13-Valent Pneumococcal Conjugate Vaccine Serotype Coverage

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Solution Overview

Problem

Current pneumococcal conjugate vaccines, such as Prevnar, provide limited protection against serotypes 6A and 19A, which are significant causes of invasive pneumococcal disease and antibiotic-resistant strains, especially in infants and young children, due to inadequate immunogenic responses and reliance on serogroup cross-protection.

Innovation Solution

A 13-valent pneumococcal conjugate vaccine (13vPnC) is developed, incorporating polysaccharide-protein conjugates from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F of Streptococcus pneumoniae, conjugated to CRM 197 carrier protein, with an optional aluminum-based adjuvant, to enhance immunogenicity and provide broader coverage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a 7-valent pneumococcal conjugate vaccine is used, then coverage for serotypes 4, 6B, 9V, 14, 18C, 19F and 23F is provided, but protection against serotypes 6A and 19A is insufficient

Engineering Contradiction:
Improvevaccine coverage breadthVSAvoidprotection effectiveness
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The vaccine is divided into distinct serotype-specific components, with each polysaccharide-protein conjugate targeting a specific pneumococcal serotype. This segmentation allows the vaccine to provide targeted protection against multiple serotypes simultaneously, including the previously underrepresented 6A and 19A serotypes, thereby resolving the contradiction between coverage breadth and protection effectiveness.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The 13-valent conjugate vaccine formulation provides universal protection across multiple serotypes through a single vaccine product. By incorporating polysaccharide-protein conjugates from 13 different serotypes, the vaccine achieves multi-functionality, simultaneously protecting against both the traditional 7 serotypes and the additional 6 serotypes including 6A and 19A, thus eliminating the need for separate vaccines for different serotype groups.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If polysaccharide vaccines are used, then pneumococcal disease prevention is achieved in elderly adults and high-risk patients, but infants and young children respond poorly

Engineering Contradiction:
Improveimmunogenic responseVSAvoidage-appropriate effectiveness
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

A protein carrier (such as CRM197) is used as an intermediary to bridge the gap between polysaccharide antigens and the infant immune system. The protein carrier acts as a mediator that enhances the immunogenicity of the polysaccharide components, enabling infants and young children to mount effective immune responses against the pneumococcal serotypes, thus resolving the contradiction between reliable immunogenic response and age-appropriate effectiveness.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If serogroup cross-protection is relied upon, then decline of serotype 6A and 19A disease is expected, but a significant burden of disease will remain

Engineering Contradiction:
Improvedisease reductionVSAvoidserotype-specific protection
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The vaccine provides local quality protection by incorporating specific polysaccharide-protein conjugates for each serotype, including 6A and 19A. This serotype-specific targeting ensures that the immune response is specifically directed against these problematic serotypes, providing localized protection that goes beyond general serogroup cross-protection and resolves the contradiction between disease reduction and serotype-specific protection.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP4005595A1Multivalent pneumococcal polysaccharide-protein conjugate composition
Publication Date: 2022.06.01 WYETH LLC
  • EP4005595A1 patent drawingFigure 1
  • EP4005595A1 patent drawingFigure 2
  • EP4005595A1 patent drawingFigure 3

AI summary

An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated to a carrier protein. The immunogenic composition, formulated as a vaccine, increases coverage against pneumococcal disease in infants and young children globally, and provides coverage for serotypes 6A and 19A that is not dependent on the limitations of serogroup cross-protection.