Preparation of zinc risedronate micro/nano adjuvant and use thereof as vaccine adjuvant

Patent metadata

Field	Value
Publication number	US-12419951-B2
Application number	US-202017615493-A
Country	US
Kind code	B2
Filing date	Mar 31, 2020
Priority date	May 30, 2019
Publication date	Sep 23, 2025
Grant date	Sep 23, 2025

Abstract

The present invention pertains to the field of pharmaceutical technology. Specifically, the present invention relates to a zinc risedronate micro/nano adjuvant with sustained-release function formed by mineralization of zinc ions and risedronic acid as main components and its use as a vaccine adjuvant. The present invention also relates to a method for preparing zinc risedronate micro/nano adjuvant. The present invention also relates to a chemical composition, vaccine adjuvant and vaccine composition comprising zinc risedronate micro/nano adjuvant. The present invention also relates to a use of zinc risedronate micro/nano adjuvant as a vaccine adjuvant.

First claim

What is claimed is:

1. A vaccination method for treatment or prevention of infection in a mammal, said method comprising administering a vaccine composition intramuscularly to a mammal, wherein said vaccine composition comprises an antigen and an adjuvant, the adjuvant comprising zinc risedronate micro/nanoparticles, wherein the zinc risedronate micro/nanoparticles consist of zinc and risedronic acid and, optionally phosphate, and wherein the zinc risedronate micro/nanoparticles have a molar concentration ratio of zinc: risedronic acid of 1-8:1.

2. The vaccination method according to claim 1 , wherein said zinc risedronate micro/nanoparticles have a molar concentration ratio of zinc: risedronic acid selected from 1:1, 4:1 and 8:1.

3. The vaccination method according to claim 1 , characterized in any one of the following:
(1) said zinc risedronate micro/nanoparticles consist of a phosphate at a molar concentration ratio of zinc: phosphate of 1-8:1; and
(2) said zinc risedronate micro/nanoparticles consist of a phosphate at a molar concentration ratio of zinc: phosphate selected from 1.5:1 and 4:1.

4. The vaccination method according to claim 1 , wherein the zinc risedronate micro/nanoparticles are prepared by a method comprising the following steps:
a) providing a soluble salt solution containing zinc ions;
b) evenly mixing the soluble salt solution of step a) with a risedronic acid and a sodium hydroxide; or
evenly mixing the soluble salt solution of step a) with a risedronic acid, a sodium hydroxide, and a sodium phosphate solution,

in a manner of sequential precipitation, separated precipitation followed by mixing, or co-precipitation, to obtain the adjuvant comprising zinc risedronate micro/nanoparticles.

5. The vaccination method according to claim 4 , characterized in one or more of the following:
(1) said soluble salt solution comprises a solution of hydrochloric acid; and
(2) said method further comprises subjecting the mixture of step b) to sterilization, and storing at 2° C. to 8° C. for later use.

6. The vaccination method according to claim 5 , characterized in any one of the following:
(1) said sterilization comprises a sterilization using a high temperature and high pressure sterilization technique; and
(2) said sterilization comprises a sterilization performed at 121° C. for 30 to 60 minutes.

7. The vaccination method according to claim 1 , characterized in one or more of the following:
(1) said adjuvant has a pH of 8.0-9.0 before sterilization;
(2) said adjuvant has a pH of 6.0-8.0 after sterilization;
(3) said zinc risedronate micro/nanoparticles have a particle size of 1-10 μm;
(4) said adjuvant has a particle zero charge point of 4.0-11.4; and
(5) said adjuvant has a protein adsorption rate of >60%.

8. The vaccination method according to claim 7 , wherein said protein comprises bovine serum albumin.

Assignees

• Univ Xiamen
• Xiamen Innovax Biotech Co Ltd

Inventors

• Zhao Qinjian
• Huang Xiaofen
• Li Yike
• Nie Meifeng
• Chen Siyi
• Xia Ningshao

Classifications

• A61K2039/55516

  Proteins; Peptides · CPC title

• A61K2039/55511

  Organic adjuvants · CPC title

• A61K39/25

  Varicella-zoster virus · CPC title

• A61P37/04

  Immunostimulants · CPC title

• A61P31/22 Primary

  for herpes viruses · CPC title