Norovirus vaccine against experimental human GII.4 virus illness: a challenge study in healthy adults.

ABSTRACT:

Background

Vaccines against norovirus, the leading cause of acute gastroenteritis, should protect against medically significant illness and reduce transmission.

Methods

In this randomized, double-blind, placebo-controlled trial, 18- to 50-year-olds received 2 injections of placebo or norovirus GI.1/GII.4 bivalent vaccine-like particle (VLP) vaccine with 3-O-desacyl-4'-monophosphoryl lipid A (MPL) and alum. Participants were challenged as inpatients with GII.4 virus (4400 reverse transcription polymerase chain reaction [RT-PCR] units), and monitored for illness and infection.

Results

Per protocol, 27 of 50 (54.0%) vaccinees and 30 of 48 (62.5%) controls were infected. Using predefined illness and infection definitions, vaccination did not meet the primary endpoint, but

SUBMITTER: Bernstein DI 

PROVIDER: S-EPMC5914500 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature