Advertisement

Topics

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

2015-02-24 23:08:22 | BioPortfolio

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.

Description

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. The unblinded pharmacist will assign treatments. Subjects will be admitted to an inpatient nursing unit, challenged with live GII.4 Norovirus strain by oral administration, remain in the unit for at least 4 days following challenge and then followed for post-challenge safety and efficacy with multiple clinical assessments and collection of blood and stool specimens.

Subjects susceptible to the human norovirus GII.4 challenge strain, CIN-1 (i.e. presence of a functional FUT-2 gene), regardless of ABO blood type, will be housed in the Cincinnati Center for Clinical Research (CCCR) inpatient facility and challenged orally with different doses of the virus. The challenge study will be conducted in 2-3 cohorts of approximately 20 subjects each, with the initial cohort receiving 103 RT-PCR units or placebo (9 "challenge" and 1 "placebo" per 10 subjects). Based on the illness rate of acute gastroenteritis (AGE) in the initial cohort, the second cohort will be enrolled to receive a challenge dose based on the results of the previous studies. Additional cohorts may be necessary. Illness is defined as infection accompanied by vomiting and/or diarrhea during the inpatient stay.Two to three additional subjects per cohort will serve as alternates in the event that any of the study subjects are unavailable or become ineligible at the time of the inpatient study.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. Subjects will return to the investigational site for evaluation on Day 6 (+2 days) and about 15 (14-16 days) and 30 days (28-35 days) and 45 (40-45 days) post challenge.

Study Design

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

Conditions

Gastroenteritis Norovirus

Intervention

Placebo, Norovirus GII.4 Challenge Pool CIN-1

Location

Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati
Ohio
United States
45229-3026

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-02-24T23:08:22-0500

Clinical Trials [374 Associated Clinical Trials listed on BioPortfolio]

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

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 (...

Efficacy and Safety of Nitazoxanide for the Treatment of Norovirus

This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant re...

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population

The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an eld...

Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults

The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 Bivalent Virus-Like Particle Vaccine against moderate or severe acute gastroenteritis (AGE) due to g...

Identification of Host Factors of Norovirus Infections in Mini-Gut Model

The primary objective in this study is to establish a list of host cellular proteins that mediate norovirus infection. Norovirus is one of the most common pathogens attributed to diarrhea...

PubMed Articles [4835 Associated PubMed Articles listed on BioPortfolio]

Estimating the burden of medically-attended norovirus gastroenteritis: modelling linked primary care and hospitalization datasets.

Norovirus is the leading cause of community-acquired and nosocomial acute gastroenteritis. Routine testing for norovirus is seldom undertaken and diagnosis is mainly based on presenting symptoms. This...

Emergence of multiple norovirus strains in Thailand, 2015-2017.

Norovirus is a major cause of non-bacterial acute gastroenteritis worldwide. Infection can be sporadic or result in widespread outbreaks. The surveillance of norovirus samples (n = 1591) obtained ...

GII.4 Norovirus Recombinant Causes Gastroenteritis Epidemic in Eastern Australia, Winter 2017.

In Victoria, Australia, 160 gastroenteritis outbreaks were norovirus positive for the period January - September 2017. A distinctive peak in norovirus outbreaks was seen May - August, with 118 positiv...

Genotypic and Epidemiological Trends of Acute Gastroenteritis Associated with Noroviruses in China from 2006 to 2016.

There are periodical norovirus-associated acute gastroenteritis outbreaks around the world. This study aimed to analyze the molecular and epidemiological features of norovirus infections in China duri...

Ondansetron treatment reduces rotavirus symptoms-A randomized double-blinded placebo-controlled trial.

Rotavirus and norovirus cause acute gastroenteritis with severe diarrhoea and vomiting, symptoms that may lead to severe dehydration and death. The objective of this randomized double-blinded placebo-...

Medical and Biotech [MESH] Definitions

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 condition of chronic gastroenteritis in adult pigs and fatal gastroenteritis in piglets caused by a CORONAVIRUS.

Disorder characterized by a decrease or lack of platelet dense bodies in which the releasable pool of adenine nucleotides and 5HT are normally stored.

INFLAMMATION of any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM. Causes of gastroenteritis are many including genetic, infection, HYPERSENSITIVITY, drug effects, and CANCER.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial