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

2015-06-17 03:38:22 | BioPortfolio

Summary

This is a phase I, randomized, double blind, 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 primary objectives are to evaluate the safety and reactogenicity of the norovirus GII.2 challenge stock and to determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve illness in a high proportion of subjects. The secondary objective is to determine the rate of infection in study participants after norovirus GII.2 challenge.

Description

This is a phase I, randomized, double blind, 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), administered to healthy adults 18-49 years of age. Groups of 11 subjects each will be admitted to the inpatient hospital research unit, challenged with live SMV by oral administration, and remain in isolation in the unit for at least 4 days following challenge. The study duration is 18-24 months. Subjects will be followed post-challenge for safety, reactogenicity, and illness (primary objectives), and secondary or exploratory objectives including infection and immune responses. There will be multiple clinical assessments and collection of blood, emesis, saliva, and stool specimens. The primary objectives are to evaluate the safety and reactogenicity of the norovirus GII.2 challenge stock and to determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve illness in a high proportion of subjects. The secondary objective is to determine the rate of infection in study participants after norovirus GII.2 challenge.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Conditions

Gastroenteritis Norovirus

Intervention

Snow Mountain stool filtrate, Placebo

Location

Emory Vaccine Center - The Hope Clinic
Decatur
Georgia
United States
30030-1705

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-17T03:38:22-0400

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