Zika vaccines and immunogenic compositions, and methods of using the same
AssigneeTakeda Vaccines, Inc.
InventorsJill A Livengood, Hansi Dean, Htay Htay Han, Raman Rao, Jackie Marks, Gary Dubin, Laurence De Moerlooze, Hetal Patel, Sushma Kommareddy
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Abstract
The present disclosure relates to Zika virus vaccines and immunogenic compositions having one or more antigens from a Zika virus (e.g., a Zika virus clonal isolate, a non-human cell adapted Zika virus, etc.), and methods of treatments and uses thereof.
Claims67
A method of vaccinating against Zika virus infection in a human subject in need thereof,
- the method comprising administering to the human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus as a first (prime) and a second (boost) administration, wherein administration of the vaccine or immunogenic composition induces 14 and/or 28 days after the boost administration a seroconversion rate of at least 80% in a population of at least 20 Zika virus seronegative subjects.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the vaccine or immunogenic composition is administered as a first (prime) and a second (boost) administration.
A method of vaccinating against Zika virus infection in a human subject in need thereof,
- the method comprising administering to the human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, wherein the vaccine or immunogenic composition is administered one or more times, wherein administration of the vaccine or immunogenic composition induces 14 and/or 28 days after a single dose or prime administration a seroconversion rate of at least 60% in a population of at least 20 Zika virus seronegative subjects.
A method of vaccinating against Zika virus infection in a human subject in need thereof,
- the method comprising administering to the human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, wherein the vaccine or immunogenic composition comprises a dose of about 10 μg of purified inactivated whole virus, about 200 μg aluminum hydroxide, a buffer;
- and optionally a sugar.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the antigen is purified.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μs of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the vaccine or immunogenic composition comprises a dose of from about 10 μg to about 40 μg of purified inactivated whole virus.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the vaccine or immunogenic composition further comprises an aluminum salt adjuvant.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the Zika virus is a clonal isolate, in particular from a plaque purified clonal Zika virus isolate.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the vaccine or immunogenic composition comprises a dose of about 10 μg of purified inactivated whole virus, about 200 μg aluminum hydroxide, a buffer;
- and optionally a sugar.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the pregnant human subject is from a Zika endemic region or from a Zika non-endemic region travelling to an endemic region.
A method of vaccinating against Zika virus disease in a fetus or newborn in need thereof, the method comprising administering to a pregnant human subject a vaccine or immunogenic composition comprising a dose of from about 1 μg to about 40 μg of an antigen from a Zika virus, wherein the antigen is an inactivated whole virus, and wherein the pregnant human subject adoptively transfers a vaccine effective amount of neutralizing antibodies against Zika virus to the fetus or newborn, wherein the pregnant human subject is 18 to 29 years of age or 30 to 49 years of age.
Dependencies are inferred from the claim text.