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Temperature stable vaccine formulations

A stable and vaccine technology, applied in the field of freeze-dried and frozen vaccine preparations, can solve problems such as loss of potency

Inactive Publication Date: 2015-03-25
EMERGENT PROD DEV GAITHERSBURG INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these newer technologies are still in their infancy and are yet to be used in the United States to create licensed vaccines
[0014] Freezing of alum-containing vaccine compositions (either as part of the lyophilization process or to manufacture frozen vaccines) often induces aggregation of aluminum particles and causes degradation of antigens adsorbed to alum adjuvants, resulting in loss of potency

Method used

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  • Temperature stable vaccine formulations
  • Temperature stable vaccine formulations
  • Temperature stable vaccine formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0115] Example 1: Freezing / thawing of liquid rPA and AVA vaccines with and without trehalose

[0116] rPA102 vaccine formulations were prepared with and without trehalose as outlined in Table 1 below.

[0117] Table 1. Trehalose Preparations Used for Freeze / Thaw Analysis

[0118]

[0119] After compounding, each sample was divided into two 8ml aliquots in 10ml glass tubes. For each sample, one tube was placed at -80°C after gentle mixing overnight and the other tube was placed at 2-8°C after gentle mixing overnight.

[0120] Samples stored overnight at -80°C were thawed on the lab bench for several hours (>3-4 hours) the next day, then observed and compared to samples brought to room temperature at 2-8°C. Photograph the samples and measure the total liquid height and ALHYDROGEL (aluminum hydroxide) height. Comparison of conventional rPA102 vaccine before and after freezing / thawing. figure 1 are photographs comparing rPA Control 1 samples at 2-8°C (labeled ...

Embodiment 2

[0125] Example 2: Freezing / thawing of liquid rPA vaccines with and without sucrose

[0126] The rPA102 vaccine formulations were prepared with and without sucrose as outlined in Table 3 below.

[0127] Table 3. Sucrose preparations used for freeze / thaw analysis

[0128]

[0129] After compounding, each sample was divided into two 10ml aliquots in 10ml glass tubes. For each sample, one tube was placed at -80°C after gentle mixing overnight and the other tube was placed at 2-8°C after gentle mixing overnight.

[0130] Samples stored overnight at -80°C were thawed on the laboratory bench for 2-3 hours the next day before observation. image 3 Contains photographs of each formulation from 2-8°C (marked 5°C) and -80°C after both had reached room temperature. As shown, after thawing, gel collapse occurred in both -80°C samples (rPA Control 2 and rPA Test 2) compared to samples still refrigerated at 2-8°C. However, the amount of gel collapse was significantly gre...

Embodiment 3

[0131] Example 3: In Vivo Mouse Potency Analysis

[0132] Lyophilized vaccines were prepared as outlined in Table 4. The dried vaccine was reconstituted with water for injection to a final rPA concentration of 0.15 mg / ml (75 μg / 0.5 ml dose), followed by 10-fold dilution in saline to obtain a dose level of 0.1 (DL).

[0133] Female CD-1 mice, 5-8 weeks old and weighing 20-25 grams, were each used in this study. 0.1 DL vaccine (0.5 ml) was injected intraperitoneally into groups of 20 female CD-1 mice, and serum was collected on day 28 to assess neutralization of anthrax LT cells in mice in a toxin neutralization assay (TNA) The ability to be toxic.

[0134] Table 4. Lyophilized formulations used for mouse potency assays

[0135]

[0136] The immunogenicity of the rPA102 preparation was studied by calculating the neutralization factor (NF50). Neutralization factor NF50 is defined as follows:

[0137]

[0138] wherein the effective dose 50% (ED50) refer...

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Abstract

Formulations of vaccine antigen, such as anthrax protective antigen, are provided that are stable after undergoing freeze and thaw conditions. Methods of using the formulations to prepare vaccine are also provided. Vaccines comprising the formulations are useful, for example, to protect against, inhibit or alleviate a disease or infection, such as related to anthrax infection.

Description

[0001] government rights [0002] This invention was made in part with Government support under Grant HHSO100201000059C. The government may have certain rights in this invention. [0003] References to Sequence Listings Submitted Electronically [0004] The contents of the sequence listing in ASCII text file (name "2479115PC02_sequencelisting.txt"; size: 12,954 bytes; and creation date: June 25, 2013) filed electronically with this application are incorporated by reference incorporated herein in its entirety. field of invention [0005] The present invention relates to temperature stable vaccine formulations containing antigens adsorbed to aluminum adjuvants and methods of preparing these formulations. The invention includes lyophilized and frozen vaccine formulations. The invention includes temperature stable vaccines, methods of making temperature stable vaccines and methods of using them. Background of the invention [0006] Anthrax is a well-known infectious disease...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/18
CPCA61K47/24A61K47/26A61K9/19A61K39/39A61K39/07A61K2039/55505A61P31/04A61K47/183A61K2039/555A61K47/02
Inventor J·卢克C·F·鲁伊斯A·P·麦尔斯R·W·韦尔奇
Owner EMERGENT PROD DEV GAITHERSBURG INC
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