Liquid Combination Vaccine with Optimized Adjuvant Adsorption
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Solution Overview
Problem
Current combination vaccines face challenges in achieving desired levels of safety, efficacy, and immunogenicity due to inappropriate antigen formulations, leading to reactogenicity and high costs, particularly with acellular pertussis vaccines, which have short-term effectiveness and are costly, making whole-cell pertussis vaccines more suitable for developing countries.
Innovation Solution
A combination vaccine composition comprising highly purified Diphtheria and Tetanus toxoids, inactivated whole-cell Pertussis, Haemophilus influenzae type B capsular polysaccharide conjugate, and dose-reduced Inactivated Polio Virus, with optimal adjuvant and preservative use, including chemical inactivation methods to reduce reactogenicity and enhance immunogenicity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If acellular pertussis vaccines are used, then immunogenicity is improved, but cost increases and effectiveness duration decreases
Solution Approach 1:
The patent changes the formulation parameters by using whole-cell pertussis antigens instead of acellular components, and by optimizing the adjuvant system (aluminium phosphate gel) to enhance immunogenicity. This parameter change allows the use of less expensive whole-cell antigens while maintaining or improving immune response through the optimized adjuvant formulation.
2Productivity
If multiple antigens are combined in one vaccine, then number of injections is reduced, but formulation complexity increases
Solution Approach 1:
The patent merges multiple vaccine antigens (diphtheria toxoid, tetanus toxoid, whole-cell pertussis, Haemophilus influenzae type b conjugate, and inactivated polio virus) into a single liquid formulation. The antigens are individually adsorbed onto aluminium phosphate gel to ensure stability and compatibility, resolving the formulation complexity through a systematic adsorption approach.
Solution Approach 2:
The aluminium phosphate gel adjuvant system serves multiple functions simultaneously: it adsorbs and stabilizes different antigen types (protein toxoids, polysaccharide conjugates, and inactivated viruses), provides controlled release, and enhances immunogenicity across all vaccine components. This multi-functional adjuvant system simplifies the overall formulation architecture.
3Quantity of substance
If whole-cell pertussis vaccines are used, then cost is reduced, but reactogenicity increases
Solution Approach 1:
The patent extracts and removes specific harmful components from the whole-cell pertussis vaccine formulation while retaining the immunogenic whole-cell antigens. This selective extraction reduces reactogenicity while maintaining cost-effectiveness and immunogenicity.
Solution Approach 2:
The patent uses a composite adjuvant system (aluminium phosphate gel) combined with whole-cell pertussis antigens to create a formulation that mitigates the reactogenicity of whole-cell components while preserving their immunogenic properties. The composite formulation balances cost and safety.
4Stability of the object's composition
If antigens are adsorbed onto adjuvant, then stability is improved, but manufacturing complexity increases
Solution Approach 1:
The patent performs preliminary adsorption of each antigen onto the aluminium phosphate gel adjuvant during the formulation process. This preliminary action ensures stable antigen-adjuvant complexes are formed before final vaccine assembly, improving stability while using a straightforward sequential adsorption process that does not significantly increase manufacturing complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution provides a stable, immunogenic, and less reactogenic vaccine with improved potency and stability, suitable for multiple diseases, addressing the limitations of existing vaccines by enhancing immunogenicity and reducing costs.
Implementation Method 1
D and T antigens are individually adsorbed onto aluminium phosphate adjuvant
Implementation Method 2
Haemophilus influenzae type B (Hib) capsular polysaccharide antigen (PRP) conjugated to a carrier protein (CP)
Implementation Method 3
dose-reduced Salk or Sabin (Inactivated Polio Virus) IPV prepared by utilizing improved methods of formaldehyde inactivation
Implementation Method 4
The toxins are inactivated using following treatment that include Heat, UV, Formalin/Formaldehyde, glutaraldehyde, Acetylethyleneimine, etc. for making toxoids
Data Source
AI summary
An immunogenic composition comprising of Diphtheria toxoid antigen (D), tetanus toxoid (T) antigen, Hepatitis B surface antigen (HBsAg), inactivated whole-cell B. pertussis (wP) antigen, Haemophilus influenzae type B (Hib) capsular saccharide conjugated to a carrier protein, Inactivated Polio Virus (IPV) antigen and additionally one or more antigens and the method of preparing the same. A fully liquid combination vaccine, showing improved immunogenicity, reduced reactogenicity and improved stability. Improved methods of formaldehyde inactivation, improved adsorption profile of Diphtheria toxoid antigen (D), tetanus toxoid (T) antigen and Hepatitis B (HepB) surface antigen adsorbed individually onto aluminium phosphate adjuvant, minimum total aluminum content (Al3+) and optimized concentration of 2-phenoxyethanol (2-PE) as preservative.