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


Journal Article

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.

J Infect Dis

jiu497 [pi


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

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