Combination purified inactivated vaccine for flaviviruses
Inventors
Thomas, Stephen J. • Eckels, Kenneth H. • Putnak, Joseph R.
Assignees
Walter Reed Army Institute of Research • United States Department of the Army
Publication Number
US-10086061-B2
Publication Date
2018-10-02
Expiration Date
2036-03-10
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Abstract
Immunogenic compositions comprising one or more inactivated dengue viruses and one or more inactivated non-dengue flaviviruses and methods of making and using thereof are provided.
Core Innovation
The invention provides immunogenic compositions comprising one or more inactivated dengue viruses and one or more inactivated non-dengue flaviviruses, formulated with a pharmaceutically acceptable vehicle. These compositions can consist of mixtures of purified or non-purified viruses and optionally include adjuvants to enhance immunogenicity. The dengue viruses included may represent one or more serotypes out of DENV-1, DENV-2, DENV-3, and DENV-4, produced from specific ATCC deposited strains. The inactivated non-dengue flaviviruses include viruses from the yellow fever, Japanese encephalitis, West Nile, and Zika virus groups.
Prior to this invention, it was unknown whether vaccination with combinations of different flavivirus species would result in immunologic interference, potentially diminishing vaccine efficacy. Such interference had been observed in other virus groups and with some evidence in flavivirus infections. The invention addresses this by providing mixtures of inactivated dengue viruses and non-dengue flaviviruses that elicit protective immune responses without immunologic interference when administered to subjects.
The compositions are useful for inducing antibodies to both dengue virus and non-dengue flaviviruses in a subject after administration, generally by intramuscular injection following schedules such as a 0-28 day regimen. The invention encompasses methods of producing antibodies, medicaments for immunization, and uses of these compositions to immunize subjects at risk of exposure to one or more flaviviruses.
Claims Coverage
The patent contains multiple independent claims covering immunogenic compositions, methods of producing antibodies, and uses of the compositions. The analysis identifies four independent inventive features.
Immunogenic composition comprising inactivated dengue and non-dengue flaviviruses with adjuvant
An immunogenic composition comprising one or more inactivated dengue viruses and one or more inactivated non-dengue flaviviruses selected from yellow fever group viruses, Japanese encephalitis group viruses, and Zika virus, combined with an adjuvant and a pharmaceutically acceptable vehicle.
Method of producing antibodies by administering the composition
A method of producing antibodies against dengue virus and non-dengue flavivirus in a subject by administering to the subject the claimed immunogenic composition, including scheduling on Day 0 and Day 28, and administration by intramuscular injection.
Medicament for producing antibodies comprising the immunogenic composition
A medicament comprising the immunogenic composition of inactivated dengue and non-dengue flaviviruses, an adjuvant, and a pharmaceutically acceptable vehicle for producing antibodies against dengue virus and non-dengue flavivirus in a subject.
Use of immunogenic composition without immunologic interference
Use of an immunogenic composition comprising inactivated dengue viruses and inactivated non-dengue flaviviruses (yellow fever virus group viruses and Japanese encephalitis virus group viruses) that does not result in immunologic interference when administered to a subject.
The claims collectively cover compositions combining multiple inactivated dengue serotypes with one or more inactivated non-dengue flaviviruses formulated with adjuvants, methods and medicaments for inducing antibody responses, and demonstrate the compositions do not cause immunologic interference upon administration.
Stated Advantages
The compositions provide protective immune responses against multiple flaviviruses without immunologic interference.
They simplify immunization schedules by enabling combined vaccination against dengue and non-dengue flaviviruses in a single composition.
They can be administered in fewer doses, potentially improving compliance and protection timing.
Documented Applications
Use as vaccines to immunize subjects, including humans and non-human animals, against one or more dengue viruses and one or more non-dengue flaviviruses in endemic and at-risk areas.
Administration of the immunogenic compositions by intramuscular injection on a 0-28 day schedule to induce protective antibodies.
Use in protecting military personnel and travelers at risk of flavivirus exposure by providing a single vaccine composition effective against multiple flaviviruses.
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