Mucosal vaccine formulations

A technology of formulations, bioadhesives, applied in the field of formulations for mucosal application, capable of solving problems such as retention difficulties

Pending Publication Date: 2022-01-21
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Retention is difficult and requires considerable effort to keep the vaccine in contact with the epithelium

Method used

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  • Mucosal vaccine formulations
  • Mucosal vaccine formulations
  • Mucosal vaccine formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Example 1: In vitro stability of adenovirus in bioadhesive formulations

[0135] The stability of bioadhesive formulations of adenovirus at 4°C and 37°C and after freeze-thaw was tested in vitro. Stability was measured by qualitative PCR (qPCR) and with an infectivity assay detecting the adenovirus hexon protein in cultured cells. The effect of bioadhesive agents on adenovirus stability was evaluated using a genetically modified replication-deficient ChAd155 vector (ChAd155-RGco2) with deleted E1 / E4 gene regions and expressing codon-pair optimized rabies glycoprotein (G) (WO2018 / 104919).

[0136] Degradation of ChAd155 virions in various storage media was evaluated experimentally by measuring the infectivity of virus preparations over time at a controlled storage temperature of 4°C. Infectivity was determined in HEK293 cells using a hexon ELISA assay that measures the expression of viral hexon proteins following infection of cells. Stability is expressed as the ab...

Embodiment 2

[0140] Example 2: In vivo immunogenicity of adenovirus in bioadhesive formulations

[0141] To determine the effect of bioadhesives on the immunogenicity of adenovirus, 1x10 9 vp ChAd155-RGco2 was formulated in Formulation 2, Formulation 2 with 1.5% CMC or Formulation 2 with 20% Poloxamer 407. 7ul was delivered sublingually to each of six Balb / c mice. As a control, with 1x10 in formulation 2 9 A group of mice were immunized intramuscularly with vp ChAd155-RGco2. Anti-rabies virus neutralizing antibody (VNA) titers in sera were determined by fluorescent antibody virus neutralization (FAVN) test at 4, 6 and 8 weeks after vaccination.

[0142] Such as figure 2 As shown in , anti-rabies VNA titers were comparable among the three sublingually immunized groups, indicating that the presence of CMC or Poloxamer 407 in the formulation had no negative effect on the immune potency of the rabies vaccine. All sublingually immunized mice had titers well above the seroconversion thre...

Embodiment 3

[0143] Example 3. Effect of known mucosal adjuvants on the immunogenicity of simian adenovirus

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Abstract

Simian adenoviral vectors are formulated with bioadhesives and excipients that maintain immunogenicity. They can be administered mucosally to provide effective prophylaxis and therapy.

Description

[0001] field of invention [0002] The present invention is in the field of prevention and treatment of disease. In particular, the invention relates to formulations suitable for mucosal administration of simian adenovirus vaccines. [0003] Background of the invention [0004] Adenoviral vectors have been demonstrated to provide prophylactic and therapeutic delivery platforms whereby nucleic acid sequences encoding therapeutic molecules are incorporated into the adenoviral genome and expressed upon administration of the adenoviral particles to a treated subject. Most people are exposed to and develop immunity to human adenoviruses. Accordingly, there is a need for vectors that efficiently deliver prophylactic or therapeutic molecules to human subjects while minimizing the impact of pre-existing immunity to human adenovirus serotypes. Simian adenoviruses are effective in this regard because humans have little or no pre-existing immunity to simian viruses, but these viruses ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00A61K39/39A61K39/155A61K47/10A61K47/26A61K47/32A61K47/36A61K47/38A61P31/14
CPCA61K39/00A61K39/39A61K39/12A61K47/26A61K47/10A61K47/32A61K47/38A61K47/36A61P31/14A61K2039/541A61K2039/5256A61K2039/55527C12N2760/18534A61K9/006A61K9/08
Inventor S.加洛里尼F.纳波里塔诺A.维特利
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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