# US 12,390,520 B2 · Vaccination in newborns and infants

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- Number: US 12,390,520 B2
- Document ID: US12390520B2
- Status: Granted
- Kind: B2
- Application number: 18/299,676
- Filed: 2023-04-12
- Published: 2023-07-27
- Granted: 2025-08-19
- Earliest claimed: 2011-03-02
- Assignees: Cure Vac SE
- Applicants: CureVac SE
- Inventors: Karl-Josef Kallen; Thomas Kramps; Margit Schnee; Benjamin Petsch; Lothar Stitz
- Web page: https://patentgrep.com/patent/US12390520B2

## CPC

- A61K 39/155: Paramyxoviridae, e.g. parainfluenza virus
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/59: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K 47/6455: {Polycationic oligopeptides, polypeptides or polyamino acids, e.g. for complexing nucleic acids}
- A61K 47/6921: {the form being a particulate, a powder, an adsorbate, a bead or a sphere}
- A61P 31/16: for influenza or rhinoviruses
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- A61K 2039/55583: {Polysaccharides}
- A61K 2039/572: {cytotoxic response}
- A61K 2039/575: {humoral response}
- A61K 2039/6031: {Proteins}
- A61K 2039/622: {non-covalent binding}
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/18534: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/18571: 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

The present invention relates to vaccines comprising at least one mRNA encoding at least one antigen for use in the treatment of a disease in newborns and/or infants, preferably exhibiting an age of not more than 2 years, preferably of not more than 1 year, more preferably of not more than 9 months or even 6 months, wherein the treatment comprises vaccination of the newborn or infant and eliciting an immune response in said newborn or infant. The present invention is furthermore directed to kits and kits of parts comprising such a vaccine and/or its components and to methods applying such a vaccine or kit.

## Claims

### Claim 1

A method for stimulating a protective antigen specific immune response in a subject comprising, administering to the subject an effective amount of a composition comprising a purified mRNA encoding a respiratory syncytial virus (RSV) fusion protein, or an antigenic fragment thereof, said mRNA comprising a 5′ cap and a poly-A sequence, wherein said mRNA is complexed with a cationic or polycationic compound, wherein the composition is administered by injection and wherein the subject is no more than 2 years of age.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is about 3 months to 2 years of age.

### Claim 3 (depends on 2)

The method of claim 2, wherein the subject is no more than 1 year of age.

### Claim 4 (depends on 3)

The method of claim 3, wherein the subject is no more than 6 months of age.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition is administered by intradermal or intramuscular injection.

### Claim 6 (depends on 5)

The method of claim 5, wherein the composition is administered by intramuscular injection.

### Claim 7 (depends on 5)

The method of claim 5, wherein the cationic or polycationic compound comprises a cationic lipid.

### Claim 8 (depends on 5)

The method of claim 5, wherein the mRNA comprises a backbone modification, a sugar modification, or a base modification.

### Claim 9 (depends on 8)

The method of claim 8, wherein the mRNA comprises a base modification.

### Claim 10 (depends on 5)

The method of claim 5, wherein the composition further comprises an adjuvant.

### Claim 11 (depends on 5)

The method of claim 5, wherein the antigen-specific immune response comprises production of antigen-specific antibodies.

### Claim 12 (depends on 11)

The method of claim 11, wherein the antigen-specific immune response comprises an antigen-specific Th1 immune response.

### Claim 13 (depends on 5)

The method of claim 5, wherein the composition further comprises a mRNA encoding at least a second viral antigen or an antigenic fragment thereof.

### Claim 14 (depends on 13)

The method of claim 13, wherein the second antigen comprises a coronavirus antigen or an influenza antigen.

### Claim 15 (depends on 14)

The method of claim 14, wherein the second antigen is an influenza hemagglutinin (HA) virus antigen, or an antigenic fragment thereof.

### Claim 16 (depends on 14)

The method of claim 14, wherein the second antigen is coronavirus spike protein, or an antigenic fragment thereof.

### Claim 17 (depends on 5)

The method of claim 5, further comprising administering at least a second dose of the composition to the subject.

### Claim 18 (depends on 17)

The method of claim 17, wherein the second dose of the composition is administered at least 10 days after the first administration.

### Claim 19 (depends on 5)

The method of claim 5, wherein the composition further comprises polyethyleneglycol.

### Claim 20 (depends on 5)

The method of claim 5, wherein the sequence of the mRNA that encodes the RSV fusion protein, or an antigenic fragment thereof, has a G/C content which is increased compared to a wild type RNA sequence encoding the RSV fusion protein or the antigen antigenic fragment thereof.

### Claim 21 (depends on 20)

The method of claim 20, wherein the G/C content which is increased by at least 15 percentage points compared to a wild type RNA sequence encoding the RSV fusion protein or the antigenic fragment thereof.

### Claim 22 (depends on 20)

The method of claim 20, wherein the G/C content which is increased by at least 20 percentage points compared to a wild type RNA sequence encoding the RSV fusion protein or the antigenic fragment thereof.

### Claim 23 (depends on 5)

The method of claim 5, wherein the mRNA comprises, from 5′ to 3′:
(i) the 5′ cap;
(ii) a 5′ untranslated region (UTR);
(iii) the sequence encoding the RSV fusion protein, or an antigenic fragment thereof;
(iv) a 3′ UTR; and
(v) the poly-A sequence.

### Claim 24 (depends on 23)

The method of claim 23, wherein the poly-A sequence is located at the 3′ terminus of the mRNA.

### Claim 25

A method for stimulating a protective antigen specific immune response in a subject comprising, administering to the subject an effective amount of a composition comprising a purified mRNA encoding a respiratory syncytial virus (RSV) fusion protein, or an antigenic fragment thereof, said mRNA comprising: a 5′ cap, a poly-A sequence and at least one base modification, said composition comprising a cationic lipid, wherein the subject is 3 months to 2 years of age and wherein the composition is administered by intramuscular injection.

### Claim 26 (depends on 25)

The method of claim 25, wherein the sequence of the mRNA that encodes the RSV fusion protein, or an antigenic fragment thereof, has a G/C content which is increased compared to a wild type RNA sequence encoding the RSV fusion protein or the antigen antigenic fragment thereof.

### Claim 27 (depends on 26)

The method of claim 26, wherein the G/C content which is increased by at least 15 percentage points compared to a wild type RNA sequence encoding the RSV fusion protein or the antigenic fragment thereof.

### Claim 28 (depends on 27)

The method of claim 27, wherein the G/C content which is increased by at least 20 percentage points compared to a wild type RNA sequence encoding the RSV fusion protein or the antigenic fragment thereof.

### Claim 29 (depends on 25)

The method of claim 25, wherein the mRNA comprises, from 5′ to 3′:
(i) the 5′ cap;
(ii) a 5′ untranslated region (UTR);
(iii) the sequence encoding the RSV fusion protein, or an antigenic fragment thereof;
(iv) a 3′ UTR; and
(v) the poly-A sequence.

### Claim 30 (depends on 29)

The method of claim 29, wherein the poly-A sequence is located at the 3′ terminus of the mRNA.

### Claim 31 (depends on 29)

The method of claim 29, wherein the RSV fusion protein is a full length RSV fusion protein.

### Claim 32 (depends on 29)

The method of claim 29, wherein the mRNA encodes an antigenic fragment of the RSV fusion protein.

### Claim 33 (depends on 29)

The method of claim 29, wherein the subject is no more than 1 year of age.

### Claim 34 (depends on 33)

The method of claim 33, wherein the subject is no more than 6 months of age.

### Claim 35 (depends on 29)

The method of claim 29, wherein the composition further comprises an adjuvant.

### Claim 36 (depends on 29)

The method of claim 29, wherein the antigen-specific immune response comprises production of antigen-specific antibodies.

### Claim 37 (depends on 29)

The method of claim 29, wherein the antigen-specific immune response comprises an antigen-specific Th1 immune response.

### Claim 38 (depends on 29)

The method of claim 29, wherein the composition further comprises a mRNA encoding at least a second viral antigen or an antigenic fragment thereof.

### Claim 39 (depends on 38)

The method of claim 38, wherein the second antigen comprises a coronavirus antigen or an influenza antigen.

### Claim 40 (depends on 39)

The method of claim 39, wherein the second antigen is an influenza hemagglutinin (HA) virus antigen, or an antigenic fragment thereof.

### Claim 41 (depends on 39)

The method of claim 39, wherein the second antigen is coronavirus spike protein, or an antigenic fragment thereof.

### Claim 42 (depends on 29)

The method of claim 29, further comprising administering at least a second dose of the composition to the subject.

### Claim 43 (depends on 42)

The method of claim 42, wherein the second dose of the composition is administered at least 10 days after the first administration.

### Claim 44 (depends on 29)

The method of claim 29, wherein the composition further comprises polyethyleneglycol.

### Claim 45 (depends on 5)

The method of claim 5, wherein the antigen-specific immune response comprises a CD8+ T cell response.

### Claim 46 (depends on 25)

The method of claim 25, wherein the antigen-specific immune response comprises a CD8+ T cell response.

### Claim 47 (depends on 29)

The method of claim 29, wherein the antigen-specific immune response comprises a CD8+ T cell response.