15-Valent Pneumococcal Conjugate Vaccine Serotype Coverage

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Solution Overview

Problem

Current pneumococcal conjugate vaccines provide limited serotype coverage and immune interference issues, particularly in infants and young children, with emerging serotypes posing additional challenges.

Innovation Solution

A 15-valent pneumococcal conjugate vaccine (PCV-15) is developed, comprising polysaccharides from 15 different serotypes of Streptococcus pneumoniae conjugated to a carrier protein, specifically CRM197, with an aluminum-based adjuvant for enhanced immunogenicity, providing broad coverage against pneumococcal disease.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the number of serotypes covered by the vaccine is increased, then the serotype coverage is improved, but immune interference between serotypes occurs

Engineering Contradiction:

Improveserotype coverageVSAvoidimmune response effectiveness

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The vaccine divides the 15 serotypes into distinct polysaccharide-protein conjugate components, each targeting a specific serotype. This segmentation allows comprehensive serotype coverage while minimizing immune interference through careful formulation of individual conjugate ratios and dosing schedules.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent optimizes the concentration and ratio of each polysaccharide-protein conjugate within the multivalent formulation. By adjusting these parameters, the vaccine achieves broad serotype coverage while maintaining effective immune responses to each individual serotype, preventing immune interference.

Inventive Principle:

Principle #35Parameter changes

2Ease of manufacture

If unconjugated polysaccharides are used, then the manufacturing process is simpler, but infants and young children respond poorly to the vaccine

Engineering Contradiction:

Improvevaccine production simplicityVSAvoidimmune response in infants

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent uses a carrier protein as an intermediary to conjugate with the polysaccharide antigens. This conjugation process transforms the T-independent polysaccharide antigen into a T-dependent vaccine, enabling infants and young children to mount effective immune responses while maintaining a relatively streamlined manufacturing process.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Device complexity

If existing 7-valent or 13-valent vaccines are used, then the manufacturing complexity is reduced, but serotype coverage is insufficient against emerging serotypes

Engineering Contradiction:

Improvevaccine formulation complexityVSAvoidprotection against emerging serotypes

Core Design Contradiction:

Device complexityVSAdaptability or versatility

Solution Approach 1:

The 15-valent vaccine formulation serves multiple functions by incorporating polysaccharide-protein conjugates from 15 different serotypes, including both previously covered serotypes and emerging serotypes. This multi-functional approach provides comprehensive protection while building upon the successful platform of existing conjugate vaccines.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS8192746B215-valent pneumococcal polysaccharide-protein conjugate vaccine composition

Publication Date: 2012.06.05 MERCK SHARP & DOHME LLC

AI summary

The present invention provides a multivalent immunogenic composition having 15 distinct polysaccharide-protein conjugates. Each conjugate consists of a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F or 33F) conjugated to a carrier protein, preferably CRM197. The immunogenic composition, preferably formulated as a vaccine on an aluminum -based adjuvant, provides broad coverage against pneumococcal disease, particularly in infants and young children.