Method of safe administration of phosphorylated tau peptide vaccine
AssigneesAC Immune SA, Janssen Pharmaceuticals, Inc.
InventorsAndrea Pfeifer, Andreas Muhs, Maria Pihlgren Bosch, Marija Vukicevic Verhille, Nicolas Piot, Saroj Raj Ghimire, Elizabeth Anne Ramsburg, Donata De Marco, Charlotte Sadaka
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Abstract
Methods for inducing anti-phosphorylated Tau antibodies without inducing a severe adverse event in humans are described. The methods include administering to the subject an effective amount of liposomes including a toll-like receptor 4 agonist and a Tau phosphopeptide presented on the surface of the liposome.
Claims20
A method of inducing anti-phosphorylated Tau antibodies without inducing a severe adverse event in a human subject in need thereof, comprising administering to the subject an effective amount of liposomes comprising a toll-like receptor 4 agonist and a Tau phosphopeptide comprising an amino acid sequence selected from the group consisting of SEQ ID NO:1 to SEQ ID NO:3 and SEQ ID NO:5 to SEQ ID NO:12, wherein the Tau phosphopeptide is administered to the human subject at an amount of about 25 nmoles to about 750 nmoles per dose, and the Tau phosphopeptide is presented on the surface of the liposome.
A method of inducing anti-phosphorylated Tau antibodies without inducing a severe adverse event in a human subject in need thereof, comprising administering to the subject an effective amount of liposomes comprising:
- (1) a Tau phosphopeptide having the amino acid sequence of SEQ ID NO:28;
- (2) a toll-like receptor 4 agonist comprising monophosphoryl hexa-acyl Lipid A, 3-deacyl;
- (3) a helper T-cell epitope comprising the amino acid sequence of SEQ ID NO:
- 39;
- (4) a lipidated CpG oligonucleotide comprising the nucleotide sequence of SEQ ID NO:18;
- and
- (5) at least one lipid selected from the group consisting of 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC), 1,2-dimyristoyl-sn-glycero-3-phosphoryl-3′-rac-glycerol (DMPG), and cholesterol,
- wherein the effective amount of liposomes comprises 300 μg to 2400 μg per dose of the Tau phosphopeptide, 100 μg to 585 μg per dose of the toll-like receptor 4 agonist, 75 μg to 450 μg per dose of the helper T-cell epitope, and 150 μg to 800 μg per dose-lipidated CpG oligonucleotide.
Dependencies are inferred from the claim text.