Norovirus Gastroenteritis Clinical Trial
Official title:
A Phase 1b, Open-Label, Dose-Optimization Trial of an Adenoviral-vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers
A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally to healthy volunteers
This study will enroll approximately 60 subjects in four cohorts of 15 subjects each. The
cohorts may be enrolled and run in parallel or overlap; they do not have to run sequentially.
The dosing for each cohort will be as follows:
Cohort 1: Multiple low dose on Days 1 and 8 Cohort 2: Multiple low dose on Days 1, 3 and 5
Cohort 3: Multiple low dose on Days 1 and 29 Cohort 4: Multiple high dose on Days 1 and 29
All subjects receiving study drug will have safety and immunogenicity assessments completed
through Study Day 57 following their initial vaccination. Subjects may also be evaluated for
persistent immunogenicity at Day 180 and will be followed for safety for 12 months following
initial vaccination (Study Day 365).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02868073 -
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
|
Phase 1 |