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

NCT ID: NCT03721549

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-03
• Study Completion Date: 2018-11-28

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.

Conditions

Norovirus Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Moderate Dose Inoculum

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

Group Type: EXPERIMENTAL

Norwalk GI.1 Virus

Intervention Type: BIOLOGICAL

Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.

Higher Dose Inoculum

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

Group Type: EXPERIMENTAL

Norwalk GI.1 Virus

Intervention Type: BIOLOGICAL

Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.

Interventions

Norwalk GI.1 Virus

Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vaxart

INDUSTRY

Sponsor Role: collaborator

WCCT Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

WCCT Global

Costa Mesa, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VXA-G11-201.1

Identifier Type: -

Identifier Source: org_study_id