Human rotavirus vaccine strains and diagnostics
Inventors
Jiang, Baoming • Glass, Roger I. • Wang, Yuhuan • Gentsch, Jon
Assignees
Centers of Disease Control and Prevention CDC • US Department of Health and Human Services
Publication Number
US-8822192-B2
Publication Date
2014-09-02
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 for immunizing subjects against rotavirus A infection. The vaccines include specific human rotavirus A strains, namely CDC-9 and CDC-66, or fragments, homologues, or combinations thereof. These vaccine compositions may contain live attenuated or inactivated rotavirus strains, and may optionally include adjuvants to enhance immunological response. The vaccines may be administered by parenteral or oral routes.
The problem addressed relates to the high global disease burden caused by rotavirus, which is the leading viral cause of severe diarrhea and death in children worldwide. Existing vaccines, such as ROTARIX and RotaTeq®, have limitations including decreased efficacy in low-income countries and safety concerns leading to suspension of vaccine use. Also, diversity of rotavirus strains limits cross-protective immunity, especially between G1 and G2 serotypes. Therefore, there is a continuing need for robust vaccines incorporating multiple rotavirus types, including strains from different serotype lineages, to improve protection against rotavirus-mediated disease.
Claims Coverage
The patent includes five independent claims covering vaccine compositions, isolated virus strains, and methods of immunization utilizing rotavirus strains CDC-9 and CDC-66, both inactivated and live attenuated forms.
Vaccine composition with inactivated CDC-9 or CDC-66 rotavirus strain
A vaccine composition comprising a pharmaceutically acceptable carrier admixed with an isolated rotavirus strain of CDC-9 or CDC-66 that has been inactivated by chemical and/or thermal treatment.
Isolated live attenuated or inactivated CDC-9 or CDC-66 rotavirus strains
An isolated rotavirus strain of CDC-9 or CDC-66, which can be live attenuated or inactivated by chemical and/or thermal inactivation, for use as immunogenic agents.
Method for inducing immunological response to rotavirus
A method of inducing an immunological response in a subject by administering the vaccine composition containing inactivated CDC-9 or CDC-66 rotavirus strain as described.
Immunogenic composition comprising CDC-9 or CDC-66 strains
An immunogenic composition comprising a pharmaceutically acceptable carrier admixed with either inactivated CDC-9 or CDC-66 rotavirus strain and/or isolated live attenuated CDC-9 or CDC-66 strains, optionally including an adjuvant.
Compositions comprising multiple rotavirus strains of defined serotypes
Vaccine or immunogenic compositions comprising at least two isolated rotavirus strains wherein at least one is CDC-9 or CDC-66 and the strains independently have defined G group serotypes (G1 to G14) and P group serotypes (P1A, P1B, P2A, etc.).
The claims cover vaccine compositions with inactivated or live attenuated CDC-9 or CDC-66 strains, compositions containing multiple rotavirus serotypes including CDC-9 and CDC-66, isolated virus strains, and methods of inducing immune responses by administering such compositions to subjects.
Stated Advantages
The vaccine formulations provide immunity against diverse rotavirus strains, including both G1 and G2 serotypes, improving breadth of protection.
The invention addresses the unmet need for effective rotavirus vaccines suitable for use in varied populations, particularly where existing vaccines have reduced efficacy.
Inactivated rotavirus vaccines formulated with adjuvants demonstrate enhanced immunogenicity and protective efficacy in animal models.
Documented Applications
Immunization of human subjects against rotavirus-mediated disease using vaccine compositions containing CDC-9 and/or CDC-66 strains to induce protective immunological responses.
Use as inactivated or live attenuated rotavirus vaccines administrable via parenteral or oral routes.
Production of vaccines including multiple rotavirus strains to elicit broad immunity against rotavirus A infections of various serotypes.
Use of specific rotavirus polypeptides, fragments or homologues from CDC-9 or CDC-66 strains as immunogens in vaccine formulations.
Preclinical testing in animal models such as mice and gnotobiotic piglets to evaluate immunogenicity and protective efficacy of vaccine compositions.
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