Freezedrying type vaccine of AIDS recombined poxvirus with Ankara gene stock carrier, and preparation method

A technology of Ankara strain and carrier vaccine, which is applied in the direction of antiviral agents, freeze-dried delivery, pharmaceutical formulations, etc., can solve the problems of no freeze-dried preparations, etc., and achieve the effects of good stability, low cost, easy production and use

Inactive Publication Date: 2007-06-20
JILIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are no reports of freeze-dried preparations for other forms of recombinant virus vector vaccines using MVA as expression vectors

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The preparation method of the freeze-dried HIV-MVA vaccine is: in 100 milliliters of phosphate solution (PB) with a pH value of 7.0 to 7.7, add 3 grams of trehalose, 2 grams of mannitol, 2 grams of dextran, and 0.8 grams of inositol gram. After fully dissolving, use a filter membrane with a pore size of 0.22um to filter and sterilize, and then inoculate the HIV recombinant MVA virus concentrate with a virus volume of 10 per person. 8 The ratio is added to the above-mentioned solution containing the freeze-drying agent for filling, and after each ampoule is divided into 0.1 ml, vacuum freeze-drying is started. The vaccine solution is pre-frozen at -35°C for 3.5 hours, and then dried in the first stage at a shelf temperature of -31°C and a vacuum of 10 Pa for 10 to 12 hours. After the product is fully formed, the temperature of the shelf is gradually raised to 28°C, and the vacuum degree is 10Pa, and then dried again for 4.5 hours. After drying, the freeze-dried HIV-MVA...

Embodiment 2

[0025] The phosphate solution (PB) in Example 1 is replaced with a phosphate physiological sodium chloride solution with a pH value of 7.0-7.7, and the effect is the same as that of Example 1.

[0026] Change the pre-freezing temperature in Example 1 to -40°C; or change the degree of vacuum to 12Pa, and the resulting product is the same as in Example 1.

[0027] The amount of trehalose and mannitol in the protective agent in Example 1 is more or less 1g in 100 ml of phosphate solution (PB), which does not affect the effect of making freeze-dried HIV-MVA vaccine.

Embodiment 3

[0029] The HIV-MVA vaccine containing the vaccine freeze-dried protective agent is divided into 0.1ml per person, and the virus content is 6.0Lg PFU ~7.0Lg PFU , a part of which was stored at 4°C to detect the infectious titer of the vaccine before freeze-drying; the other part of the vaccine was used for freeze-drying. Four different batches of HIV-MVA vaccines containing vaccine freeze-drying protective agents were freeze-dried, and then the infectious titers of the vaccines were tested and compared with the infectious titers before freeze-drying.

[0030] Table 1 Titer comparison before and after freeze-drying of the vaccine

[0031] LG PFU / ml

[0032] The detection of infectivity titer shows that the average drop in infectivity titer after freeze-drying is only 0.12 Lg compared with that before freeze-drying PFU / ml or so.

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Abstract

A freeze-dried carrier vaccine of HIV recombinant MVA virus features high stability. It is prepared from the liquid-type carrier vaccine of HIV recombinant MVA virus through adding the protecting agent prepared from mycose, mannitol, dextran and inositol, stirring and vacuum freeze drying.

Description

technical field [0001] The invention belongs to the technical field of biological products, and in particular relates to the preparation of a freeze-dried formulation vaccine using recombinant MVA virus as an expression vector. Background technique [0002] AIDS (HIV) is considered to be the first major infectious disease that directly threatens human health in the world. More than 95% of HIV infections occur in developing countries. So far, education and interventions in high-risk behaviors have only slowed the spread, not stopped it. High-efficiency antiviral therapy is expensive and too complicated for most infected people, and in addition, it cannot completely eliminate the virus from the body. In this case, only the AIDS vaccine can really effectively prevent and control AIDS. In particular, it is necessary to receive safe, highly immunogenic, and highly effective AIDS vaccines. [0003] In recent years, the study of live vector vaccines has received more and more a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/21A61K39/275A61K9/19A61P31/18
Inventor 孔维张一折姜春来吴永革于湘晖
Owner JILIN UNIV
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