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-9498526-B2
Publication Date
2016-11-22
Expiration Date
2032-05-12
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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 a subject against rotavirus using rotavirus strains CDC-9 and CDC-66, or fragments or homologues thereof. The vaccines include one or more isolated human rotavirus A strains with specific G and P serotypes, optionally admixed with a pharmaceutically acceptable carrier and optionally including an adjuvant. Methods to induce an immunological response involve administering these vaccine compositions, which may be live attenuated or inactivated rotavirus, parenterally or orally.
The problem addressed is the significant mortality caused by rotavirus-induced diarrhea in children worldwide, with about 611,000 deaths annually. Current vaccines have limitations, including reduced efficacy against certain genogroups, such as G2 strains, and issues of cross-protection. Additionally, safety concerns have led to suspension of some vaccines, decreasing available options while the need for robust vaccines capable of generating immunity against diverse strains remains.
Claims Coverage
The claims include multiple inventive features centered on vaccine compositions and methods involving specific inactivated rotavirus strains CDC-9 or CDC-66 and use of an adjuvant.
Vaccine composition comprising inactivated CDC-9 or CDC-66 rotavirus strain and adjuvant
A vaccine composition for inducing an immunological response against rotavirus comprising a pharmaceutically acceptable carrier admixed with an isolated CDC-9 or CDC-66 rotavirus strain inactivated by UV light treatment, and an adjuvant amount sufficient to increase immunogenicity of the strain.
Vaccine composition including multiple isolated rotavirus strains with specific serotypes
A vaccine composition including at least two isolated rotavirus strains each independently having G group serotypes among G1 to G14, or P group serotypes including P1A, P1B, P2A, P3, P4, P5, P6, P8, P11 or P12, with adjuvant enhancing immunogenicity of these strains.
Formulation for diverse administration routes
The vaccine composition is formulated for either parenteral or oral administration to a subject.
Method of inducing immunological response using the vaccine composition
A method involving administration of the vaccine composition comprising inactivated CDC-9 or CDC-66 rotavirus strains and an adjuvant to induce an immunological response against rotavirus in a subject.
The claims cover vaccine compositions with UV-inactivated CDC-9 or CDC-66 rotavirus strains combined with adjuvants enhancing immunogenicity, including formulations with multiple strains of defined G and P serotypes, usable via parenteral or oral routes, and corresponding methods of inducing immune response by administering such compositions.
Stated Advantages
The vaccine formulations induce strong immunological responses, including neutralizing antibodies and total antibody responses, as demonstrated in mouse and gnotobiotic piglet models.
The use of aluminum-based adjuvants significantly enhances the immunogenicity of rotavirus vaccines.
Combination of inactivated rotavirus strains and adjuvants provides effective protection against virus shedding and infection in animal models.
Documented Applications
Immunization of human subjects against rotavirus A infection to prevent rotavirus-mediated disease and associated symptoms.
Formulation and administration of vaccine compositions to induce active immunity using inactivated or live attenuated human rotavirus A strains CDC-9 and CDC-66, or their polypeptides, homologues or fragments.
Use in vaccine production involving large scale virus culture, purification, and preparation with adjuvants for human vaccination.
Administration routes including intramuscular, oral, parenteral, mucosal, nasal, intradermal, and subcutaneous vaccination.
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