Combination Vaccine with Reduced Antigen and Adjuvant Doses

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Solution Overview

Problem

Current combination vaccines often contain high levels of aluminium salts and antigens, which raise concerns for patient safety and compliance, and may not be optimized for reduced doses without compromising immunoprotective effects.

Innovation Solution

Development of combination vaccine compositions with reduced amounts of aluminium and antigens, including aluminium-free options, using oil-in-water emulsion adjuvants and adsorbed TLR agonists to maintain immunogenicity and immunoprotective effects, while allowing for fewer doses in infant immunization schedules.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high amounts of aluminium salts are used as adjuvants in combination vaccines, then immunogenicity is improved, but patient safety concerns increase

Engineering Contradiction:
ImproveimmunogenicityVSAvoidpatient safety concerns
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by systematically reducing the aluminium content from conventional levels (0.3-0.85 mg Al+++ per unit dose) to lower levels (0.03-0.2 mg Al+++ per unit dose), and ultimately to aluminium-free formulations. This parameter transformation maintains immunogenicity through optimized antigen combinations and dosing strategies while eliminating safety concerns associated with high aluminium exposure

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent extracts and removes aluminium salts from the vaccine formulation entirely in certain embodiments, creating aluminium-free combination vaccines. This extraction eliminates the harmful adjuvant while preserving immunogenicity through alternative formulation strategies, directly resolving the contradiction between adjuvant efficacy and patient safety

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If high amounts of antigen are used in combination vaccines, then immunoprotective effect is improved, but vaccine complexity and dosage requirements increase

Engineering Contradiction:
Improveimmunoprotective effectVSAvoidvaccine complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies partial action by using reduced amounts of each individual antigen component in the combination vaccine. Rather than including full doses of multiple antigens that would create complexity, the formulation uses optimized lower doses of each antigen (e.g., reduced diphtheria, tetanus, pertussis, Hib, polio, and hepatitis B components) that collectively provide adequate immunoprotective effect while simplifying the overall vaccine composition

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The patent merges multiple antigen components into a single integrated combination vaccine formulation. By combining reduced doses of six different antigens (diphtheria, tetanus, pertussis, Hib, polio, and hepatitis B) into one cohesive product, the patent reduces the number of separate injections required, simplifying the vaccination schedule and improving compliance while maintaining comprehensive immunoprotective coverage

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If multiple injections are required for pediatric vaccination, then adequate immunization coverage is achieved, but patient compliance decreases

Engineering Contradiction:
Improveimmunization coverageVSAvoidpatient compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent merges six separate vaccine components into a single combination vaccine formulation, reducing the number of injections from six separate shots to one integrated injection. This merging maintains comprehensive immunization coverage against diphtheria, tetanus, pertussis, Hib, polio, and hepatitis B while dramatically improving patient compliance by eliminating repeated needle sticks

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a multi-functional vaccine that simultaneously provides protection against six different pathogens through a single administration. This universal approach allows one vaccine formulation to perform multiple immunization functions, achieving broad immunization coverage while simplifying the vaccination process and improving ease of operation for pediatric patients

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

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 achieves comparable immunogenicity and immunoprotective effects with lower aluminium and antigen doses, enhancing patient safety and compliance, and reduces the number of doses required in infant immunization schedules without compromising efficacy.

Implementation Method 1

an aluminium salt adjuvant

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

oil-in-water emulsion adjuvant

Methodology Applied
Scientific EffectEmulsion: Emulsion

Data Source

PatentUS10603369B2Combination vaccines with lower doses of antigen and/or adjuvant
Publication Date: 2020.03.31 GLAXOSMITHKLINE BIOLOGICALS SA
  • US10603369B2 patent drawing
  • US10603369B2 patent drawing
  • US10603369B2 patent drawing

AI summary

Combination vaccine compositions as well as methods for their manufacture have a relatively low amount of antigen and/or a relatively low amount of aluminium, but they can nevertheless have immunogenicity which is comparable to combination vaccines with a relatively high amount of antigen and/or a relatively high amount of aluminium. Aluminium-free combination vaccine compositions are also provided e.g. compositions which are adjuvanted with an oil-in-water emulsion adjuvant.