Human rotavirus strains and vaccines
Inventors
Jiang, Baoming • Glass, Roger I. • Wang, Yuhuan • Gentsch, Jon
Assignees
US Department of Health and Human Services
Publication Number
US-11065327-B2
Publication Date
2021-07-20
Expiration Date
2030-05-12
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Abstract
A vaccine composition and method of vaccination are provided useful for immunizing a subject against a rotavirus. The vaccines include rotavirus strains CDC-9 and CDC-66, fragments thereof, homologues thereof, or combinations thereof. Inventive vaccines may include a fragment of CDC-9, CDC-66, homologues thereof, or combinations thereof. Methods of inducing an immunological response are provided by administering an inventive vaccine.
Core Innovation
The invention provides vaccine compositions and methods of vaccination useful for immunizing a subject against rotavirus A. The vaccines include novel human rotavirus A strains identified as CDC-9 and CDC-66, fragments thereof, homologues thereof, or combinations thereof. The vaccines may contain live attenuated or inactivated forms of these strains and may include one or more strains having various G and P group serotypes.
The problem addressed by the invention is the continuing need for effective vaccines against diverse human rotavirus A strains, especially both common and less common types such as G1 and G2 serotypes. Existing vaccines have limitations including reduced efficacy in some regions and suspension or decline in availability. There is also a need for vaccines capable of generating immunity against multiple strains due to the genetic and serotypic diversity of rotavirus A.
Claims Coverage
The patent contains one independent claim describing an isolated rotavirus non-structural protein (NSP) with specific sequence identity and amino acid characteristics. The claims focus on the isolated protein, immunogenic compositions including it, and methods of inducing immune responses using these compositions.
Isolated rotavirus NSP protein with defined sequence identity and amino acid substitutions
An isolated NSP protein selected from NSP1 with >95% identity to SEQ ID NO: 3 and arginine at amino acid 122; NSP5 with >95% identity to SEQ ID NO: 15 with isoleucine at position 45 or SEQ ID NO: 96 with valine at position 60; and NSP2 with >95% identity to SEQ ID NO: 78 with tyrosine at position 142.
Immunogenic composition comprising the isolated NSP protein and carrier
An immunogenic composition including the defined isolated NSP protein and a pharmaceutically acceptable carrier, optionally further comprising an adjuvant.
Methods of inducing immune response using the immunogenic composition
Methods for inducing an immune response to rotavirus in a subject by administering an immunogenic amount of the said immunogenic composition via oral, parenteral, intramuscular, or intradermal routes.
The claims collectively cover the isolated rotavirus NSP proteins with specified sequence identities and amino acid markers, their use in immunogenic compositions, and methods for inducing immune responses in subjects by administering these compositions.
Stated Advantages
The vaccines and compositions provide immunological protection against diverse human rotavirus A serotypes including G1 and G2 types.
Vaccine formulations including aluminum-based adjuvants dramatically enhance antibody titers and protective immunity.
The inclusion of both CDC-9 and CDC-66 strains addresses the need for coverage against genetically distinct rotavirus lineages, potentially improving cross-protection.
Documented Applications
Vaccination of human subjects to induce an immunological response against rotavirus A infection and disease.
Use of inactivated or live attenuated rotavirus strains CDC-9 and CDC-66, or parts thereof, in vaccine compositions for prevention of rotavirus-mediated diarrhea.
Use of immunogenic fragments or homologues of rotavirus NSP proteins to produce protective immunity in subjects.
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