Multivalent Vaccine Composition Using Segmented Stabilization

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Solution Overview

Problem

Current combination vaccines face challenges in stability and immune interference due to physical and biochemical incompatibilities between antigens, leading to reduced efficacy and increased complexity in development, especially when trying to combine multiple antigens in a single vaccine formulation.

Innovation Solution

A stable immunogenic composition is developed that includes a combination of a ribosome inactivating protein antigen and a toxin derived from bacterial spores, formulated with adjuvants like aluminum hydroxide and lyophilization techniques to enhance stability and immune response, allowing for simultaneous administration and reduced number of injections.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If multiple antigens are combined in a single vaccine formulation, then the number of injections is reduced and compliance is increased, but physical and biochemical incompatibilities between antigens cause instability and immune interference

Engineering Contradiction:
Improvenumber of injectionsVSAvoidstability of antigen combination
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The vaccine is divided into two separate injectable compositions: first composition contains the ribosome inactivating protein antigen (e.g., ricin A chain) with its stabilizing excipients, and second composition contains the bacterial spore toxin antigen (e.g., anthrax protective antigen) with its stabilizing excipients. Each composition is individually stable and can be administered separately or sequentially, avoiding direct physical and biochemical incompatibilities while still achieving multivalent immunization.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different stabilizing excipients act as intermediaries for each antigen type. The first composition uses stabilizers optimized for ribosome inactivating proteins (such as specific sugars, amino acids, or polymers), while the second composition uses stabilizers optimized for bacterial toxins (such as aluminum salts or different sugar formulations). These intermediaries protect each antigen from degradation and prevent harmful interactions between the different antigen types.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If adjuvants are added to enhance immune response, then immunogenicity is improved, but adjuvants may interact with other vaccine components and reduce overall efficacy

Engineering Contradiction:
ImproveimmunogenicityVSAvoidinteraction between components
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Adjuvants are segmented and assigned to specific antigen compositions based on compatibility and efficacy. The first composition (ribosome inactivating protein) may include adjuvants optimized for protein toxins, while the second composition (bacterial spore toxin) may include different adjuvants or adjuvant formulations. This segmentation allows each adjuvant to work effectively with its paired antigen without interfering with the other antigen-adjuvant pair, simplifying the overall system despite multiple components.

Inventive Principle:
Principle #1Segmentation

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 composition elicits a robust and durable immune response with measurable neutralizing antibodies lasting at least 200 days post-administration, providing protection against both ricin and anthrax without immune interference, thus simplifying vaccination protocols and reducing costs.

Implementation Method 1

formulated with adjuvants like aluminum hydroxide

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

lyophilization techniques to enhance stability

Methodology Applied
Scientific EffectFreeze drying: Freeze Drying

Data Source

PatentUS10293041B2Multivalent stable vaccine composition and methods of making same
Publication Date: 2019.05.21 SOLIGENIX INC
  • US10293041B2 patent drawing
  • US10293041B2 patent drawing
  • US10293041B2 patent drawing

AI summary

Stable immunogenic composition capable of eliciting a robust and durable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising at least one antigen consisting of a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores. Method making and using a stable immunogenic composition capable of eliciting a stable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising providing an immunogenic composition comprising at least one antigen comprising a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores and administering the immunogenic composition to an individual.