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.
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Rate of Solicited Adverse Events
Timeframe: Day 1 (Vaccination) to 7 days post vaccination
Rate of Unsolicited Adverse Events
Timeframe: Day 1 (Vaccination) to 28 days post vaccination
Immunogenicity - VP1 Specific IgA ASC
Timeframe: Day 1 (vaccination) to 7 days post-vaccination
Immunogenicity - BT50 Assay
Timeframe: Day 1 (vaccination) to 28 days post-vaccination