial procedures and are available for the duration of the trial.

        Exclusion Criteria:

          1. Has a history of acute gastroenteritis within 14 days of enrollment.

          2. Has a clinically significant active infection (as assessed by the investigator) or
             oral body temperature 38°C (100.4°F) or higher within 3 days of the intended date of
             vaccination.

          3. Has received antipyretic/analgesic medications within 24 hours prior to the intended
             vaccine administration.

          4. Has known hypersensitivity or allergy to any of the bivalent norovirus virus-like
             particle (VLP) vaccine components (including excipients of the investigational
             vaccines).

          5. Has behavioral or cognitive impairment or psychiatric disease that, in the opinion of
             the investigator, may interfere with the participant's ability to participate in the
             trial.

          6. Has a history of any progressive or severe neurologic disorder, seizure disorder, or
             neuro-inflammatory disease (e.g., Guillain-Barré syndrome).

          7. Has history or any illness that, in the opinion of the investigator, might interfere
             with the results of the trial or pose additional risk to the participants due to
             participation in the trial.

          8. Has known or suspected impairment/alteration of immune function including the
             following:

               1. Chronic use of oral steroids (Equivalent to 20 mg/day prednisone for ≥ 12 weeks /
                  ≥2 mg/kg body weight /day for ≥ 2 weeks) within 60 days prior to Day 1 (use of
                  inhaled, intranasal, or topical corticosteroids is allowed).

               2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥ 12 weeks /
                  ≥2 mg/kg body weight /day for ≥2 weeks) within 60 days prior to Day 1.

               3. Receipt of immunostimulants within 60 days prior to Day 1.

               4. Receipt of parenteral, epidural, or intra-articular immunoglobulin preparation,
                  blood products, and/or plasma derivatives within 3 months prior to Day 1 or
                  planned during the full length of the trial.

               5. Receipt of immunosuppressive therapy within 6 months prior to Day 1.

               6. Human immunodeficiency virus (HIV) infection or HIV-related disease.

               7. Heritable immunodeficiency.

          9. Has abnormalities of splenic or thymic function.

         10. Has a history of any autoimmune disease.

         11. Has a known bleeding diathesis or any condition that may be associated with a
             prolonged bleeding time.

         12. Has any serious chronic or progressive disease according to judgment of the
             investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic
             disease).

         13. Has a body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg /
             [height in meters * height in meters]).

         14. Is participating in any clinical trial with another investigational product 30 days
             prior to first trial visit or intent to participate in another clinical trial at any
             time during the conduct of this trial.

         15. Participants who received any inactivated vaccines within 14 days or any live vaccines
             for 28 days prior to enrollment in this trial.

         16. Are first degree relatives of individuals involved in trial conduct.

         17. Has a history of substance or alcohol abuse within the past 2 years.

         18. If female, "of childbearing potential", sexually active, and has not used any of the
             "acceptable contraceptive methods" for at least 2 months prior to trial entry:

               1. Of childbearing potential is defined as status post onset of menarche and not
                  meeting any of the following conditions: menopausal for at least 2 years, status
                  after bilateral tubal ligation for at least 1 year, status after bilateral
                  oophorectomy, or status after hysterectomy.

               2. Acceptable birth control methods are defined as 1 or more of the following:

             i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant,
             cervical ring).

             ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time
             during intercourse.

             iii. Intrauterine device (IUD). iv. Monogamous relationship with vasectomized partner.
             Partner must have been vasectomized for at least 6 months prior to the participant's
             trial entry.

         19. Female participants of childbearing potential and sexually active, who refuse to use
             an "acceptable contraceptive method" from Day 1 through 6 months after the last dose
             of investigational vaccine.

         20. Female participants who plan to donate ova from Day 1 through 6 months after the last
             dose of investigational vaccine.

         21. Female participants with any positive pregnancy test.

         22. Female participants who are pregnant or breastfeeding.