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Virus Therapy

Norovirus GII.4 Challenge Pool for Norovirus

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 180

Awards & highlights

Study Summary

This trial is testing a potential vaccine for Norovirus, specifically Norovirus GII.4. They will be testing different doses on different groups of people to find the optimal dose to achieve illness in at least 50% of subjects.

Eligible Conditions

Norovirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of norovirus-associated illness (vomiting, diarrhea, positive PCR) in secretor-positive subjects

Secondary outcome measures

Duration (hours) of vomiting and/or diarrhea

Duration (number of days) of viral secretion as measured by qRT-PCR

Modified Vesikari score

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

Single dose (3.5x10^5 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) will be given orally to subjects with functional FUT-2 gene (secretor positive), n=15, and single dose (3.5x10^5 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) will be given to subjects with a lack a non-functional FUT-2 gene (non-secretor), n=1, on Day 1

Group II: Cohort 2Experimental Treatment1 Intervention

Single dose (3.5x10^4 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) will be given orally to subjects with functional FUT-2 gene (secretor positive), n=15, and single dose (3.5x10^4 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) will be given to subjects with a lack a non-functional FUT-2 gene (non-secretor), n=1, on Day 1

Group III: Cohort 1Experimental Treatment1 Intervention

Single dose (3.5x10^3 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) will be given orally to subjects with functional FUT-2 gene (secretor positive), n=15, and single dose (3.5x10^3 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) will be given to subjects with a lack a non-functional FUT-2 gene (non-secretor), n=1, on Day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Norovirus GII.4 Challenge Pool

2022

Completed Phase 1

~50

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,481,084 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the target recruitment size for this trial?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial is in the process of recruiting candidates, with an initial posting date on January 14th 2022 and an update as recent as November 23rd 2022. The study necessitates 48 patients from a single centre."

Answered by AI

What are the selection criteria for individuals to take part in this clinical experiment?

"This clinical trial is recruiting 48 individuals with gastroenteritis aged between 18 and 49. In order to be eligible, applicants must meet a range of criteria including providing informed consent, being male or non-pregnant females in the specified age bracket, having negative pregnancy test for women of childbearing potential, exhibiting good general health as determined by medical history/examination and demonstrating comprehension of the study protocol via scoring 70% or above on an associated quiz. Additionally, participants must commit to attend all visits which include at least 96 hours spent as an inpatient."

Answered by AI

Are individuals above the age of 65 eligible for this investigation?

"This trial is currently accepting participants aged 18-49."

Answered by AI

Has the FDA sanctioned Norovirus GII.4 Challenge Pool?

"Due to the limited clinical data surrounding Norovirus GII.4 Challenge Pool, we have assigned it a safety rating of 1 on our scale from 1-3. This is reflective of its status as a Phase 1 trial without much evidence regarding effectiveness or security."

Answered by AI

Is this research study open for new participants?

"Affirmative. The information hosted on clinicaltrials.gov validates that this medical research, which was first published on January 14th 2022, has open positions for applicants. 48 individuals must be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Norovirus Challenge Model

2022. "Phase I Norovirus Challenge Model". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04174560.