48
Participants
Start Date
March 28, 2022
Primary Completion Date
July 13, 2023
Study Completion Date
January 8, 2024
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.
Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
NIH