Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138476
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-08-26
Brief Title:
New Challenge Pool of Norwalk Virus Inoculum
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of a New Challenge Pool of Norwalk Virus Inoculum Lot 42399 in Human Subjects
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to see the number of volunteers that get sick from a Norwalk virus NV inoculation with typical symptoms of nausea vomiting and diarrhea If this NV preparation is shown to cause Norwalk illness then it can be used to test new vaccines in the future Additionally researchers hope to determine the lowest dose of NV inoculum that can be given to volunteers and cause illness Study participants will include 57 healthy adults ages 18-50 Participants will either be given the NV inoculum or placebo water without virus Participants will be hospitalized for a maximum of 7 days and a minimum of 4 days following the NV challenge Study procedures include physical exam blood testing and collection of saliva urine and stool samples Participants will be involved in study related procedures for up to 180 days
Detailed Description:
Noroviruses are the cause of most acute epidemic non-bacterial gastroenteritis 24-hour intestinal flu and Norwalk virus NV is the prototype strain of this group of viruses Although NV was identified some 30 years ago progress in understanding its molecular characteristics has been slow due to the inability to grow the virus in cell culture and the lack of an animal model As such most work must be performed in human volunteers The principal source of virus for research has been stool samples obtained from human volunteers who were experimentally infected with NV NIH-8fIIa obtained from the National Institutes for Health NIH The quantities of NV were sufficient to characterize the entire genome and significant advances have been made The original NV challenge pool obtained from the NIAIDNIH is no longer available Using stored stool specimens obtained from an otherwise healthy subject who was infected approximately 14 years ago with NV NIH-8fIIa a new pool filtrate was produced This study has been designed to support an IND application for NV challenge pool Lot 42399 to be submitted by the DMIDNIAIDNIH The safety and infectivity of the new NV challenge pool will be established by this protocol The clinical attack rate of Lot 42399 will be determined Initially 20 subjects will be challenged with a dose of NV Lot 42399 that approximates the dose used in previous challenge studies The predicted rate of infection in this study defined by fecal viral shedding or seroresponse is at least 90 of those who receive inoculation Approximately two-thirds of infected subjects are expected to become symptomatic Subsequently smaller groups of subjects will be challenged with lower dosages to determine the Human Infectious Dose 50 percent HID50 The overall objective of this study is to develop a challenge poolinoculum of NV The specific objectives of this clinical study are to determine the safety and acute toxicity of a new NV challenge pool to determine the NV clinical attack rate to determine the infection rate and HID50 of NV Lot 42399 to measure specific immunoglobulin responses to NV Lot 42399 inoculationinfection in blood saliva and intestinal excretions and examine peripheral blood mononuclear cells for the presence of NV Study participants will include 57 healthy adults ages 18-50 This double-blind study consists of informed consent a screening and enrollment period the NV challenge inpatient NV inoculation phase and a post challenge follow-up period Many subjects participating in this study are expected to become ill with typical symptoms and signs of viral gastroenteritis Subjects will be hospitalized for up to a maximum of 7 days and minimum of 4 days Participants will be involved in study related procedures for up to 180 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN272200800002C | None | None | None |
| BCM-IRB 10690 GCRC 2027 | None | None | None |