Norovirus Vaccine Against Experimental Human GII.4 Virus Illness: A Challenge Study in Healthy Adults

Publication Type
Journal Article
Year of Publication
Bernstein, D; Atmar, RL; Lyon, GM; Treanor, J; Chen, WH; Jiang, X; Vinje, J; Gregoricus, N; Frenck Jr, RW; Moe, CL; Al-Ibrahim, MS; Barrett, J; Ferreira, J; Estes, MK; Graham, DY; Goodwin, R; Borkowski, A; Clemens, R; Mendelman, PM
J Infect Dis
jiu497 [pi
Date Published
acute gastroenteritis; challenge; norovirus; vaccine
{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