Non-gelatin vaccine protectant composition and live attenuated influenza vaccine

• US 10,463,741 B2
• Filed: 04/26/2016
• Issued: 11/05/2019
• Est. Priority Date: 06/02/2015
• Status: Active Grant

• Current Assignee: Changchun BCHT Biotechnology Co. (Changchun High & New Technology Industries (Group), Inc.)
• Original Assignee: Changchun BCHT Biotechnology Co. (Changchun High & New Technology Industries (Group), Inc.)
• Inventors: Shen, Zhenwei, Chen, Xiaohui, Xu, Fei, Sun, Yao, Cheng, Xiaogeng, Zhu, Changlin, Jiang, Chunlai, Kong, Wei
• Primary Examiner(s): Gill, Rachel B
• Application Number:
  US15/578,124
• Publication Number:
  US 20180154004A1
• Time in Patent Office: 1,288 Days
• CPC Class Codes: A61K 2039/5254 avirulent or attenuated
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/543 intranasal
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/16 containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: C12N 2760/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16234 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Abstract

The present invention provides a composition for use as the protectant for a live attenuated influenza virus vaccine, comprising the following components at the following concentrations: human serum albumin: 1.0-15.0 g/L, sugar: 15.0-95.0 g/L, and sodium glutamate: 0.5-15.0 g/L. The present invention also provides a process for preparing a live attenuated influenza vaccine with the composition according to the present invention, comprising the following steps: dissolving the components of the composition according to the present invention sequentially into a pH buffer solution, adjusting the pH to a specified value, performing filtration sterilization, and adding virus stock to give the live attenuated influenza vaccine. The present invention further provides a live attenuated influenza vaccine, which may be used as an injection or nasal spray.

Claims

1. A live influenza attenuated vaccine, comprising a protectant and influenza virus stock, wherein the protectant consists of the following components at the following concentrations:

Human serum albumin;

1.0-15.0 g/L, sucrose;

15.0-95.0 g/L, sodium glutamate;

0.5-15.0 g/L, urea at a concentration of 0.5-8.0 g/L, arginine at a concentration of 1.0-10.0 g/L, sorbitol at a concentration of 15.0-70.0 g/L, glycine at a concentration of 3.0-20.0 g/L, and mannitol at a concentration of 10.0-30.0 g/L;

wherein the vaccine has a pH of 6.0-8.0; and

wherein the human serum albumin is not recombinant human serum albumin.

2. The live influenza attenuated vaccine according to claim 1, wherein the vaccine may be used as an injection or nasal spray.

3. A process for preparing the live attenuated influenza vaccine according to claim 1, comprising the steps of:

1) dissolving the components of the protectant sequentially into a pH buffer solution,

2) adjusting the pH to 6.0-8.0,

3) performing filtration sterilization, and

4) adding virus stock to give the live attenuated influenza vaccine.

4. The process according to claim 3, wherein phosphate buffer is used as the pH buffer solution.