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J Infect Dis. 2010 Dec 1;202(11):1649-58. doi: 10.1086/657087. Epub 2010 Oct 27.

Adjuvanted intranasal Norwalk virus-like particle vaccine elicits antibodies and antibody-secreting cells that express homing receptors for mucosal and peripheral lymphoid tissues.

Author information

1
Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. selkamar@epi.umaryland.edu

Erratum in

  • J Infect Dis. 2011 Apr 1;203(7):1036.

Abstract

BACKGROUND:

Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide.

METHODS:

We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50- and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors.

RESULTS:

The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8- and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50- or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues.

CONCLUSIONS:

The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00806962.

Comment in

PMID:
20979455
PMCID:
PMC3722871
DOI:
10.1086/657087
[Indexed for MEDLINE]
Free PMC Article

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