NCT00973284

Norwalk Vaccine Study

Phase 1-2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Safety and Efficacy Study in Healthy Adults of Intranasal Norwalk Virus-like Particle Vaccine in Experimental Human Norwalk Virus Infection

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.

Detailed description

The drug being tested in this study is called intranasal Norwalk virus-like particle (VLP) vaccine. Norwalk VLP vaccine is being tested to prevent viral acute gastroenteritis (AGE). This study will look at the illness rate of AGE in people who are administered the Norwalk VLP vaccine. The study enrolled 98 patients and was conducted in 2 stages: the Vaccination Stage and the Challenge Stage. In the Vaccination Stage participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Norwalk VLP Vaccine (100 µg VLP) intranasally * Placebo (dummy inactive powder) - this is a powder that looks like the study drug but has no active ingredient During the Challenge Stage participants were administered live Norwalk virus and were monitored for AGE. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 29 weeks Participants made multiple visits to the clinic and were contacted by telephone 6 months after last dose of study drug for a follow-up assessment.

Conditions

• Acute Gastroenteritis
• Norwalk Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Norwalk VLP vaccine	Norwalk VLP vaccine dry powder
BIOLOGICAL	mannitol and sucrose	Mannitol and sucrose as placebo-matching Norwalk VLP Vaccine dry powder
BIOLOGICAL	Norwalk virus	Norwalk virus solution

Timeline

• Start date: 2009-08-04
• Primary completion: 2010-04-07
• Completion: 2010-08-18
• First posted: 2009-09-09
• Last updated: 2017-08-08

Locations

3 sites across 1 country: United States