Synthetic polypeptide epitope based vaccine composition
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Publication Number
US-11273215-B2
Publication Date
2022-03-15
Expiration Date
Abstract
Conserved epitopes selected from EV71 and CVA16, the two major causative agents of Hand Foot and Mouth Disease has been used to develop sub-unit bivalent vaccine antigen construct. The said vaccine described in this invention is capable to provide cross-protection to diverse EV71 and CVA16 infection causing strains. Further disclosed are the expression of the multi-epitope vaccine antigen coding gene and the purification process involved thereof. This present invention also discloses vaccine formulations against Hand Foot and Mouth Disease and other enterovirus infections comprising the recombinant vaccine antigen construct of the present invention.
Core Innovation
The invention relates to an immunogenic composition for inducing an immune response against Hand Foot and Mouth Disease caused by EV71 and CA16. The composition comprises an antigen selected from recombinant protein sequences represented by SEQ ID No. 2 (MEV1) and SEQ ID No. 4 (MEV2), each being a synthetic construct. MEV1 and MEV2 are multi-epitope synthetic vaccine antigens built from conserved EV71/CVA16 capsid epitopes, enabling cross-reactivity against EV71 and CVA16/CA16.
The invention addresses a stability and formulation problem for such immunogenic compositions. It includes one or more adjuvants, one or more stabilizers, and a physiologically acceptable buffer selected from phosphate or citrate buffer. The composition is stable for at least 2 years at 5–3°C and up to 2 weeks at 37°C, enabling sustained formulation viability under the stated storage conditions.
The invention further includes high-purity antigen constructs corresponding to MEV1 and MEV2. The compositions can include multi-epitope synthetic protein sequences corresponding to SEQ ID No. 2 and SEQ ID No. 4, with purity levels specified in the claims. Documented results indicate immunogenicity and cross-reactivity, including binding to EV71 and CVA16 by immunofluorescence and functional PRNT50 neutralization, supporting the intended immune response against both EV71 and CA16.
Claims Coverage
The provided content includes three independent claims total: one immunogenic-composition claim focused on the MEV1/MEV2 synthetic construct antigen, formulation components, and stability requirement, plus two composition claims focused on the MEV sequences and purity thresholds.
Stable immunogenic composition with MEV1 or MEV2 antigen and specified buffer
An immunogenic composition comprising an antigen that is a synthetic construct selected from the recombinant protein sequences represented by SEQ ID No. 2 (MEV1) and SEQ ID No. 4 (MEV2), one or more adjuvants, one or more stabilizers, and a physiologically acceptable buffer selected from phosphate or citrate buffer, wherein the immunogenic composition is stable for at least 2 years at 5–3°C and up to 2 weeks at 37°C.
Multi-epitope synthetic protein sequence SEQ ID No. 2 purity
A composition comprising a multi-epitope synthetic protein sequence as disclosed in SEQ ID No. 2, the composition having at least 92%-96% purity.
Multi-epitope synthetic protein sequence SEQ ID No. 4 purity
A composition comprising a multi-epitope synthetic protein sequence as disclosed in SEQ ID No. 4, the composition having at least 96% purity.
The coverage centers on immunogenic compositions containing synthetic MEV1/MEV2 antigen constructs (SEQ ID No. 2 and SEQ ID No. 4) formulated with adjuvants, stabilizers, and a phosphate or citrate buffer, together with a defined stability requirement, as well as compositions defined by MEV sequence identity with specified purity thresholds.
Stated Advantages
The immunogenic composition is stable for at least 2 years at 5–3°C and up to 2 weeks at 37°C.
Cross-reactivity and neutralization against EV71 and CA16 are supported by documented immunogenicity results including binding to both EV71 and CVA16 and PRNT50 neutralization.
Documented Applications
Inducing an immune response against Hand Foot and Mouth Disease caused by EV71 and CA16 using the stated immunogenic compositions.
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