Phase I Norovirus Challenge Model

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 28, 2022

Primary Completion Date

July 13, 2023

Study Completion Date

January 8, 2024

Conditions
Gastroenteritis Norovirus
Interventions
BIOLOGICAL

Norovirus GII.4 Challenge Pool

Subjects will be NPO (nothing by mouth) for at least 90 minutes followed by ingestion of 60 mL of a 2% sodium bicarbonate solution by mouth. 2 minutes later, subjects will be administered Norovirus GII.4 CIN-3. Five minutes following administration of the challenge dose, subjects will be administered a 60 mL volume of a 2% sodium bicarbonate solution and then remain NPO for at least the next 90 minutes. Subjects will be observed during the 60 minutes after receipt of the challenge by a study team member to detect and treat any immediate adverse reactions.

Trial Locations (1)

45229-3039

Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH