NCT02473224

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

Completed Phase 1 Last updated 7 December 2018

What this trial tests

Phase 1 trial testing Norovirus GII.2 Challenge in Gastroenteritis Norovirus in 44 participants. Completed in 27 November 2018.

Timeline

28 October 2015

Primary endpoint
27 November 2018

27 November 2018

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	other
Enrollment	44
Start date	28 October 2015
Primary completion	27 November 2018
Estimated completion	27 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Norovirus GII.2 Challenge — full drug profile →
• Placebo

Conditions studied

• Gastroenteritis Norovirus — all drugs for Gastroenteritis Norovirus →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 49, any sex, with Gastroenteritis Norovirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype 2 (GII.2) isolate designated Snow Mountain virus (SMV). The study duration is 24 - 36 months. The primary objectives are to: 1) evaluate the safety and reactogenicity of the GII.2 Snow Mountain norovirus challenge stock and 2) determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve illness in a high proportion (= / \> 75%) of subjects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dose-Response of a Norovirus GII.2 Controlled Human Challenge Model Inoculum.
   Rouphael N, Beck A, Kirby AE, Liu P, et al · · 2022 · cited 10× · PMID 35137154 · DOI 10.1093/infdis/jiac045
2. Blockade Antibody Responses in Human Subjects Challenged with a New Snow Mountain Virus Inoculum.
   Ibaraki M, Lai L, Huerta C, Natrajan MS, et al · · 2023 · cited 1× · PMID 38707746 · DOI 10.26502/ami.936500129