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Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies

NCT02473224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-12-07

No results posted yet for this study

Summary

This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype 2 (GII.2) isolate designated Snow Mountain virus (SMV). The study duration is 24 - 36 months. The primary objectives are to: 1) evaluate the safety and reactogenicity of the GII.2 Snow Mountain norovirus challenge stock and 2) determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve illness in a high proportion (= / \> 75%) of subjects.

Conditions

  • Gastroenteritis Norovirus

Interventions

BIOLOGICAL

Norovirus GII.2 Challenge

GII.2 Snow Mountain Norovirus Filtrate. Cohort 1: 1.2x10\^4 Genome Equivalent Copies (GEC) oral dose on Day 1. Cohort 2: either 1.2 x 10\^2 GEC or 1.2 x10\^6 GEC oral dose on Day 1, depending on the results of prior Cohort 1. Cohort 3: either 1GEC, 1.2 x 10\^1 GEC, 1.2 x 10\^2 GEC, 1.2 x 10\^3 GEC, 1.2 x 10\^5 GEC, or 1.2 x 10\^6 GEC, or 1.2 GEC x 10\^7 oral dose on Day 1, depending on the percentage of subjects with illness from Cohorts 1 and 2. Cohort 4: optimal dose of GEC as determined by the results of cohorts 1-3

OTHER

Placebo

Placebo: 80 ml of sterile water for oral administration

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-28
Primary Completion
2018-11-27
Completion
2018-11-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02473224 on ClinicalTrials.gov