Vaccination by means of recombinant yeast by producing a protective humoral immune response against defined antigens
Inventors
Breunig, Karin • Behrens, Sven-Erik
Assignees
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Publication Number
US-11065312-B2
Publication Date
2021-07-20
Expiration Date
Abstract
The invention relates to recombinant yeasts of the Kluyveromyces lactis species for the production of a humoral immune response against defined antigens, to the production of said yeasts, and to the use thereof for protective vaccination against pathogens and malignant cells containing said antigens.
Core Innovation
The invention relates to a recombinant yeast of the species Kluyveromyces lactis that comprises a genomically integrated expression cassette with a lactose inducible LAC4 promoter, a foreign gene or a part of a foreign gene, a transcription terminator, and a GAL80 promoter (KIGAL80-P). The KIGAL80-P drives transcription of a LAC4 coding sequence, and the foreign gene is flanked by the lactose inducible LAC4 promoter and the transcription terminator, with the transcription terminator followed downstream by the KIGAL80-P.
The recombinant yeast expresses the foreign gene as a foreign protein. Subcutaneous administration of the recombinant yeast creates a protective humoral immune response.
The described platform is positioned as a recombinant Kluyveromyces lactis vaccination platform that induces a protective humoral immune response to defined antigens and enables a stable, heat-inactivated yeast subunit marker vaccine approach. In the provided supporting description, the platform is demonstrated with IBDV VP2 antigens, including specific VP2 variants, where subcutaneous administration is associated with neutralizing antibodies and protection after viral challenge.
Claims Coverage
The document provides multiple independent claims covering a recombinant K. lactis yeast product and methods for subcutaneous vaccination. The central inventive coverage repeatedly requires a genomically integrated lactose-inducible LAC4 expression cassette with downstream KIGAL80-P control, expression of a foreign protein, and creation of a protective humoral immune response after subcutaneous administration; additional independent coverage includes antibody titer determination and immunization detection.
Genomically integrated lactose inducible LAC4 expression cassette with downstream KIGAL80-P
A recombinant Kluyveromyces lactis yeast comprising a genomically integrated expression cassette comprising lactose inducible LAC4 promoter, a foreign gene or a part of a foreign gene, a transcription terminator, and GAL80 promoter (KIGAL80-P) which drives transcription of a LAC4 coding sequence, wherein the foreign gene is flanked by the lactose inducible LAC4 promoter and the transcription terminator followed downstream by the KIGAL80-P.
Foreign gene expressed as a foreign protein
The recombinant yeast wherein the foreign gene is expressed as a foreign protein.
Subcutaneous administration creates protective humoral immune response
The recombinant yeast wherein subcutaneous administration of the recombinant yeast creates a protective humoral immune response.
Subcutaneous vaccination using recombinant yeast with integrated LAC4/KIGAL80-P cassette
A method for subcutaneous vaccination by means of recombinant yeast comprising growing and proliferating the recombinant Kluyveromyces lactis, harvesting and inactivating the yeast, administering the recombinant yeast according to a predetermined subcutaneous immunization scheme, titer determination of antibodies formed by the administration and/or detection of the immunization, wherein the recombinant yeast comprises a generically integrated expression cassette comprising lactose inducible LAC4 promoter, a foreign gene or a part of a foreign gene, a transcription terminator and GAL80 promoter (KIGAL80-P) which drives transcription of a LAC4 coding sequence, and wherein the foreign gene is flanked by the lactose inducible LAC4 promoter and the transcription terminator followed downstream by the KIGAL80-P.
Antibody titer determination and immunization detection
The method wherein the administration of the recombinant yeast creates a protective humoral immune response and the method includes titer determination of antibodies formed by the administration and/or detection of the immunization.
Subcutaneous administration of vaccine with genomically integrated expression cassette
A method for subcutaneous vaccination by means of a recombinant yeast comprising subcutaneously administering a vaccine comprising a recombinant Kluyveromyces lactis, wherein the recombinant yeast comprises a genomically integrated expression cassette comprising lactose inducible LAC4 promoter, a foreign gene or a part of a foreign gene, a transcription terminator and GAL80 promoter (KIGAL80-P) which drives transcription of a LAC4 coding sequence, wherein the foreign gene is flanked by the lactose inducible LAC4 promoter and the transcription terminator followed downstream by the KIGAL80-P.
Vaccine administration creates protective humoral immune response
The method wherein the foreign gene is expressed as a foreign protein and wherein administration of the recombinant yeast creates a protective humoral immune response.
Overall, claim coverage centers on a recombinant Kluyveromyces lactis vaccination platform that uses a genomically integrated lactose inducible LAC4 expression cassette with a transcription terminator followed downstream by KIGAL80-P, expresses a foreign protein from a LAC4 coding sequence context, and relies on subcutaneous administration to create a protective humoral immune response. Method claims further cover antibody titer determination and detection of immunization during subcutaneous vaccination.
Stated Advantages
Creates a protective humoral immune response.
Protective humoral response is linked to virus challenge in the provided description.
Documented Applications
Subcutaneous vaccination to induce protective humoral immunity against defined antigens, demonstrated with IBDV VP2 and specific VP2 variants.
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