Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population
Condition: Norovirus
Intervention: Norovirus GI.1/GII.4 Bivalent VLP Vaccine; 0.9% sodium chloride (saline); Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Intervention description: Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide, without MPL for IM injection; norovirus bivalent placebo-matching vaccine; Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with MPL and aluminum hydroxide for IM injection
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Norovirus

Summary:

      The purpose of this study is to further develop a formulation and dose regimen of the
      norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe
      in an elderly population aged 60 years and above.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is aged 18 to 49 years, or 60 years and older at the time of enrollment;

          2. Participants who are in good health, or in stable health status with no exclusionary
             medical or neuropsychiatric conditions at the time of entry into the trial as
             determined by medical history, physical examination (including vital signs) and
             clinical judgment of the Investigator;

          3. Participant signs and dates a written, Informed Consent Form (ICF) and any required
             privacy authorization prior to the initiation of any trial procedures, after the
             nature of the trial has been explained according to local regulatory requirements;

          4. Participants who can comply with trial procedures and are available for the duration
             of follow-up.

        Exclusion Criteria:

          1. Has a known hypersensitivity or allergy to any of the Norovirus (NoV) GI.1/GII.4
             Bivalent virus-like particle (VLP) Vaccine components;

          2. Has a clinically significant active infection (as assessed by the Investigator) or
             body temperature ≥38°C/100.4°F within 3 days of the intended date of vaccination;

          3. Participants with the presence of significant acute or chronic, uncontrolled medical
             or neuropsychiatric illness. Uncontrolled was defined as:

             Requiring institution of new medical or surgical treatment within 3 months prior to
             immunization, or Requiring a change in medication dosage in the 3 months prior to
             immunization due to uncontrolled symptoms or drug toxicity (elective dosage
             adjustments in stable participants were acceptable), or Hospitalization or an event
             fulfilling the definition of a serious adverse event within 3 months prior
             immunization.

          4. Has any unstable medical or neuropsychiatric condition, which in the Investigator's
             opinion poses a risk of unusual magnitude for the participant's age group of
             hospitalization, death, or an event meeting the definition of a serious adverse event
             within 2 months of immunization. The intent of this criterion is to recognize and
             allow for the frequent existence of significant health concerns in this population;
             but exclude those participants who are experiencing an acute decline in health status;

          5. Has any medical or neuropsychiatric condition, which in the Investigator's opinion,
             rendered the participant incompetent to provide informed consent or unable to provide
             valid safety observations and reports;

          6. 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;

          7. Participants with any history of progressive or severe neurologic disorder, history of
             seizure, or history of neuro-inflammatory disease (e.g. Guillain-Barre syndrome);

          8. Participants with 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;

          9. Has known or suspected autoimmune disease;

         10. Has known or suspected impairment/alteration of immune function, including:

             Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg
             body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled,
             intranasal, or topical corticosteroids is allowed).

             Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2
             mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1.

             Receipt of immunosuppressive therapy within 3 months prior to Day 1. Receipt of
             immunostimulants within 60 days prior to Day 1. 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.

             Human Immunodeficiency Virus (HIV) infection or HIV-related disease. Genetic
             immunodeficiency.

         11. Has abnormalities of splenic or thymic function;

         12. Has any significant disorder of coagulation or treatment with anticoagulant therapy
             that would increase the risk of intramuscular (IM) injection. Persons receiving
             prophylactic antiplatelet medication such as low dose of acetylsalicylic acid are
             eligible;

         13. Has any serious chronic or progressive disease according to judgment of the
             Investigator: cancer (malignancy other than resolved/excised skin lesion), insulin
             dependent Type I diabetes (Type II diabetes is accepted), cardiac, renal or hepatic
             disease;

         14. Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height
             in meters^2]);

         15. 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;

         16. Participants who received any other vaccines within 14 days (for inactivated vaccines)
             or 28 days (for live vaccines) prior to enrollment in this trial or who are planning
             to receive any vaccine within 28 days of investigational vaccine administration;

         17. Participants involved in trial conduct or their first degree relatives;

         18. Has history of substance or alcohol abuse within the past 2 years;

         19. Females who are pregnant or breastfeeding;

         20. If female of childbearing potential, sexually active with a male partner who has not
             been sterilized, and has not used any of the "acceptable contraceptive methods" for at
             least 2 months prior to trial entry:

             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.

             Acceptable birth control methods are defined as one 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 six months prior to the participants' trial entry.

         21. If female of childbearing potential and sexually active, refusal to use an "acceptable
             contraceptive method" from Day 1 and throughout the duration of the trial. In
             addition, they must be advised not to donate ova during this period;

         22. Females with any positive or indeterminate pregnancy test.