CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Norwalk GI.1 Virusbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03721549
NCT03721549Phase 1Completed
CompareCT.gov

Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model

WCCT Global·interventional·Posted Oct 26, 2018·Updated Jan 22, 2020

In Brief

A Phase 1 clinical trial evaluating Norwalk GI.1 Virus for Norovirus Infection. Completed, enrolled 16 participants across 1 site.

Detailed Summary

There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNorovirus Infection
CountriesUnited States
CollaboratorsVaxart

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedOct 26, 2018
Enrollment StartOct 3, 2018
Primary CompletionNov 28, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.7 years ago

Interventions

Norwalk GI.1 Virusbiological

Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.