US 12,076,397 B2
Emulsion adjuvant for intramuscular, intradermal and subcutaneous administration
James R. Baker, Jr., Ann Arbor, MI (US); Douglas M. Smith, Ann Arbor, MI (US); and Susan Ciotti, Ann Arbor, MI (US)
Assigned to THE REGENTS OF THE UNIVERSITY OF MICHIGAN, Ann Arbor, MI (US); and BLUEWILLOW BIOLOGICS, INC., Ann Arbor, MI (US)
Appl. No. 16/300,423
Filed by The Regents of the University of Michigan, Ann Arbor, MI (US); and NanoBio Corporation, Ann Arbor, MI (US)
PCT Filed May 10, 2017, PCT No. PCT/US2017/031958
§ 371(c)(1), (2) Date Nov. 9, 2018,
PCT Pub. No. WO2017/196979, PCT Pub. Date Nov. 16, 2017.
Claims priority of provisional application 62/334,267, filed on May 10, 2016.
Prior Publication US 2020/0405846 A1, Dec. 31, 2020
Int. Cl. A61K 39/395 (2006.01); A61K 9/00 (2006.01); A61K 9/107 (2006.01); A61K 38/38 (2006.01); A61K 39/12 (2006.01); A61K 39/145 (2006.01); A61K 39/39 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61K 39/00 (2006.01)
CPC A61K 39/39 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0043 (2013.01); A61K 9/107 (2013.01); A61K 38/38 (2013.01); A61K 39/12 (2013.01); A61K 39/145 (2013.01); A61K 47/10 (2013.01); A61K 47/186 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); A61K 2039/54 (2013.01); A61K 2039/55566 (2013.01)] 6 Claims
 
1. An immunogenic composition formulated for administration via injection comprising:
an oil in water emulsion comprising dioctadecyldimethylammonium chloride (DODAC), a non-ionic surfactant, an organic solvent, oil, and water, wherein the surfactant blend ratio of DODAC to non-ionic surfactant is 1:6, and
an antigen;
wherein the antigen is an inactivated microbial pathogen, an isolated protein from a microbial pathogen, and/or a recombinant protein from a microbial pathogen; and
wherein the immunogenic composition produces a cell mediated immune response comprising elevated levels of IFN-γ and detectable, antigen-specific neutralizing antibody titers when administered via injection and fails to produce a cell mediated immune response comprising elevated levels of IFN-γ and detectable, antigen-specific neutralizing antibody titers when administered intranasally via the nasal mucosa.