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Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model

Primary Purpose

Norovirus Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Norwalk GI.1 Virus
Sponsored by
WCCT Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Norovirus Infection

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • General good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the research monitor and sponsor
  • Available for all planned visits and to spend at least 5 days in confinement
  • Confirmed blood type (A or O)
  • Demonstrated to be H type-1 antigen secretor positive (by saliva test)
  • Body mass index between 17 and 30 at screening
  • Female subjects must have a negative pregnancy test and either use contraceptives or be sterile
  • Available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly

Exclusion Criteria:

  • Presence of significant medical condition
  • Donation or use of blood or blood products within 4 weeks prior to challenge
  • Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
  • Abnormal stool pattern
  • Any gastroenteritis within the past 2 weeks
  • Occupational hazards, including having daily contact with children under the age of 5, women known to be pregnant, employment in the food service industry, health care workers, etc.

Sites / Locations

  • WCCT Global

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Moderate Dose Inoculum

Higher Dose Inoculum

Arm Description

Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies

Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies

Outcomes

Primary Outcome Measures

Frequency of Norovirus Gastroenteritis (NVG)
Occurrence of NVG within 7 days post-challenge

Secondary Outcome Measures

Frequency of Serious Adverse Events (SAEs)
Occurrence of SAEs

Full Information

First Posted
October 24, 2018
Last Updated
January 9, 2020
Sponsor
WCCT Global
Collaborators
Vaxart
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1. Study Identification

Unique Protocol Identification Number
NCT03721549
Brief Title
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Official Title
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WCCT Global
Collaborators
Vaxart

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Norovirus Infection

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Dose Inoculum
Arm Type
Experimental
Arm Description
Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies
Arm Title
Higher Dose Inoculum
Arm Type
Experimental
Arm Description
Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies
Intervention Type
Biological
Intervention Name(s)
Norwalk GI.1 Virus
Intervention Description
Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
Primary Outcome Measure Information:
Title
Frequency of Norovirus Gastroenteritis (NVG)
Description
Occurrence of NVG within 7 days post-challenge
Time Frame
7 days post-challenge
Secondary Outcome Measure Information:
Title
Frequency of Serious Adverse Events (SAEs)
Description
Occurrence of SAEs
Time Frame
42 ± 3 days post-challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: General good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the research monitor and sponsor Available for all planned visits and to spend at least 5 days in confinement Confirmed blood type (A or O) Demonstrated to be H type-1 antigen secretor positive (by saliva test) Body mass index between 17 and 30 at screening Female subjects must have a negative pregnancy test and either use contraceptives or be sterile Available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly Exclusion Criteria: Presence of significant medical condition Donation or use of blood or blood products within 4 weeks prior to challenge Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic Abnormal stool pattern Any gastroenteritis within the past 2 weeks Occupational hazards, including having daily contact with children under the age of 5, women known to be pregnant, employment in the food service industry, health care workers, etc.
Facility Information:
Facility Name
WCCT Global
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model

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