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

Norovirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721549
• Other study ID #: VXA-G11-201.1
• Status: Completed
• Phase: Phase 1
• Start date: October 3, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: January 2020
• Source: WCCT Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Norovirus Infection

Intervention

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.

Locations

Country	Name	City	State
United States	WCCT Global	Costa Mesa	California

Sponsors (2)

Lead Sponsor	Collaborator
WCCT Global	Vaxart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Norovirus Gastroenteritis (NVG)	Occurrence of NVG within 7 days post-challenge	7 days post-challenge
Secondary	Frequency of Serious Adverse Events (SAEs)	Occurrence of SAEs	42 ± 3 days post-challenge