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

January 9, 2020 updated by: WCCT Global
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • WCCT Global

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate Dose Inoculum
Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies
Biological: Norwalk GI.1 Virus
Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
Experimental: Higher Dose Inoculum
Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies
Biological: Norwalk GI.1 Virus
Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Norovirus Gastroenteritis (NVG)
Time Frame: 7 days post-challenge
Occurrence of NVG within 7 days post-challenge
7 days post-challenge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Serious Adverse Events (SAEs)
Time Frame: 42 ± 3 days post-challenge
Occurrence of SAEs
42 ± 3 days post-challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WCCT Global

Collaborators

Vaxart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

November 28, 2018

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VXA-G11-201.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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