Norovirus Bivalent-Vaccine Efficacy Study

Summary

The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.

Timeline

Start

2012-07-16

Primary completion

2014-03-01

Completion

2014-03-18

Outcome

Missed primary endpoint

paper vaccination did not meet the primary endpoint PMID 25210140 ↗

registry Norovirus Bivalent VLP Vaccine vs Placebo; p = 0.674; Fisher Exact; note: No multiplicity adjustment. NCT01609257 ↗

Publications

• Results Bernstein DI, Atmar RL, Lyon GM, Treanor JJ, Chen WH, Jiang X, Vinje J, Gregoricus N, Frenck RW Jr, Moe CL, Al-Ibrahim MS, Barrett J, Ferreira J, Estes MK, Graham DY, Goodwin R, Borkowski A, Clemens R, Mendelman PM. Norovirus vaccine against experimental human GII.4 virus illness: a challenge study in healthy adults. J Infect Dis. 2015 Mar 15;211(6):870-8. doi: 10.1093/infdis/jiu497. Epub 2014 Sep 9.
• Atmar RL, Bernstein DI, Lyon GM, Treanor JJ, Al-Ibrahim MS, Graham DY, Vinje J, Jiang X, Gregoricus N, Frenck RW, Moe CL, Chen WH, Ferreira J, Barrett J, Opekun AR, Estes MK, Borkowski A, Baehner F, Goodwin R, Edmonds A, Mendelman PM. Serological Correlates of Protection against a GII.4 Norovirus. Clin Vaccine Immunol. 2015 Aug;22(8):923-9. doi: 10.1128/CVI.00196-15. Epub 2015 Jun 3.
• Sundararajan A, Sangster MY, Frey S, Atmar RL, Chen WH, Ferreira J, Bargatze R, Mendelman PM, Treanor JJ, Topham DJ. Robust mucosal-homing antibody-secreting B cell responses induced by intramuscular administration of adjuvanted bivalent human norovirus-like particle vaccine. Vaccine. 2015 Jan 15;33(4):568-76. doi: 10.1016/j.vaccine.2014.09.073. Epub 2014 Nov 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Norovirus Bivalent Vaccine	Vaccine	5 ug	Intramuscular
Subject	Norovirus Bivalent Vaccine	Vaccine	15 ug	Intramuscular
Subject	Norovirus Bivalent Vaccine	Vaccine	50 ug	Intramuscular
Subject	Norovirus Bivalent Vaccine	Vaccine	150 ug	Intramuscular

Indications

No indication recorded.