Compositions comprising three OspA fusion proteins for medical use
Inventors
Bézay, Nicole • Hochreiter, Romana • Lundberg, Urban • Bailey, Steven Russell • Anderson, Annaliesa Sybil • Jansen, Kathrin Ute • Scott, Daniel Alfred
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12514912-B2
Publication Date
2026-01-06
Expiration Date
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.
Core Innovation
The invention relates to a method of eliciting an immune response in a human adult or human child against Lyme disease by administering a composition containing three specific lipidated OspA fusion proteins. The composition comprises a first fusion protein comprising the amino acid sequence of SEQ ID NO: 1 (Lip-S1D1-S2D1), a second fusion protein comprising the amino acid sequence of SEQ ID NO: 2 (Lip-S4D1-S3hybD1), and a third fusion protein comprising the amino acid sequence of SEQ ID NO: 3 (Lip-S5D1-S6D1).
The composition further comprises the first, second, and third fusion proteins at a 1:1:1 weight ratio. Each dose includes a total protein content from the three fusion proteins, with adult doses comprising 120 to 200 μg and child doses comprising 60 to 100 μg. The method is based on administering the composition multiple times.
The disclosed approach focuses on administering the defined three-fusion-protein composition to produce anti-OspA antibody responses, including anti-OspA serotype antibodies with bactericidal activity. The background problem is the need for an elicited immune response against Lyme disease in humans.
Claims Coverage
The independent claim is a method for eliciting an immune response against Lyme disease in a human adult or human child using a composition with three defined fusion proteins. Four inventive features are present: the specific trio of lipidated OspA fusion proteins, their 1:1:1 weight ratio, differentiated total protein dose ranges for adults versus children, and multiple administrations.
Three defined lipidated OspA fusion proteins
A composition comprising a first fusion protein comprising the amino acid sequence of SEQ ID NO: 1 (Lip-S1D1-S2D1), a second fusion protein comprising the amino acid sequence of SEQ ID NO: 2 (Lip-S4D1-S3hybD1), and a third fusion protein comprising the amino acid sequence of SEQ ID NO: 3 (Lip-S5D1-S6D1).
1:1:1 weight ratio of fusion proteins
The composition comprises the first, second, and third fusion proteins at a 1:1:1 weight ratio.
Adult and child total protein dose ranges
For each dose, the total protein content of the three fusion proteins is 120 to 200 μg when administered to a human adult and 60 to 100 μg when administered to a human child.
Multiple administrations in humans for Lyme disease immune response
Administering the composition to a human adult or a human child at least two times or at least three times to elicit an immune response against Lyme disease.
The claim coverage is directed to eliciting a Lyme disease immune response in humans by administering the three specified fusion proteins (SEQ ID NOs 1–3) at a 1:1:1 weight ratio, with adult versus child differentiated total protein content per dose and multiple administrations.
Stated Advantages
Elicits an immune response against Lyme disease in a human adult or human child.
Induces anti-OspA antibody responses with bactericidal activity.
Provides dosing with total protein content tailored for adult versus child dosing ranges.
Documented Applications
A vaccine/multimeric Borrelia vaccine use for human vaccination against Lyme disease by administering the composition to elicit an immune response.
Interested in licensing this patent?