Liquid vaccines of live enveloped viruses
A liquid vaccine, enveloped virus technology, applied in the field of vaccinology, can solve the problem of no public vaccine, no quantitative data on the long-term stability of virus infectivity, etc., to achieve the effect of saving time and cost
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Embodiment 1
[0171] Example 1: Methods and Materials
[0172] 1.1 Preparation of NADES preparation
[0173] NADES can be prepared by mixing, which can be accelerated by heating and / or adding a small amount of water. Some of the NADES samples tested and described further below in this application were prepared by dissolving organic salts and polyols in excess water. Next, excess water was removed by rotary evaporation in a 70 °C water bath for several hours at reduced atmospheric pressure. By taking into account the weight loss due to evaporation, the amount of water present in NADES can be calculated.
[0174] Other NADES samples were prepared by sonication in a water bath. Add the required amount of powder to the flask. Shake or vortex the flask briefly to mix the powder. Next, add the desired amount of water. The mixture was placed in a sonication-water bath set at 45°C and sonicated for several hours until NADES formed. During sonication, the maximum temperature can reach up t...
Embodiment 2
[0207] Example 2: Examples of NADES used in the present invention
[0208] A number of NADES formulations were prepared for use in the present invention with different compounds, different molar ratios and different water contents.
[0209] Some of the most effective NADES formulations are listed in Table 1 below; these produced clear liquid solutions that were fluid at room temperature (20-25°C). Detailed information on its composition and water content is provided. For several samples prepared, water activity was determined and the results are included. Where not indicated: the molecular weight of water is 18 Da; the trehalose used is dihydrate.
[0210] The following conclusions can be drawn:
[0211] - Choline, betaine and proline are the most versatile and effective organic acids for use in the present invention, and sorbitol, glycerol and xylitol are the most effective polyols.
[0212] - NADES can be easily prepared with water content up to 37% w / v, resulting in l...
Embodiment 3
[0218] Embodiment 3: virus stability determination result
[0219] As described above, extended stability assays were carried out for various enveloped viruses comprised in the liquid vaccine compositions according to the invention. These assays were performed at the following 3 temperatures: 4, 14 and 25°C.
[0220] Incubation for 8 weeks at 25°C can be used as an accelerated stability test, indicating the effect of incubation for 1-2 years at 4°C. Therefore, this is a very serious attack on the stability of the virus, and not all samples can be expected to survive for such a long time under these conditions.
[0221] Table 2: Stability results of BRSV and PI3 viruses
[0222]
[0223] Table 3: Stability results of CPiV
[0224]
[0225] Some conclusions from the stability results
[0226] In particular CPiV viruses were very well stabilized by the NADES 3 (stab.3) formulation; even after 8 weeks at 25°C, most of the viruses were still infectious.
[0227] Simi...
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Abstract
Description
Claims
Application Information
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