NCT02868073

Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

A Phase 1, Randomized, Double-Blind, Placebo-controlled, Dose-ranging Trial to Determine the Safety and Immunogenicity 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: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers

Detailed description

The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-G1.1-NN at a low dose, a high dose or placebo. Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-G1.1-NN prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group. Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.

Conditions

• Norovirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	VXA-G1.1-NN (high dose) Oral Vaccine Tablet	The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.
OTHER	VXA Placebo Tablets	The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
BIOLOGICAL	VXA-G1.1-NN (low dose) Oral Vaccine Tablet	The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.

Timeline

• Start date: 2016-07-29
• Primary completion: 2016-10-05
• Completion: 2017-10-01
• First posted: 2016-08-16
• Last updated: 2018-05-31

Locations

1 site across 1 country: United States