NCT03125473

Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Vaxart · Industry
• Sex: All
• Age: 19 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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).

Conditions

• Norovirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	VXA-G1.1-NN Oral Vaccine	The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high total doses.

Timeline

• Start date: 2017-04-07
• Primary completion: 2017-07-01
• Completion: 2018-05-06
• First posted: 2017-04-24
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study