# US 2025/0144201 A1 · Tetanus vaccine platform for embedding covid-19 vaccine

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- Number: US 2025/0144201 A1
- Document ID: US20250144201A1
- Status: Published application
- Kind: A1
- Application number: 19/017,741
- Filed: 2025-01-12
- Published: 2025-05-08
- Earliest claimed: 2020-05-30
- Assignees: Prime Bio, Inc.
- Applicants: Prime Bio, Inc.
- Inventors: Bal Ram Singh; Raj Kumar; Kruti Patel
- Web page: https://patentgrep.com/patent/US20250144201A1

## CPC

- A61K 39/08: Clostridium, e.g. Clostridium tetani
- A61K 39/215: Coronaviridae, e.g. avian infectious bronchitis virus
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/14: for RNA viruses
- A61K 2039/542: {oral/gastrointestinal}
- A61K 2039/543: {intranasal}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55544: {Bacterial toxins}
- A61K 2039/575: {humoral response}
- A61K 2039/6037: {Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]}
- C12N 2770/20022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2770/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/20071: Demonstrated in vivo effect
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A method of immunizing against COVID-19 by administering a recombinant SARS-CoV2 protein-based vaccine, developed by either embedding the epitopes/domains, or chemically attaching, to an already established vaccine candidate, e.g., a detoxified recombinant tetanus neurotoxin (DrTeNT). The developed vaccine will have three novel contributions compared to the present vaccine technology: a) providing a novel and very effective vaccine platform; b) priming with DrTeNT will prepare the host immune system for better response; and c) oral delivery of the vaccine candidate with a group of neurotoxin binding proteins (NAPs) from Clostridium sp. A Detoxified recombinant tetanus neurotoxin (DrTeNT) is prepared by mutation of the active site amino acid residues is an effective vaccine candidate, and is used for embedding epitopes of SARS-CoV-2 virus protein for vaccination against Covid-19. DrTeNT is a risk-free vaccine, free of formalin or any other chemical adjuvants.

## Claims

### Claim 1

A method of immunizing a mammal against COVID-19 by administering a protein vaccine composition comprising one or more SARS-CoV epitopes embedded in a detoxified forms of a tetanus neurotoxin (DrTeNT) sequence.

### Claim 2 (depends on 1)

The method of claim 1, wherein the vaccine composition is administered subcutaneously or intramuscularly.

### Claim 3 (depends on 1)

The method of claim 1, wherein the vaccine composition further comprises an adjuvant and/or a carrier to protect the vector from degradation.

### Claim 4 (depends on 3)

The method of claim 3, wherein the carrier is a lipid molecule or a nanocarrier comprising one or more synthetic polymers or biopolymers under a suitable pH and salt conditions for biological systems.

### Claim 5 (depends on 3)

The method of claim 3, wherein the adjuvant further comprises one or more neurotoxin associated proteins (NAPs) derived from a botulinum neurotoxin (BoNT) produced by a Clostridium botulinum.

### Claim 6 (depends on 1)

The method of claim 1, further comprising administering the vaccine composition orally, sublingually, or intranasally.

### Claim 7 (depends on 1)

The method of claim 1, wherein the protein vaccine composition comprises, a recombinant or a conjugate protein vaccine composition for treating or preventing a COVID-19 infection, comprising:
a) one or more proteins, or a variant thereof, comprising detoxified forms of a tetanus neurotoxin (DrTeNT);
b) wherein the one or more proteins, or the variant thereof, are embedded with or chemically attached to one or more epitopes and/or domains encoding a targeted immunogenic peptide derived from a Severe Acute Respiratory Syndrome (SARS-CoV2) disease or a variant thereof, to create a Tetanus COVID (TC2) recombinant protein vaccine, or a TC2 or DrTeNT conjugate protein vaccine;
c) wherein said recombinant or conjugate protein vaccine composition comprises the one or more proteins having at least 90% sequence identity to the full length of SEQ ID NOS: 3, 5, 6 or 7; and
d) wherein said recombinant or conjugate protein vaccine composition is able to activate memory cells against Severe Acute Respiratory Syndrome (SARS-CoV2) without an adverse immune response while excluding formaldehyde.