Tetravalent Dengue Vaccine Unit Dose and Administration

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Solution Overview

Problem

Current dengue vaccines, such as Dengvaxia®, are limited in their ability to provide protection against all dengue serotypes and are not safe for seronegative individuals or those under 9 years old, requiring serostatus testing and multiple doses, while also posing a risk of antibody-dependent enhancement.

Innovation Solution

A tetravalent dengue vaccine composition comprising live attenuated dengue virus strains, including chimeric serotypes, administered in a unit dose that can be given without prior serostatus testing, providing broad protection across all age groups and serostatus, including children and the elderly, and reducing the risk of severe disease.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a tetravalent dengue vaccine based on yellow fever backbone is used, then protection against all four dengue serotypes is achieved, but safety for seronegative individuals and children under 9 years old is compromised

Engineering Contradiction:
Improveprotection coverageVSAvoidsafety risk
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent segments the vaccination strategy by age group and serostatus. Children under 9 receive a different vaccine formulation (live attenuated dengue vaccine without yellow fever backbone) compared to individuals 9 years and older (tetravalent vaccine). This segmentation eliminates the safety risk for children and seronegative individuals while maintaining protection coverage for appropriate populations.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent changes key parameters of the vaccine formulation based on the target population. For children under 9 and seronegative individuals, it uses a live attenuated dengue vaccine with reduced viral load and without yellow fever backbone. For individuals 9 years and older, it employs the full tetravalent formulation. This parameter change resolves the contradiction by optimizing safety and efficacy for each population segment.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If serostatus testing is required before vaccination, then safety for seronegative individuals is improved, but vaccination complexity and time consumption increase

Engineering Contradiction:
ImprovesafetyVSAvoidvaccination procedure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent segments the population into distinct groups (children under 9, individuals 9 years and older) with different vaccination protocols. This segmentation allows seronegative individuals and children to receive a safe vaccine formulation without requiring serostatus testing, thereby maintaining safety while eliminating the complexity of testing procedures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent creates a universal vaccination strategy where a single vaccine formulation (live attenuated dengue vaccine) can be safely administered to all children under 9 and seronegative individuals regardless of serostatus. This multi-functional approach eliminates the need for serostatus testing while ensuring safety across the entire target population.

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

3Reliability

If multiple vaccine doses are administered, then immune response efficacy is improved, but vaccination time and resource requirements increase

Engineering Contradiction:
Improveimmune responseVSAvoidvaccination schedule
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent optimizes the dosage parameters based on age group and serostatus. Seropositive individuals receive a reduced dose (0.5 mL) compared to seronegative individuals (1.0 mL), and children under 9 receive appropriately adjusted dosing. This parameter optimization maintains immune response efficacy while reducing the total vaccination time and resource requirements compared to universal full-dose scheduling.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20230355748A1Dengue vaccine unit dose and administration thereof
Publication Date: 2023.11.09 TAKEDA VACCINES INC
  • US20230355748A1 patent drawing
  • US20230355748A1 patent drawing
  • US20230355748A1 patent drawing

AI summary

The invention relates to a single unit dose of a dengue vaccine composition and methods and uses for preventing dengue disease and methods for stimulating an immune response to all four dengue virus serotypes in a subject or subject population. The unit dose of a dengue vaccine composition includes constructs of each dengue serotype, such as TDV-1, TDV-2, TDV-3 and TDV-4, at various concentrations in order to improve protection from dengue infection.