Liquid vaccines for live enveloped viruses

文档序号:1301176 发布日期:2020-08-07 浏览:10次 中文

阅读说明:本技术 活包膜病毒的液体疫苗 (Liquid vaccines for live enveloped viruses ) 是由 P·维尔梅吉 E·凯特斯 C·德克斯 M·皮埃斯特 于 2018-12-21 设计创作,主要内容包括:本发明描述了一种活包膜病毒和药学上可接受的载体的液体疫苗组合物,其中所述载体是天然低共熔溶剂(NADES),和所述疫苗的水活度小于约0.8。NADES在长时间和环境温度下稳定敏感病毒。在通常情况下,根据本发明的液体疫苗组合物在各种包膜病毒的不同组合物中显示出显著的稳定能力。这克服了对冻干的需求,具有巨大的经济利益。疫苗的液体性质也便于向人或动物目标施用。(The present invention describes a liquid vaccine composition of a live enveloped virus and a pharmaceutically acceptable carrier, wherein said carrier is a natural eutectic solvent (NADES), and the water activity of said vaccine is less than about 0.8. NADES stabilizes sensitive viruses over long periods of time and at ambient temperature. In general, the liquid vaccine composition according to the invention shows a significant stabilizing capacity in different compositions of various enveloped viruses. This overcomes the need for lyophilization and is of great economic interest. The liquid nature of the vaccine also facilitates administration to a human or animal subject.)

1. A liquid vaccine composition comprising a live enveloped virus and a pharmaceutically acceptable carrier, characterised in that the carrier is a natural eutectic solvent (NADES) and the water activity of the vaccine is less than 0.8.

2. The liquid vaccine composition of claim 1, wherein the NADES comprises an organic salt and a polyol.

3. The liquid vaccine composition of claim 2, wherein the organic salt is selected from the group consisting of betaine, proline, carnitine, and choline salts.

4. The liquid vaccine composition of claim 2 or 3, wherein the polyol is a sugar or sugar alcohol.

5. The liquid vaccine composition according to any one of claims 2-4, wherein the polyol is selected from the group consisting of: sucrose, glycerol, xylitol and sorbitol.

6. The liquid vaccine composition of any one of claims 1-5, wherein the water content in the composition is less than about 50% w/v.

7. The liquid vaccine composition of any one of claims 1-6, wherein the enveloped virus has an RNA genome.

8. A process for the preparation of a liquid vaccine composition according to any one of claims 1-7, said process comprising the steps of:

a. preparing the NADES, and

b. mixing the NADES with a composition comprising the live enveloped virus.

9. Use of NADES as described in any of claims 2-5 as a pharmaceutically acceptable carrier for a vaccine intended for human or animal target.

10. Use of NADES according to claim 9, wherein the vaccine is a liquid vaccine composition according to any of claims 1-7.

11. A kit comprising at least two containers: a container comprising the liquid vaccine composition according to any one of claims 1-7; and one container contains a liquid diluent.

12. The liquid vaccine composition according to any one of claims 1-7, for use in protecting a human or animal subject against infection and/or disease caused by pathogenic forms of the live enveloped virus comprised in the vaccine.

13. A method of immunizing a human or animal target, said method comprising administering a liquid vaccine composition according to any one of claims 1-7, or a vaccine obtained by the method according to claim 8, or by using a kit according to claim 11.

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