Biomarkers and immunogenic compositions for filarial parasites
Inventors
Lustigman, Sara • Nutman, Thomas B. • BENNURU, Sasisekhar
Assignees
New York Blood Center Inc • US Department of Health and Human Services
Publication Number
US-12311016-B2
Publication Date
2025-05-27
Expiration Date
2037-03-31
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Abstract
Disclosed herein are immunogenic compositions for preventing or treating infection with filarial parasites and biomarkers for diagnosing infection with filarial parasites.
Core Innovation
The invention disclosed relates to immunogenic compositions for preventing or treating infection with filarial parasites, specifically targeting Onchocerca volvulus and Dirofilaria immitis, and biomarkers for diagnosing infection with these filarial parasites. The immunogenic compositions comprise filarial parasite proteins or their orthologs with specified sequence identities to a set of identified full-length mature proteins characterized by unique SEQ ID numbers.
The problem addressed is the challenge in controlling and eliminating onchocerciasis, a neglected tropical disease caused by O. volvulus, through existing mass drug administration mainly involving ivermectin, which has limitations including long duration, contraindications, and emerging resistance. There is a need for additional tools such as macrofilaricidal drugs, vaccines, and sensitive diagnostic biomarkers, which require deeper understanding of the parasite biology and host interactions.
The invention leverages stage-specific transcriptomic and proteomic analyses of O. volvulus to identify filarial parasite proteins that serve as vaccine candidates and biomarkers for infection. The immunogenic compositions may include single or multiple filarial proteins or fusion proteins thereof, optionally administered with adjuvants to induce protective or therapeutic immune responses. The biomarkers enable detection of infection by identifying filarial parasite proteins or antibodies thereto in specimens from subjects, using various immunoassay methods.
Claims Coverage
The patent discloses five independent claims focusing on methods of diagnosing infection with Onchocerca volvulus by detecting specific antibodies to a defined set of filarial proteins or fragments thereof, along with the specimen types and detection methods.
Method for detecting O. volvulus infection using antibodies to specific filarial proteins
A method comprising identifying in a specimen antibodies to O. volvulus filarial proteins Ov16 and OVOC3261, or immunoreactive fragments thereof, wherein the presence of antibodies to at least Ov16 and OVOC3261 indicates infection with O. volvulus.
Specimen types for detection of O. volvulus antibodies
The specimens comprise blood or urine samples for detecting the antibodies specific to the filarial proteins.
Use of immunoreactive fragments in detection
The immunoreactive fragments include specific amino acid sequences from OVOC10469, OVOC3261, and OVOC5127, among others, enabling detection of antibodies recognizing these epitopes.
Method enhancing detection by including additional O. volvulus proteins
A method identifying antibodies to Ov16, OVOC3261, and one or more additional filarial proteins selected from OVOC10469, OVOC5127, OVOC9988, and OVOC4230, or fragments thereof, to diagnose infection.
Method comprising antibodies to a combination of four specific proteins
Identification of antibodies to O. volvulus filarial proteins Ov16, OVOC3261, OVOC10469, and OVOC5127, or immunogenic fragments, in the specimen to confirm infection.
Detection methods for filarial protein antibodies
The use of detection techniques selected from ELISA, dipstick tests, lateral flow, microfluidic devices, luciferase immunoprecipitation systems, luminex, multiplex formats, and microarrays to identify antibodies for diagnosis.
The inventive claims protect various methods of diagnosing O. volvulus infection by detecting antibodies to a specified panel of filarial proteins or fragments, using diverse specimen types and immunoassay techniques, enhancing diagnostic sensitivity and specificity.
Stated Advantages
Immunogenic compositions based on the identified filarial proteins can induce a protective immune response against O. volvulus and D. immitis infections.
Use of combinations of proteins as biomarkers enhances the sensitivity and accuracy of diagnosing active filarial parasite infections compared to individual markers.
The immunogenic compositions can be formulated with adjuvants and administered via various routes to optimize immune protection.
The identified biomarkers and immunogenic compositions enable improved detection and prevention tools that address limitations of current mass drug administration strategies for onchocerciasis and canine heartworm.
Documented Applications
Preventing or treating infection with Onchocerca volvulus in humans using immunogenic compositions comprising specified filarial proteins or their fragments.
Preventing infection with Dirofilaria immitis in dogs using immunogenic compositions comprising specified filarial proteins or orthologs thereof.
Diagnosing infection with O. volvulus by detecting antibodies to a panel of filarial proteins in blood or urine specimens using immunoassays such as ELISA, dipstick tests, lateral flow, microfluidic devices, and microarrays.
Identifying active filarial infection through detection of filarial parasite proteins or antibodies in various specimens for epidemiological mapping, post-control surveillance, and guiding treatment strategies.
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