US Patent No. 9,821,049

METHOD OF CONFERRING A PROTECTIVE IMMUNE RESPONSE TO NOROVIRUS


Patent No. 9,821,049
Issue Date November 21, 2017
Title Method Of Conferring A Protective Immune Response To Norovirus
Inventorship Charles Richardson, Bozeman, MT (US)
Thomas S. Vedvick, Federal Way, WA (US)
Thomas R. Foubert, Bozeman, MT (US)
Robert F. Bargatze, Bozeman, MT (US)
William Tino, Athens, GA (US)
Assignee Takeda Vaccines, Inc., Cambridge, MA (US)

Claim of US Patent No. 9,821,049

1. A method of eliciting protective immunity against Norovirus in a human comprising the steps of:
(i) intramuscularly administering to the human a vaccine comprising Norovirus virus-like particles (VLPs), wherein the Norovirus
VLPs are present in the vaccine in an amount of 1 ?g to 200 ?g, wherein the vaccine comprises at least one adjuvant that is
not a bacterially-derived exotoxin adjuvant, and wherein the administration of the vaccine elicits production of Norovirus-specific
functional antibodies in a blood sample from the human; and

(ii) measuring the Norovirus-specific functional antibodies in the blood sample from the human, wherein a geometric mean serum
titer of the Norovirus-specific functional antibodies greater than 40 as measured by a carbohydrate blocking assay is indicative
of protective immunity.