Phase 1 Norwalk Vaccine Study

PHASE1CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Norovirus
Interventions
DRUG

Adjuvant/Excipients

intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart

DEVICE

placebo

intranasal, puff of air, 2 doses, 21 days apart

BIOLOGICAL

Norwalk VLP Vaccine

intranasal, 50mcg, 2 doses--21 days apart

BIOLOGICAL

Norwalk VLP Vaccine

Intranasal, 100 mcg, 2 doses, 21 days apart

Trial Locations (4)

14642

University of Rochester Medical Center, Rochester

45229

Cincinnati Children's Hospital, Cincinnati

63104

Saint Louis University, St Louis

Unknown

University of Maryland Center for Vaccine Development, Baltimore

Sponsors
All Listed Sponsors
lead

LigoCyte Pharmaceuticals, Inc.

INDUSTRY