Zika virus vaccine
AssigneeValneva Austria GmbH
InventorsJana Barbero Calzado, Mario Nebenführ, Robert Schlegl, Michael Weber, Jürgen Heindl-Wruss
Life of this patent
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Abstract
Described herein are Zika virus vaccines and compositions and methods of producing and administering said vaccines to subjects in need thereof.
Claims33
-17. (canceled)
A Zika virus vaccine comprising a Zika virus having an RNA genome, wherein said Zika virus vaccine is capable of stimulating a neutralizing antibody titer greater than 15 in at least 70% of vaccinated subjects, wherein the neutralizing antibody titer is determined using a microneutralization assay (MN50) following a single administration of the Zika virus vaccine to a subject;
- and wherein the Zika virus comprises an E protein having an amino acid sequence having at least 95% sequence identity to any one of SEQ ID NOs:
- 14-69 and is able to pack a virulent Zika virus.
The Zika virus vaccine of claim 1, wherein the Zika virus comprises an E protein having an amino acid sequence having at least 96%, 97%, 98%, 99% or 99.5% sequence identity to any one of SEQ ID NOs:
- 14-69 and is able to pack a virulent Zika virus.
The Zika virus vaccine of claim 1, wherein the Zika virus comprises an E protein having an amino acid sequence having at least 95% sequence identity to SEQ ID NO:
- 47 or 48 and is able to pack a virulent Zika virus
The Zika virus vaccine of claim 1, wherein the Zika virus comprises an E protein having an amino acid sequence having at least 96%, 97%, 98%, 99% or 99.5% sequence identity to SEQ ID NO:
- 47 or 48 and is able to pack a virulent Zika virus
The Zika virus vaccine of claim 1, wherein the RNA genome corresponds to the DNA sequence provided by SEQ ID NO:
- 4 or a variant nucleic acid having at least 99% identity to SEQ ID NO:
- 4.
The Zika virus vaccine of claim 1, wherein said MN50 is greater than 20.
The Zika virus vaccine of claim 1, wherein said MN50 is greater than 30.
The Zika virus vaccine of claim 1, wherein said MN50 is greater than 40.
The Zika virus vaccine of claim 1, wherein said MN50 is greater than 50.
The Zika virus vaccine of claim 1, wherein said MN50 is greater than 60.
The Zika virus vaccine of claim 1, wherein said MN50 is greater than 70.
The Zika virus vaccine of claim 1, wherein said MN50 is greater than 80.
The Zika virus vaccine according to claim 1, wherein said MN50 is greater than or equal to 90.
The Zika virus vaccine of claim 1, wherein the Zika virus vaccine is capable of stimulating an MN50 titer greater than 15 in at least 80% of vaccinated subjects.
The Zika virus vaccine of claim 1, wherein the Zika virus vaccine is capable of stimulating an MN50 titer greater than 15 in at least 90% of vaccinated subjects.
The Zika virus vaccine of claim 1, wherein the Zika virus vaccine is capable of stimulating an MN50 titer greater than 15 in at least 95% of vaccinated subjects.
The Zika virus vaccine of claim 1, wherein the Zika virus vaccine is capable of stimulating an MN50 titer greater than 15 in at least 99% of vaccinated subjects.
The Zika virus vaccine of claim 1, wherein the Zika virus is inactivated by chemical inactivation, thermal inactivation, pH inactivation, or UV inactivation.
The Zika virus vaccine of claim 1, further comprising an adjuvant.
The Zika virus vaccine of claim 1, further comprising one or more pharmaceutically acceptable excipients.
The Zika virus vaccine of claim 1, wherein the vaccine comprises protamine sulphate (PS) or fragments or break-down products of PS at amounts below the limits of detection by high performance liquid chromatography (HPLC).
The Zika virus vaccine of claim 1, wherein the vaccine comprises protamine sulphate (PS) or fragments or break-down products of PS at amounts below 1 μg/mL or below 100 ng/mL.
Dependencies are inferred from the claim text.