M. avium Polypeptide Diagnostic and Vaccine
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Solution Overview
Problem
Current diagnostic tests for Johne's disease caused by Mycobacterium avium subspecies paratuberculosis are inadequate, failing to detect infected animals in early stages, leading to undetected shedding and spread of the bacterium, and existing vaccines induce hypersensitivity reactions and cross-reactivity with tuberculosis antigens.
Innovation Solution
A novel protein identified from M. ptb, with a specific amino acid sequence, is used as a diagnostic marker and subunit vaccine, expressed in a heterologous host, and formulated into a recombinant polypeptide or antibody for improved detection and immunity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current diagnostic tests (culture, serology, PCR) are used to detect M. ptb infection, then detection is possible in clinical stages, but sensitivity is insufficient for preclinical detection leading to undetected shedding and spread
Solution Approach 1:
The patent extracts and isolates a specific immunogenic protein (23 kDa) from M. ptb culture filtrate to use as a diagnostic marker. This extracted protein component is then used in ELISA assays to detect antibodies in animal sera, enabling sensitive detection of preclinical infections that whole-cell tests miss.
Solution Approach 2:
The patent changes the diagnostic parameter from whole-cell antigen detection to specific protein antigen detection. By using a purified 23 kDa protein as the antigen in ELISA, the test achieves higher sensitivity and specificity for detecting anti-M. ptb antibodies in preclinically infected animals compared to traditional culture or serological methods.
2Adaptability or versatility
If whole organism vaccines (attenuated or heat-killed) are used to control Johne's disease, then vaccination coverage is achieved, but hypersensitivity reactions and cross-reactivity with tuberculosis antigens occur
Solution Approach 1:
The patent segments the whole M. ptb organism into its individual protein components, specifically identifying and isolating a 23 kDa immunogenic protein. This segmented approach allows vaccination with only the essential immunogenic component, eliminating unnecessary bacterial elements that cause hypersensitivity while maintaining protective immunity.
Solution Approach 2:
The patent extracts the specific 23 kDa immunogenic protein from the whole M. ptb organism to create a subunit vaccine. This extracted protein component provides targeted immunity without the harmful side effects associated with whole-cell vaccines, including reduced hypersensitivity reactions and decreased cross-reactivity with tuberculosis skin test antigens.
3Measurement precision
If culture methods are used to detect M. ptb, then accurate detection is achieved when organisms are present, but long incubation time is required and early stage infections are missed
Solution Approach 1:
The patent detects the host's immune response (antibodies) as a preliminary indicator of infection before significant bacterial shedding occurs. By measuring anti-M. ptb antibodies using the 23 kDa protein ELISA, infections can be identified in the preclinical stage, providing early warning before the animal becomes a shedding risk.
Solution Approach 2:
The patent uses the host's antibody response as an intermediary marker to detect M. ptb infection indirectly. Rather than waiting to culture the bacteria themselves, the test detects antibodies produced by the immune system in response to the infection, providing a faster and earlier detection method that correlates with infection status.
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 novel protein enhances the sensitivity of diagnostic tests for preclinical Johne's disease and provides a safer, more effective vaccine option that reduces hypersensitivity reactions and improves immune response without interfering with tuberculosis control programs.
Implementation Method 1
administering said polypeptide to a host in an amount sufficient to generate a protective immune response in the host
Implementation Method 2
contacting a sample with said polypeptide or a composition comprising said polypeptide and detecting a response indicative of the presence of Mycobacterium avium subspecies paratuberculosis
Data Source
AI summary
The present invention relates to an immunogenic polypeptide isolated from Mycobacterium avium subspecies paratuberculosis and variants of the polypeptide. The polypeptide and variants may be used in vaccines against Johne's disease and in methods for detection of the disease. Antibodies against the polypeptide or variants may be used in diagnostic tests for Johne's disease. Also included are polynucleotides encoding the polypeptide and variants, and methods for preparing these.