Method and kit for quantifying vaccine
Inventors
CHEN, Juine-Ruey • Wu, Chia-Ying • Chen, Yung-Tsung
Assignees
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Publication Number
US-10942181-B2
Publication Date
2021-03-09
Expiration Date
Abstract
The present disclosure provides a method for quantifying a vaccine. The method includes the steps of: 1) providing a plurality of standard mixtures, each of the standard mixtures having a standard antigen and an aluminum based adjuvant; 2) mixing a stabilizing solution with the vaccine and each of the standard mixtures; 3) determining dosages of the standard antigens in the standard mixtures to establish a standard curve; and 4) determining a dosage of a target antigen in the vaccine according to the standard curve.
Core Innovation
A method is provided for quantifying a vaccine containing an aluminum based adjuvant. The method includes providing a plurality of standard mixtures that contain a series of known concentration of standard antigens, mixing the aluminum based adjuvant with each standard mixture to produce a plurality of standard solutions, and mixing a stabilizing solution having a pH that falls within a range of 10 to 12 with the vaccine and with each of the standard solutions.
Dosages of the standard antigens in the standard are determined in order to establish a standard curve. A dosage of a target antigen in the vaccine is then determined according to the standard curve.
The disclosed embodiments include a stabilizing solution selected from sodium hydroxide, potassium hydroxide, calcium hydroxide, sodium bicarbonate, or ammonium hydroxide. The aluminum based adjuvant is exemplified by aluminum hydroxide, aluminum phosphate, and aluminum sulfate, and the approach is described in connection with an EV71 vaccine and other viral vaccine embodiments.
Claims Coverage
The independent claim is directed to a vaccine quantification method for vaccines containing an aluminum based adjuvant, using standard mixtures, an alkaline stabilizing solution (pH 10 to 12), and a standard-curve determination of a target antigen dosage. The independent claim includes five main inventive features; associated dependent claims refine the stabilizing solution selection, add a stabilizing-to-mixture volume ratio constraint, and optionally narrow quantification to immunoassay and vaccine context.
Standard mixtures with known concentration of standard antigens
Providing a plurality of standard mixtures containing a series of known concentration of standard antigens.
Aluminum adjuvant mixed with standard mixtures to form standard solutions
Mixing the aluminum based adjuvant with each of the standard mixtures to produce a plurality of standard solutions.
Alkaline stabilizing solution mixed with vaccine and standard solutions
Mixing a stabilizing solution having a pH falls within a range of 10 to 12 with the vaccine containing the aluminum based adjuvant, and mixing the stabilizing solution with each of the standard solutions.
Standard-curve establishment by determining dosages of standard antigens
Determining dosages of the standard antigens in the standard to establish a standard curve.
Target antigen dosage determined according to the standard curve
Determining a dosage of a target antigen in the vaccine according to the standard curve.
Overall, the claim coverage centers on constructing a standard-curve quantification workflow for aluminum-adjuvanted vaccines using an alkaline stabilizing condition, where target antigen dosage is determined from standard antigen dosing. Dependent refinements specify candidate alkaline stabilizers, add a stabilizing-to-standard-mixture volume ratio, and describe embodiments for EV71 and viral vaccines.
Stated Advantages
Enables quantitative determination of target antigen dosage in an aluminum-adjuvanted vaccine using a standard curve.
Maintains antigen detectability after stabilizing, as supported by the described retention of antigen detectability and antigen integrity checks.
Documented Applications
A vaccine quantification method applied to an EV71 vaccine and other viral vaccine embodiments containing an aluminum based adjuvant.
Use in establishing a standard curve by measuring standard antigen absorbance and determining dosage of a target antigen in the vaccine.
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