Human rotavirus G9P[6] strain and use as a vaccine
Inventors
Assignees
US Department of Health and Human Services
Publication Number
US-10548970-B2
Publication Date
2020-02-04
Expiration Date
2036-09-28
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Abstract
Attenuated G9P[6] rotavirus is disclosed herein. In some embodiments, pharmaceutical compositions are disclosed that include an attenuated G9P[6] rotavirus, or a component thereof. These compositions can be used to induce an immune response, such as a protective immune response, to a rotavirus. The compositions can be used as vaccines, such as for children (infants), for example in a prime boost strategy.
Core Innovation
The invention discloses an attenuated G9P[6] rotavirus and pharmaceutical compositions including the attenuated G9P[6] rotavirus or its components to induce an immune response to rotavirus. These compositions can be used as vaccines, for example, in children (infants) and may be administered in prime boost strategies. The compositions may include an adjuvant and/or an inactivated G1P[8] rotavirus such as CDC-9.
The invention addresses the problem that while rotavirus is a common cause of diarrhea in children worldwide, with significant morbidity and mortality, existing vaccines such as ROTARIX exhibit lower efficacy against certain DS-1 like strains in some regions. Additionally, diversity in human rotavirus types including less common types necessitates vaccines that can induce immunity against a broader range of rotavirus strains. The disclosed attenuated G9P[6] rotavirus provides a new strain suitable for vaccine development to overcome these limitations.
Claims Coverage
The patent includes 23 claims with multiple claims directed to an isolated attenuated G9P[6] rotavirus, pharmaceutical compositions containing it, and methods for inducing an immune response. The main inventive features relate to the structural and genetic characteristics of the attenuated rotavirus, its high titer growth, formulation in compositions with adjuvants or additional rotavirus strains, and methods of administration for immunization.
Isolated attenuated G9P[6] rotavirus having specific nucleic acid and polypeptide sequences
The rotavirus includes nucleic acid molecules encoding polypeptides comprising amino acid sequences at specified high sequence identities (e.g. VP1 at least 99.8% identical to SEQ ID NO: 1, VP4 at least 99.1% identical to SEQ ID NO: 4, VP7 at least 98.9% identical to SEQ ID NO: 6, etc.) and corresponding sequence identifiers. The virus is characterized as a G9P[6] rotavirus.
Attenuated rotavirus with high in vitro growth titer
The isolated attenuated rotavirus grows to a titer of 10^7 to 10^8 when propagated in host cells in vitro.
Pharmaceutical composition comprising the attenuated rotavirus and optionally adjuvants or additional rotavirus strains
Compositions include the isolated attenuated rotavirus with a pharmaceutically acceptable carrier, may contain an adjuvant such as an aluminum adjuvant, and optionally an inactivated G1P[8] rotavirus like heat inactivated CDC-9.
Method of inducing immune response via administration of the pharmaceutical compositions
Methods include administering an effective amount of the pharmaceutical composition containing the attenuated G9P[6] rotavirus to a subject, inducing a protective immune response. Administration can be oral or parenteral and may include prime and boost dosing schedules. A G1P[8] rotavirus may also be administered.
The claims cover an isolated attenuated G9P[6] rotavirus defined by specific nucleic acid and amino acid sequences, its ability to grow to high titers, pharmaceutical compositions including this virus optionally with adjuvants or additional virus strains, and methods of immunization in subjects, particularly children, to induce a protective immune response against rotavirus infection.
Stated Advantages
An attenuated G9P[6] rotavirus can induce immune responses without causing diarrhea.
The vaccine can induce immune responses against more than one type of rotavirus, including homotypic and heterotypic strains.
The disclosed attenuated G9P[6] rotavirus grows to high titers (10^7 to 10^8 ffu/ml) allowing for effective vaccine production.
The compositions can be formulated for oral or parenteral administration and combined with adjuvants and other vaccines to enhance immune response.
Documented Applications
Vaccine compositions for immunizing subjects, particularly children less than 5 years or 1 year of age, against rotavirus infection using an attenuated G9P[6] rotavirus.
Pharmaceutical compositions including attenuated or inactivated G9P[6] rotavirus to induce protective immune responses to homotypic and heterotypic rotavirus strains.
Methods for immunization employing oral or parenteral administration of vaccines including the attenuated G9P[6] rotavirus with prime/boost schedules.
Combination vaccines including the attenuated G9P[6] rotavirus with inactivated G1P[8] rotavirus (e.g., CDC-9) and other pathogen antigens such as diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, polio and pneumococcal disease for broader immunization.
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