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

NCT03721549 | Completed Phase 1 Results FDA Drug

• 1 other identifier: VXA-G11-201.1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Frequency of Norovirus Gastroenteritis (NVG)

  Occurrence of NVG within 7 days post-challenge

  7 days post-challenge

Secondary Outcomes (1)

• Frequency of Serious Adverse Events (SAEs)

  42 ± 3 days post-challenge

Study Arms (2)

Moderate Dose Inoculum

EXPERIMENTAL

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

Biological: Norwalk GI.1 Virus

Higher Dose Inoculum

EXPERIMENTAL

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

Biological: Norwalk GI.1 Virus

Interventions

Norwalk GI.1 Virus BIOLOGICAL

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

Higher Dose Inoculum; Moderate Dose Inoculum

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• WCCT Global: lead
• Vaxart: collaborator

Study Sites (1)

WCCT Global

Costa Mesa, California, 92626, United States

Location

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Erin Flynn, Associate Director of Regulatory Affairs
• Organization: WCCT Global

erin.flynn@wcct.com

7207713080

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 26, 2018
• Study Start: October 3, 2018
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: January 22, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Locations

US (1)