Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines
Condition: Norovirus Infection
MeSH terms: Caliciviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety
      and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1
      or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study
      consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized
      to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be
      followed for ~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of
      an open label booster vaccination for the bivalent treatment group ~4 months post initial
      vaccination. All subjects will be followed for long term safety for 1 year post initial
      vaccination.
    

Detailed description: 
      VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety
      and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1
      or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study
      consists of 2 parts with will enroll 86 subjects:

      Part 1 - Double Blind Period: Post confirmation of eligibility subjects will be randomized in
      a double-blinded manner to one of four treatment arms. Treatment Group 1 will contain an
      open-label sentinel group of 6 subjects to be enrolled prior to initiation of subsequent
      treatment groups. After review of the safety data and confirmation the dose is well tolerated
      through Study Day 8, the rest of the study will proceed in a double-blinded, randomized
      fashion. The 6 sentinel subjects will not be part of the 16 subjects in Treatment Group 1 to
      be enrolled in the double-blinded placebo-controlled cohort; randomization will be 1:1:2:1
      for Treatment Groups 1 through 4 respectively.

      Study Design and Vaccine Groups

        1. Monovalent GII.4 VXA-G2.4-NS (6 sentinels / 16 randomized)

        2. Monovalent GI.1 VXA-G1.1-NN (16 randomized)

        3. Bivalent GII.4/GI.1 VXA-G2.4-NS + VXA-G1.1-NN (32 randomized)

        4. Placebo Tablets no vaccine (16 randomized)

      Subjects will be followed for ~4 weeks post vaccination for safety and immunogenicity. The
      study database will be locked post completion of Day 29 visits.

      Part 2 will consist of an open label booster vaccination for the bivalent treatment group ~4
      months post initial vaccination. Subjects will be followed for safety and immunogenicity for
      ~4 weeks post the boost.

      All subjects will be followed for long term safety for 1 year post initial vaccination.
    

Intervention name(s): VXA-G1.1-NN; VXA-G2.4-NS; Placebo Tablets
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Monovalent GI.1 tableted vaccine; Monovalent GII.4 tableted vaccine; Tablets matching in number and appearance to active vaccine doses
Other intervention name(s): GI.1 oral vaccine tablet; GII.4 oral vaccine tablet; Oral tablets for control arm
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label sentinel followed by Randomized, double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention