Dataset Information

Thermophilic Filamentous Fungus C1-Cell-Cloned SARS-CoV-2-Spike-RBD-Subunit-Vaccine Adjuvanted with Aldydrogel^®85 Protects K18-hACE2 Mice against Lethal Virus Challenge.

ABSTRACT: SARS-CoV-2 is evolving with increased transmission, host range, pathogenicity, and virulence. The original and mutant viruses escape host innate (Interferon) immunity and adaptive (Antibody) immunity, emphasizing unmet needs for high-yield, commercial-scale manufacturing to produce inexpensive vaccines/boosters for global/equitable distribution. We developed DYAI-100A85, a SARS-CoV-2 spike receptor binding domain (RBD) subunit antigen vaccine expressed in genetically modified thermophilic filamentous fungus, Thermothelomyces heterothallica C1, and secreted at high levels into fermentation medium. The RBD-C-tag antigen strongly binds ACE2 receptors in vitro. Alhydrogel^®'85'-adjuvanted RDB-C-tag-based vaccine candidate (DYAI-100A85) demonstrates strong immunogenicity, and antiviral efficacy, including in vivo protection against lethal intranasal SARS-CoV-2 (D614G) challenge in human ACE2-transgenic mice. No loss of body weight or adverse events occurred. DYAI-100A85 also demonstrates excellent safety profile in repeat-dose GLP toxicity study. In summary, subcutaneous prime/boost DYAI-100A85 inoculation induces high titers of RBD-specific neutralizing antibodies and protection of hACE2-transgenic mice against lethal challenge with SARS-CoV-2. Given its demonstrated safety, efficacy, and low production cost, vaccine candidate DYAI-100 received regulatory approval to initiate a Phase 1 clinical trial to demonstrate its safety and efficacy in humans.

SUBMITTER: Nechooshtan R

PROVIDER: S-EPMC9783968 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Thermophilic Filamentous Fungus C1-Cell-Cloned SARS-CoV-2-Spike-RBD-Subunit-Vaccine Adjuvanted with Aldydrogel<sup>®</sup>85 Protects K18-hACE2 Mice against Lethal Virus Challenge.

Nechooshtan Ram R Ehrlich Sharon S Vitikainen Marika M Makovitzki Arik A Dor Eyal E Marcus Hadar H Hefetz Idan I Pitel Shani S Wiebe Marilyn M Huuskonen Anne A Cherry Lilach L Lupu Edith E Sapir Yehuda Y Holtzman Tzvi T Aftalion Moshe M Gur David D Tamir Hadas H Yahalom-Ronen Yfat Y Ramot Yuval Y Kronfeld Noam N Zarling David D Vallerga Anne A Tchelet Ronen R Nyska Abraham A Saloheimo Markku M Emalfarb Mark M Ophir Yakir Y

Vaccines 20221211 12

SARS-CoV-2 is evolving with increased transmission, host range, pathogenicity, and virulence. The original and mutant viruses escape host innate (Interferon) immunity and adaptive (Antibody) immunity, emphasizing unmet needs for high-yield, commercial-scale manufacturing to produce inexpensive vaccines/boosters for global/equitable distribution. We developed DYAI-100A85, a SARS-CoV-2 spike receptor binding domain (RBD) subunit antigen vaccine expressed in genetically modified thermophilic filame ...[more]

PMID: 36560529

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Dataset Information

Thermophilic Filamentous Fungus C1-Cell-Cloned SARS-CoV-2-Spike-RBD-Subunit-Vaccine Adjuvanted with Aldydrogel^®85 Protects K18-hACE2 Mice against Lethal Virus Challenge.

Publications

Thermophilic Filamentous Fungus C1-Cell-Cloned SARS-CoV-2-Spike-RBD-Subunit-Vaccine Adjuvanted with Aldydrogel<sup>®</sup>85 Protects K18-hACE2 Mice against Lethal Virus Challenge.

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Dataset Information

Thermophilic Filamentous Fungus C1-Cell-Cloned SARS-CoV-2-Spike-RBD-Subunit-Vaccine Adjuvanted with Aldydrogel®85 Protects K18-hACE2 Mice against Lethal Virus Challenge.

Publications

Thermophilic Filamentous Fungus C1-Cell-Cloned SARS-CoV-2-Spike-RBD-Subunit-Vaccine Adjuvanted with Aldydrogel<sup>®</sup>85 Protects K18-hACE2 Mice against Lethal Virus Challenge.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Thermophilic Filamentous Fungus C1-Cell-Cloned SARS-CoV-2-Spike-RBD-Subunit-Vaccine Adjuvanted with Aldydrogel^®85 Protects K18-hACE2 Mice against Lethal Virus Challenge.