Combination vaccine composition comprising reduced dose inactivated poliovirus and method for preparing the same
Inventors
SHARMA, Inder Jit • Kumar, Rakesh • KILVANI, Jaganathan Semburakkiannan • DODDAPANENI, Manohar • SHITOLE, Anil Vyankatrao
Assignees
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Publication Number
US-12090195-B2
Publication Date
2024-09-17
Expiration Date
Abstract
The present disclosure relates to a fully liquid immunogenic composition comprising a combination of antigens/immunogens. The immunogenic composition comprises optimum amount of antigens/immunogens to confer protection against a number of diseases. The composition exhibits improved immunogenicity and stability. A process for preparing the vaccine composition is also disclosed.
Core Innovation
The document describes a fully liquid multi-dose immunogenic composition in which 0.5 ml comprises diphtheria toxoid, tetanus toxoid, inactivated whole cell pertussis, hepatitis B virus surface antigen, Haemophilus influenzae type b antigen, and inactivated polio virus antigen, combined with total aluminium adjuvant content and a defined preservative system. The composition is prepared by blending normal saline, sequential addition of defined components, pH adjustment to 6.0 to 7.0, and making up volume with remaining normal saline.
A central aspect of the disclosure is the use of aluminium salt adsorption for toxoid and HBsAg components, including percentage adsorption of at least 50% for diphtheria toxoid and at least 40% for tetanus toxoid, while maintaining total aluminium adjuvant content in defined ranges or limits. The document further specifies a preservative system based on 2-phenoxyethanol with methylparaben and/or propylparaben in defined amounts, in combination with controlled pH and aluminium adjuvant content in a fully liquid multi-dose format.
The disclosure also emphasizes defined preparation conditions for key antigens, including an inactivated whole cell pertussis antigen produced using specified Bordetella pertussis strains, formulated to be devoid of thiomersal and to provide non-clumpy, homogeneous inactivated whole-cell pertussis antigen. In addition, Hib is presented as an Hib PRP-TT conjugate, supported by defined conjugation chemistry and a quantitative constraint for free PRP, together with quantified and controlled component specifications and processing conditions to support immunogenicity and stability.
Claims Coverage
The partial content includes two independent claims: a manufacturing process claim and a fully liquid multi-dose immunogenic composition claim. The inventive coverage is built from multiple inventive features that define antigen composition and dose per 0.5 ml, adsorption and total aluminium adjuvant limits, a preservative combination, and antigen-specific preparation constraints for pertussis, Hib, and toxoid/HBsAg components, together with a defined blending and pH adjustment process.
Aluminium-adsorbed D, T, and HBsAg in a defined fully liquid multi-dose composition
The composition contains diphtheria toxoid adsorbed onto aluminium salt with percentage adsorption of at least 50%, tetanus toxoid adsorbed onto aluminium salt with percentage adsorption of at least 40%, and hepatitis B virus surface antigen adsorbed onto aluminium salt having percentage adsorption of at least 50%, with total aluminium adjuvant content in defined limits.
Defined antigen doses for wP, Hib, and type-specific IPV
The composition includes inactivated whole cell pertussis antigen containing specified Bordetella pertussis strains in a defined ratio, includes Hib antigen in a defined amount, and includes inactivated polio virus antigen with IPV Type 1, Type 2, and Type 3 amounts selected from defined ranges or specified amounts with named strains.
Non-clumpy thiomersal-free inactivated whole cell pertussis antigen
Inactivated whole cell pertussis antigen preparation is described as devoid of thiomersal such that the inactivated whole-cell pertussis antigen is non-clumpy and homogeneous, with specified inactivation and mixing conditions applied to the defined Bordetella pertussis strains.
Hib PRP-TT conjugate with low free PRP
Hib is provided as Hib PRP-TT conjugate supported by Cyanogen Bromide cyanylation chemistry with an ADH linker and a purification step, together with a quantitative constraint that the percentage of free PRP in the total purified Hib bulk conjugate is no more than 5%.
Preservative combination for multidose stability
The composition includes preservative as 2-phenoxyethanol with methylparaben and/or propylparaben in defined amounts, and in the composition claim 2-Phenoxyethanol is specified in a defined amount in 0.5 ml.
Multi-step blending and pH adjustment process to 6.0 to 7.0
The manufacturing process includes adding total normal saline to a blending vessel, sequentially adding components at specified temperatures, adding preservative, adjusting pH to 6.0 to 7.0, and adding remaining normal saline to make up volume with agitation.
Across the independent claims, the core claim coverage combines specified antigen types and quantities per 0.5 ml, aluminium adsorption and total aluminium adjuvant limits, and a defined preservative system, while also requiring antigen-specific constraints for inactivated whole-cell pertussis and for Hib PRP-TT conjugate, all executed using a defined blending and pH adjustment process.
Stated Advantages
Improved immunogenicity and stability.
Documented Applications
Used as a fully liquid multi-dose immunogenic composition containing diphtheria, tetanus, whole-cell pertussis, hepatitis B, Hib, and IPV antigens.
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