Vaccination in newborns and infants

Patent metadata

Field	Value
Publication number	US-10172935-B2
Application number	US-201715466308-A
Country	US
Kind code	B2
Filing date	Mar 22, 2017
Priority date	Mar 2, 2011
Publication date	Jan 8, 2019
Grant date	Jan 8, 2019

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.

First claim

The invention claimed is:

1. A method for stimulating an immune response in an infant subject comprising, administering an effective amount of a composition comprising a purified mRNA encoding a respiratory syncytial virus (RSV) F-protein antigen to the infant subject thereby stimulating an antigen-specific immune response in the subject, said infant subject being no more than 2 years of age, wherein the composition is administered via injection.

2. The method of claim 1 , wherein the mRNA comprises an increased G/C content relative to a wild type RNA encoding the antigen, a cap and/or a poly A tail.

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

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

5. The method of claim 1 , wherein the composition is administered parenterally.

6. The method of claim 5 , wherein the composition is administered intradermally.

7. The method of claim 1 , wherein the composition comprises the mRNA in an aqueous solution.

8. The method of claim 7 , wherein the aqueous solution is a Ringer's lactate solution.

9. The method of claim 1 , wherein at least a portion of the mRNA is complexed with a cationic or polycationic compound.

10. The method of claim 9 , wherein a portion of the mRNA is complexed with the cationic or polycationic compound and a portion of the mRNA is free from complex.

11. The method of claim 9 , wherein the cationic or polycationic compound is a polypeptide.

12. The method of claim 11 , wherein the polypeptide is protamine.

13. The method of claim 1 , wherein at least a portion of the mRNA encoding the antigen is complexed with a polymeric carrier formed by disulphide-crosslinked cationic polypeptides.

14. The method of claim 1 , further comprising administering an adjuvant to the infant subject.

15. The method of claim 14 , wherein the adjuvant is an immunostimulatory RNA (isRNA).

16. The method of claim 1 , wherein antigen-specific immune response comprises production of antigen-specific antibodies.

Assignees

• Curevac Ag

Inventors

• Kallen Karl-Josef
• Kramps Thomas
• Schnee Margit
• Petsch Benjamin
• Stitz Lothar

Classifications

• A61K2039/572

  cytotoxic response · CPC title

• A61K39/145

  Orthomyxoviridae, e.g. influenza virus · CPC title

• A61K47/6921

  the form being a particulate, a powder, an adsorbate, a bead or a sphere · CPC title

• C12N2760/16134

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• A61K2039/55

  characterised by the host/recipient, e.g. newborn with maternal antibodies · CPC title