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Phase I Study to Determine the Optimal Human Challenge Dose for a Norovirus GII.4 Challenge Stock (CIN-1)

NCT02337842 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-06-03

No results posted yet for this study

Summary

This is phase I, double blind, placebo-controlled safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to healthy adults 18-49 years of age. Subjects susceptible to the human norovirus GII.4 challenge strain. The challenge study will be conducted in 2-3 cohorts of approximately 20 subjects each.Subjects will remain in the inpatient facility for at least four days following challenge and assessed daily for clinical and virologic evidence of norovirus infection. The primary objectives are to evaluate the safety and reactogenicity of the norovirus GII.4 (CIN-1; 031693) challenge stock and to determine a safe and optimal challenge dose of Norovirus GII.4 Challenge Stock norovirus to achieve illness in \> /=50% of subjects. Illness is defined as: diarrhea (\>3 loose or liquid stools or \>300 gm of loose or liquid stool /24h), and/or vomiting during the inpatient period, in a participant with evidence of infection.

Conditions

  • Gastroenteritis Norovirus

Interventions

BIOLOGICAL

Norovirus GII.4 Challenge Pool CIN-1

Norovirus Challenge GII.4 Strain 031693. Cohort 1: receive single oral dose of GII.4 CIN-1 at 10\^3 RT-PCR units. Cohort 2: single oral dose of GII.4 CIN-1 either at 10\^2 or 5x10\^3 RT-PCR units. Cohort 3: single oral dose of GII.4 CIN-1 at either 10\^4, 10\^3, 5x10\^2 or 5x10\^1 RT-PCR units. Cohort 4: single oral dose of GII.4 CIN-1 at either 5x10\^4 or 5x10\^3 or 10\^3 or 10\^2 or 10\^4 or 5x10\^2 or 5x10\^1RT-PCR units.

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
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT02337842 on ClinicalTrials.gov