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Publication Number
US-12605437-B2
Publication Date
2026-04-21
Expiration Date
Abstract
The present invention relates to a single-shot live attenuated vaccine against Chikungunya virus which is well-tolerated and induces long-lasting protective immunity in adult human subjects.
Core Innovation
The invention provides a lyophilized pharmaceutical unit dosage composition that is lyophilized from a composition comprising an attenuated Chikungunya virus (CHIKV), together with defined stabilizers and excipients: 5% (w/v) sucrose, 5 mM potassium phosphate, 25 mM sodium citrate, 5 mM MgCl2, 0.5% (w/v) D-sorbitol, 10 mM L-methionine, and 0.01% (w/v) recombinant human serum albumin (rHSA). The unit dosage composition includes 10^3 to 5×10^4 TCID50 per dose and is directed to a specific attenuated CHIKV genome defined by SEQ ID NO:1 (CHIKV-ΔnsP3) and/or variants thereof.
The attenuated CHIKV includes an RNA genome corresponding to the DNA sequence defined by SEQ ID NO:1 (CHIKV-ΔnsP3) and/or one or more variants, where the variant has a nucleic acid sequence at least 99% identical to SEQ ID NO:1 while preserving the entire 60 amino acid deletion in nsP3 as in SEQ ID NO:1. The document further emphasizes controlling immunogenicity-reducing mutations in the E2 protein, including E168K and optional E2 variants such as G55R, E247K, G82R, and H232Y, by using a heterogeneous particle mixture with defined proportions.
In background and rationale, the document states that neutralizing antibodies correlate with protection, and it reports preclinical and phase 1 findings for the single-shot live-attenuated CHIKV vaccine candidate CHIKV-ΔnsP3-inv in adult humans. Reported outcomes include 100% seroconversion by Day 14 with high GMTs by Day 28, delayed/reduced viremia after vaccination, no detectable viremia after human challenge at Day 180/Month 12, minimal shedding, and substantially reduced adverse events after challenge.
Claims Coverage
The provided content includes one independent claim. The independent claim centers on the formulation and specified genetic features of an attenuated CHIKV lyophilized unit dosage composition, delivering 10^3 to 5×10^4 TCID50 per dose, with genome identity and preservation of the entire 60 amino acid nsP3 deletion as in SEQ ID NO:1.
Lyophilized unit dose composition with defined CHIKV stabilizers
A lyophilized pharmaceutical unit dosage composition lyophilized from a composition comprising an attenuated Chikungunya virus (CHIKV); 5% (w/v) sucrose; 5 mM potassium phosphate; 25 mM sodium citrate; 5 mM MgCl2; 0.5% (w/v) D-sorbitol; 10 mM L-methionine; and 0.01% (w/v) recombinant human serum albumin (rHSA), wherein the unit dosage composition comprises 10^3 to 5×10^4 TCID50/dose.
Attenuated CHIKV genome corresponding to SEQ ID NO:1 with preserved nsP3 60 amino acid deletion
The attenuated CHIKV comprises an RNA genome corresponding to the DNA sequence as defined by SEQ ID NO:1 (CHIKV-ΔnsP3) and/or one or more variants thereof, wherein said variant has a nucleic acid sequence that is at least 99% identical to SEQ ID NO:1 and has the entire 60 amino acid deletion in nsP3 as in SEQ ID NO:1.
Overall, claim coverage in the provided material is directed to a lyophilized unit dosage composition with specific excipient/stabilizer components and a defined attenuated CHIKV genome requirement, formulated to deliver 10^3 to 5×10^4 TCID50 per dose.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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