Zika virus vaccine and methods of production
Inventors
Thomas, Stephen J. • ENDY, Timothy • Eckels, Kenneth H. • Putnak, J. Robert • JARMAN, Richard • DE LA BARRERA, Rafael
Assignees
Government Of United States Represented By Secretary Of Army Fort Detrick Maryland AS • Research Foundation of the State University of New York • United States Department of the Army
Publication Number
US-11033615-B2
Publication Date
2021-06-15
Expiration Date
2037-05-30
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Abstract
The invention generally relates to a purified inactivated Zika virus (ZIKV), methods for producing the purified inactivated ZIKV, immunogenic compositions and vaccines comprising the purified inactivated ZIKV and methods for the prevention and/or treatment of infection by ZIKV.
Core Innovation
The invention describes a purified, inactivated Zika virus (ZIKV), including compositions and vaccines comprising the purified inactivated ZIKV, methods for producing it, and methods of using it for prevention, treatment, and immunization against ZIKV infection. The purified inactivated ZIKV is produced by purifying ZIKV strains to remove host cell proteins and adventitious agents following FDA guidelines, and then inactivating the virus using chemical agents such as formalin or beta-propiolactone. The resulting vaccine element is non-infectious but retains antigenicity and immunogenicity to induce a protective immune response in subjects at risk or infected with ZIKV.
The purified inactivated ZIKV vaccine offers advantages over live attenuated vaccines in safety—since inactivated viruses cannot revert to virulence or cause disease—and physical stability, allowing for easier storage and transport. The vaccine can induce virus-neutralizing antibodies sufficient for broad-based seroprotection against ZIKV strains worldwide. Immunization regimens include single or booster doses, similar to those used for other flavivirus vaccines such as Japanese encephalitis virus purified inactivated vaccines.
The problem addressed by the invention stems from the lack of approved or effective vaccines to prevent ZIKV infection or disease despite the severe outcomes associated with the virus, including congenital microcephaly and Guillain-Barré syndrome. ZIKV causes a mild disease phenotype in approximately 20% of infected individuals, but the recent outbreaks have increased the urgency for a vaccine that can prevent infection and adverse clinical outcomes. Existing vaccine candidates at the time were under development but had not demonstrated animal or human efficacy data, leaving an unmet need for a safe, effective vaccine.
Claims Coverage
The claims disclose multiple inventive features covering purified, inactivated ZIKV strains, immunogenic compositions, vaccines, methods of production, and methods of use, detailed across independent claims.
Purified inactivated immunogenic Zika virus from selected strains
The invention covers purified, inactivated, immunogenic ZIKV produced using specific strains including Puerto Rico PRVABC59, Thailand SVO127/14, Philippine COC C 0740, and Brazil Fortaleza/2015 strains.
Immunogenic compositions comprising purified, inactivated ZIKV and pharmaceutically acceptable adjuvants
The claims encompass immunogenic compositions that include the purified, inactivated ZIKV combined with pharmaceutically acceptable adjuvants such as alum to enhance immunogenicity.
Vaccines comprising purified, inactivated ZIKV and pharmaceutically acceptable adjuvants
Vaccines comprising the purified, inactivated ZIKV and pharmaceutically acceptable adjuvants, including alum, are claimed, enabling immunization of subjects against ZIKV infection.
Methods of inducing immune responses and protection against ZIKV
Methods of inducing protective immune responses or generating antibodies recognizing ZIKV by administering vaccines or immunogenic compositions comprising the purified, inactivated ZIKV, with various administration routes including intramuscular, intradermal, subcutaneous, intravenous, oral, or intranasal.
Methods of treating or alleviating symptoms of ZIKV infection
Methods for treating or alleviating symptoms of ZIKV infection by administering immunogenic compositions containing the purified, inactivated ZIKV are disclosed.
Methods of producing purified, inactivated ZIKV
Methods to produce purified, inactivated ZIKV involve steps including inoculating cell culture with ZIKV strain, propagating, harvesting virus fluids, purifying virus concentrate, inactivating the purified virus using chemical agents such as formalin, beta-propiolactone, or hydrogen peroxide, and recovering the purified, inactivated virus.
The claims comprehensively cover the purified, inactivated ZIKV from selected strains, its use in immunogenic compositions and vaccines with adjuvants, methods for immune induction and treatment of ZIKV infection, and detailed production methods involving purification and chemical inactivation.
Stated Advantages
Inactivated viruses are non-infectious and cannot revert to virulence or cause disease, enhancing safety particularly for special populations such as pregnant women or immunocompromised individuals.
Greater physical stability of the inactivated virus vaccine facilitates easy and economical transport and storage due to resistance to temperature changes.
Inactivated vaccines preserve native viral conformations, affording superior immunogenicity and greater protection against disease compared to attenuated vaccines.
Potential to rapidly induce protective immune responses capable of breaking viral transmission cycles both at the individual and population levels.
Documented Applications
Use as a vaccine composition to immunize mammals, including humans, to elicit protective virus-neutralizing antibodies against all strains of ZIKV.
Use in methods for preventing ZIKV infection, protection against disease symptoms, and treatment or alleviation of symptoms following ZIKV infection.
Production of antibodies recognizing ZIKV by administering immunogenic compositions comprising purified, inactivated ZIKV.
Use in passive immunization approaches demonstrated by adoptive transfer of antibodies from vaccinated primates or mice to naïve recipients for protection against ZIKV challenge.
Formulation with pharmaceutically acceptable adjuvants, such as alum, for enhanced immunogenicity and vaccine efficacy.
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