Norovirus Vaccine Against Experimental Human GII.4 Virus Illness: A Challenge Study in Healthy Adults
09/2014
Journal Article
Authors:
Bernstein, D.;
Atmar, R.L.;
Lyon, G.M.;
Treanor, J.;
Chen, W.H.;
Jiang, X.;
Vinje, J.;
Gregoricus, N.;
Jr, R.W.Frenck;
Moe, C.L.;
Al-Ibrahim, M.S.;
Barrett, J.;
Ferreira, J.;
Estes, M.K.;
Graham, D.Y.;
Goodwin, R.;
Borkowski, A.;
Clemens, R.;
Mendelman, P.M.
Secondary:
J Infect Dis
Volume:
jiu497 [pi
URL:
http://www.ncbi.nlm.nih.gov/pubmed/25210140
Keywords:
acute gastroenteritis; challenge; norovirus; vaccine
Abstract:
{BACKGROUND: Vaccines against norovirus, the leading cause of acute gastroenteritis, should protect against medically significant illness and reduce transmission. METHODS: In this randomised, double-blind, placebo-controlled trial, 18-50 year-olds received two injections of placebo or norovirus GI.1/GII.4 bivalent VLP vaccine with MPL and alum. Participants were challenged as inpatients with GII.4 virus (4400 RT-PCR units), and monitored for illness and infection. RESULTS: Per-protocol, 27/50 (54.0%) vaccinees and 30/48 (62.5%) controls were infected. Using predefined illness and infection definitions, vaccination did not meet the primary endpoint, but self-reported cases of severe (0 vaccinees vs 8.3% controls
