HPV vaccine

Inventors: Marian E. Gindy (Haledon, NJ); John P. Bilello (San Carlos, CA); Amy S. Espeseth (Chalfont, PA); Andrew J. Bett (Lansdale, PA); Tong-Ming Fu (Philadelphia, PA)

Assignee: Merck Sharp & Dohme LLC

A61K39/39 A61K39/12 A61P31/20 C12N7/00 A61K2039/5258 A61K2039/545 A61K2039/55505 A61K2039/55555 A61K2039/55572 C12N2710/20023 C12N2710/20034 C12N2710/20071

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Quick Facts

Patent No.: US 12673103
App. No.: 17/799,464
Granted: Jul 7, 2026
Kind: B2

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Abstract

The present disclosure provides, among other things, a pharmaceutical composition that includes a lipid nanoparticle adjuvant and an anti-human papillomavirus (HPV) comprising HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.

Claims (35)

1 . A pharmaceutical composition comprising:

virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82,

a lipid nanoparticle (LNP) adjuvant, and

a pharmaceutically acceptable carrier.

2 . A pharmaceutical composition comprising:

(a) virus like particles (VLPs) of at least one type of human papillomavirus (HPV), wherein the at least one type of HPV is selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82;

(b) about 100 μg to about 900 μg of an aluminum adjuvant; and

wherein each of the HPV VLPs comprise recombinant L1 or recombinant L1+L2 protein;

wherein each of the HPV VLPs are present in a concentration of about 10 μg to about 100 μg per 0.5 mL of the pharmaceutical composition;

wherein the total HPV VLP concentration is between 10 μg and 2000 μg per 0.5 mL of the pharmaceutical composition; and

wherein the HPV VLPs are adsorbed onto the aluminum adjuvant.

3 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition comprises HPV VLPs of at least HPV types 16 and 18.

4 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition comprises HPV VLPs of at least HPV types 6, 11, 16, and 18.

5 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition comprises HPV VLPs of at least HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

6 . The pharmaceutical composition of claim 2 , wherein the LNP adjuvant comprises 30-65 mole % cationic lipid, 5-30 mole % phospholipid, 10-40 mole % cholesterol, and 0.5-4 mole % polyethylene glycol lipid (PEG-lipid).

7 . The pharmaceutical composition of claim 6 , wherein the LNP adjuvant comprises 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC), cholesterol, ePEG2000-DMG (dimyristolglycerol), and (13Z, 16Z)-N, N-dimethyl-3-nonyldocosa 13, 16-dien-1-amine.

8 . The pharmaceutical composition of claim 7 , wherein the LNP adjuvant comprises 5-15 mole % 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC), 25-35 mole % cholesterol, 1-2.5 mole % ePEG2000-DMG (dimyristolglycerol), and 55-65 mole % (13Z, 16Z)-N, N-dimethyl-3-nonyldocosa 13, 16-dien-1-amine.

9 . The pharmaceutical composition of claim 2 , wherein the HPV VLPs comprise HPV L1 protein and do not comprise HPV L2 protein.

10 . The pharmaceutical composition of claim 2 , wherein the HPV VLPs consists of HPV L1 protein.

11 . A method of inducing an immune response to a human papillomavirus (HPV) in a human patient comprising administering to the patient the pharmaceutical composition of claim 2 .

12 . A method of inducing an immune response to a human papillomavirus (HPV) in a human patient comprising co-administering to the patient (a) a pharmaceutical composition comprising virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82 and (b) an LNP adjuvant.

13 . A method of preventing infection of a human patient by a human papillomavirus (HPV) comprising administration to the patient the pharmaceutical composition of claim 2 .

14 . A method of preventing infection of a human patient by a human papillomavirus (HPV) comprising co-administering to the patient (a) a pharmaceutical composition comprising virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82 and (b) an LNP adjuvant.

15 . A kit comprising:

(a) a human papilloma virus (HPV) vaccine comprising virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82; and

(b) an LNP adjuvant.

16 . The kit of claim 15 , further comprising instructions for administering to a human patient the HPV vaccine and the LNP adjuvant.

17 . A method of delivering a pharmaceutical composition that induces a neutralizing titer against an HPV antigen in a host comprising:

(a) administering a pharmaceutical composition comprising:

a lipid nanoparticle (LNP) adjuvant, and

and

(b) inducing a neutralizing titer against the HPV antigen in the host,

where a single dose of the pharmaceutical composition provides enhanced or comparable neutralizing titers when compared to multiple doses of the same pharmaceutical composition when the anti-HPV composition is formulated without an adjuvant.