Compositions comprising three OspA fusion proteins for medical use

Patent metadata

Field	Value
Publication number	US-12514912-B2
Application number	US-202117917624-A
Country	US
Kind code	B2
Filing date	Apr 9, 2021
Priority date	Apr 9, 2020
Publication date	Jan 6, 2026
Grant date	Jan 6, 2026

Abstract

The present invention relates to a composition comprising the OspA fusion protein of SEQ ID NO: 1 (LipS1D1-S2D1), the OspA fusion protein of SEQ ID NO: 2 (Lip-S4D1-SShybD1) and the OspA fusion protein of SEQ ID NO: 3 (Lip-S5D1-S6D1) for use in a vaccine or for use in a method for eliciting an immune response in a human against Lyme disease.

First claim

The invention claimed is:

1 . A method of eliciting an immune response in a human adult or human child against Lyme disease, comprising administering a composition comprising: (a) a first fusion protein comprising the amino acid sequence of SEQ ID NO: 1 (Lip-S1D1-S2D1), (b) a second fusion protein comprising the amino acid sequence of SEQ ID NO: 2 (Lip-S4D1-S3hybD1), and (c) a third fusion protein comprising the amino acid sequence of SEQ ID NO: 3 (Lip-S5D1-S6D1):
(i) to a human adult or a human child at least two times or at least three times, wherein each dose of the composition comprises a total protein content of the three fusion proteins of 120 to 200 μg; or (ii) to a human child at least two times or at least three times, wherein each dose of the composition comprises a total protein content of the three fusion proteins of 60 to 100 μg, wherein the composition comprises the first, second, and third fusion proteins at a 1:1:1 weight ratio.

2 . The method of claim 1 , wherein the method comprises administering the composition at least three times, wherein:
(i) each dose of the composition administered to a human adult comprises a total protein content of the three fusion proteins of 135 to 180 μg, or (ii) each dose of the composition administered to a human child comprises a total protein content of the three fusion proteins of 67.5 to 90 μg.

3 . The method of claim 2 , wherein:
(i) each dose of the composition administered to a human adult comprises a total protein content of the three fusion proteins of 135 or 180 μg, or (ii) each dose of the composition administered to a human child comprises a total protein content of the three fusion proteins of 67.5 or 90 μg.

4 . The method of claim 1 , wherein the method comprises administering the composition at least three times, wherein the second administration is at least 6 weeks and at most 3 months after the first administration; and/or the third administration is at least 5 months and at most 7 months after the first administration.

5 . The method of claim 4 , wherein the second administration is at least 50 days to at most 70 days after the first administration; and/or the third administration is at least 170 days to at most 190 days after the first administration.

6 . The method of claim 1 , wherein the method comprises administering the composition at least three times, further comprising administering a fourth dose of the composition at least 15 months and at most 21 months after the first administration.

7 . The method of claim 1 , wherein the method comprises administering the composition at least two times, wherein:
(i) each dose of the composition administered to a human adult comprises a total protein content of the three fusion proteins of 135 μg to 180 μg, or (ii) each dose of the composition administered to a human child comprises a total protein content of the three fusion proteins of 67.5 μg to 90 μg.

8 . The method of claim 7 , wherein
(i) each dose of the composition administered to a human adult comprises a total protein content of the three fusion proteins of 135 μg or 180 μg, or (ii) each dose of the composition administered to a human child comprises a total protein content of the three fusion proteins of 67.5 μg or 90 μg.

9 . The method of claim 1 , wherein the method comprises administering the composition at least two times, wherein the second administration is at least 5 months to at most 7 months after the first administration.

10 . The method of claim 9 , wherein the second administration is at least 170 days to at most 190 days after the first administration.

11 . The method of claim 1 , wherein the method comprises administering the composition at least two times, further comprising administering a third dose of the composition at least 15 months and at most 21 months after the first administration.

12 . The method of claim 1 , wherein the first, second, and third fusion proteins represent at least 60%, at least 70%, or at least 80% of all proteins in the composition.

13 . The method of claim 1 , wherein the composition further comprises an adjuvant.

14 . The method of claim 1 , wherein the composition further comprises an aluminum adjuvant.

15 . The method of claim 1 , wherein the human adult is 18 years or older.

16 . The method of claim 1 , wherein the human child is 5-17 years old.

17 . The method of claim 1 , wherein the human child is a young child who is 0-4 years old.

18 . The method of claim 1 , wherein the composition is administered in a volume of 0.2 milliliter (mL) to 1.0 mL.

19 . The method of claim 1 , wherein the immune response elicited comprises an anti-OspA serotype 1, an anti-OspA serotype 2, an anti-OspA serotype 3, an anti-OspA serotype 4, anti-OspA serotype 5 and/or an anti-OspA serotype 6 antibody response with bactericidal activity.

20 . The method of claim 1 , wherein the immune response elicited comprises antibodies against Borrelia OspA serotypes 1, 2, 3, 4, 5 and 6.

21 . The method of claim 15 , wherein the human adult is 18-65 years old, and/or an elderly subject who is 50 years or older.

22 . The method of claim 16 , wherein the human child is 12-17 years old or 5-11 years old.

23 . The method of claim 17 , wherein the human child is a young child who is 1-4 years old or 2-4 years old.

24 . The method of claim 18 , wherein the composition is administered in a volume of 0.2 mL, 0.25 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, or 1.0 mL.

Assignees

• Valneva Austria Gmbh
• Pfizer

Inventors

• Bézay Nicole
• Hochreiter Romana
• Lundberg Urban
• Bailey Steven Russell
• Anderson Annaliesa Sybil
• Jansen Kathrin Ute
• Scott Daniel Alfred

Classifications

• A61K2039/55505

  Inorganic adjuvants · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61P37/04

  Immunostimulants · CPC title

• C07K2319/00

  Fusion polypeptide · CPC title

• A61K2039/70

  Multivalent vaccine · CPC title