Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

October 28, 2015

Primary Completion Date

November 27, 2018

Study Completion Date

November 27, 2018

Conditions
Gastroenteritis Norovirus
Interventions
BIOLOGICAL

Norovirus GII.2 Challenge

GII.2 Snow Mountain Norovirus Filtrate. Cohort 1: 1.2x10\^4 Genome Equivalent Copies (GEC) oral dose on Day 1. Cohort 2: either 1.2 x 10\^2 GEC or 1.2 x10\^6 GEC oral dose on Day 1, depending on the results of prior Cohort 1. Cohort 3: either 1GEC, 1.2 x 10\^1 GEC, 1.2 x 10\^2 GEC, 1.2 x 10\^3 GEC, 1.2 x 10\^5 GEC, or 1.2 x 10\^6 GEC, or 1.2 GEC x 10\^7 oral dose on Day 1, depending on the percentage of subjects with illness from Cohorts 1 and 2. Cohort 4: optimal dose of GEC as determined by the results of cohorts 1-3

OTHER

Placebo

Placebo: 80 ml of sterile water for oral administration

Trial Locations (1)

30030-1705

Emory Vaccine Center - The Hope Clinic, Decatur

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02473224 - Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies | Biotech Hunter | Biotech Hunter