A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers
Condition: Norovirus Infections
MeSH terms: Caliciviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose
      of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The
      active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up
      continues by phone screen at Day 180 and Day 365.
    

Detailed description: 
      Primary Objective

        -  To determine the immunogenicity of the VXA-G1.1-NN oral vaccine administered via
           multiple sub-doses over a 4-hour period to deliver a total dose of

           1E11 IU ±0.5 log Secondary Objectives

        -  To determine the safety and tolerability of the VXA-G1.1-NN oral vaccine administered
           via multiple sub-doses over a 4-hour period to deliver a total dose of 1E11 IU ±0.5 log

      This is an open-label study in healthy adult participants aged 18-55 years old. The study
      will enroll 8 subjects to a single treatment cohort, all of whom will receive a single 1E11
      IU± 0.5 log at Day 1. This dose will be administered in a step wise manner over 4 hours with
      1/3 of the dose administered at T=0, 1/3 of the dose administered at T= 2 hours and 1/3 of
      the dose administered at T=4 hours.

      The study will include a Screening Period, Active Period (Day 1 to Day 29, 4 weeks post
      vaccination) and a Safety Follow-up Period through 12 months post vaccination (Day 365). In
      addition, participants will be contacted by phone during the Safety Follow-up Period to
      assess for Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) and New Onset of
      Chronic Illness (NOCIs).

      After signing an informed consent, participants will undergo screening assessments to
      determine study eligibility within a 30-day screening period. Eligible participants will be
      enrolled and receive their first dose of study vaccine on Day 1.

      During the Active Period, participants will record any potential solicited symptoms of
      reactogenicity daily for 1 week post study vaccination. Participants will return to the site
      as specified in the Schedule of Activities to have safety assessments and samples collected
      for evaluation of immunogenicity. Approximately 8 subjects will be vaccinated in the active
      phase.

      The following study visits and remote contacts will be conducted during the study:

      Active Period:

        -  Screening Period (Days -30 to -1)

        -  Day 1 Visit (Baseline assessments, vaccination, sample collection)

        -  Day 8 Visit (Safety assessments, sample collection)

        -  Day 29 End of Active Period; (Safety assessments, sample collection)

      Safety Follow-Up Period:

        -  Day 180 (follow-up phone call for safety)

        -  Day 365 (follow-up phone call for safety): Study completion
    

Intervention name(s): VXA-G1.1-NN
Intervention type(s): Biological
Intervention description(s): Norovirus GI.1 Norwalk VP1 Vaccine (VXA-G1.1-NN) E1/E3-Deleted Replication-Defective Recombinant Adenovirus 5 with Adjuvant Oral Tablet Vaccine.
Other intervention name(s): Oral Tableted Ad5 Norovirus GI.1 Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention