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

Sep-14

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:
<p>{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</p>

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