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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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Snow Mountain stool filtrate, Placebo
Emory Vaccine Center - The Hope Clinic
Not yet recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2015-06-17T03:38:22-0400
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Mass of snow and/or ice falling down a mountain or incline.
A genus in the family CALICIVIRIDAE, associated with epidemic GASTROENTERITIS in humans. The type species, NORWALK VIRUS, contains multiple strains.
The type species in the genus NOROVIRUS, first isolated in 1968 from the stools of school children in Norwalk, Ohio, who were suffering from GASTROENTERITIS. The virions are non-enveloped spherical particles containing a single protein. Multiple strains are named after the places where outbreaks have occurred.
A snow sport which uses skis to glide over the snow. It does not include water-skiing.
A condition of chronic gastroenteritis in adult pigs and fatal gastroenteritis in piglets caused by a CORONAVIRUS.
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