Granted Patent
B2
US 12,514,912 · App. 17/917,624 · Granted Jan 6, 2026
Compositions comprising three OspA fusion proteins for medical use
Inventors:
Nicole Bézay (Hinterbrühl, AT); Romana Hochreiter (Vienna, AT); Urban Lundberg (Pressbaum, AT); Steven Russell Bailey (Bryn Mawr, PA); Annaliesa Sybil Anderson (Upper Saddle River, NJ); Kathrin Ute Jansen (New York, NY); Daniel Alfred Scott (Spring City, PA)
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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.
Claims (35)
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.
Assignments (6)
AMENDED AND RESTATED PATENT SECURITY AGREEMENT
Recorded Mar 31, 2026
From: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA SWEDEN AB
To: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
Reel/Frame 075335/0609 →
RELEASE OF SECURITY INTEREST
Recorded Nov 10, 2025
From: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
To: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA USA, INC.
Reel/Frame 073516/0522 →
PATENT SECURITY AGREEMENT
Recorded Oct 20, 2025
From: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA SWEDEN AB
To: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
Reel/Frame 073164/0032 →
SECURITY INTEREST
Recorded Jan 19, 2024
From: VALNEVA SE; VALNEVA AUSTRIA GMBH; VALNEVA USA, INC.; VALNEVA SWEDEN AB
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 066182/0174 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 9, 2023
From: BÉZAY, NICOLE; HOCHREITER, ROMANA; LUNDBERG, URBAN
To: VALNEVA AUSTRIA GMBH
Reel/Frame 065512/0107 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 9, 2023
From: ANDERSON, ANNALIESA SYBIL; BAILEY, STEVEN RUSSELL; JANSEN, KATHRIN UTE; SCOTT, DANIEL ALFRED
To: PFIZER INC.
Reel/Frame 065512/0188 →
Priority Claims (5)
EP 20169147
· Apr 9, 2020
· regional
EP 20169148
· Apr 9, 2020
· regional
EP 20169642
· Apr 15, 2020
· regional
EP 20187283
· Jul 22, 2020
· regional
EP 20202816
· Oct 20, 2020
· regional
Continuity (2)
Provisional Application
63152582
· Feb 23, 2021
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