RSV immunization regimen

Patent metadata

Field	Value
Publication number	US-11452773-B2
Application number	US-201916423507-A
Country	US
Kind code	B2
Filing date	May 28, 2019
Priority date	Jan 26, 2011
Publication date	Sep 27, 2022
Grant date	Sep 27, 2022

Abstract

The invention relates to an immunization regimen whereby an infant is protected against respiratory syncytial virus (RSV) through administration of a first anti-RSV immune response inducing composition to his or her mother during pregnancy, followed by administration of a second anti-RSV immune response inducing composition to the infant after birth.

First claim

The invention claimed is:

1. A method for providing protective immunity against RSV in an infant, comprising
(a) administering a first anti-RSV immune response inducing composition to a female during pregnancy, wherein the first anti-RSV immune response inducing composition comprises an RSV nucleic acid that encodes a RSV-F protein or fragment thereof, a recombinant viral vector that encodes a RSV-F protein or fragment thereof, or a viral replication particle that encodes a RSV-F protein or fragment thereof; and
(b) administering a second anti-RSV immune response inducing composition to the infant that is born from the pregnancy, wherein the second anti-RSV immune response inducing composition comprises an RSV nucleic acid that encodes a RSV-F protein or fragment thereof, a recombinant viral vector that encodes a RSV-F protein or fragment thereof, or a viral replication particle that encodes a RSV-F protein or fragment thereof;
wherein the first anti-RSV immune response inducing composition comprises a ribonucleic acid (RNA) that encodes a RSV-F protein or fragment thereof, the second anti-RSV immune response inducing composition comprises an RNA that encodes a RSV-F protein or fragment thereof, or the first and second anti-RSV immune response inducing compositions each comprise an RNA that encodes a RSV-F protein or fragment thereof.

2. The method of claim 1 , wherein the administering in (a) boosts a neutralizing antibody response in said female.

3. The method of claim 2 , wherein the neutralizing antibody response in the female is characterized by a 2-fold or greater increase in neutralizing titer.

4. The method of claim 2 , wherein the neutralizing antibody response is complement independent.

5. The method of claim 1 , wherein administering in (a) is a prime or a boost.

6. The method of claim 1 , wherein administering in (a) is during the second or third trimester of pregnancy.

7. The method of claim 1 , wherein the administering in (b) occurs at one or more times selected from the group consisting of immediately after birth, about 2 weeks after birth, about 4 weeks after birth, about 6 weeks after birth, about 2 months after birth, about 3 months after birth, about 4 months after birth, about 6 months after birth, about 9 months after birth, and about 12 months after birth.

8. A method for protecting an infant from disease caused by RSV, comprising administering to an infant a second anti-RSV immune response inducing composition comprising an RSV nucleic acid, a recombinant viral vector, or a viral replication particle;
wherein said infant was born to a female to whom an anti-RSV immune response inducing composition comprising a first RSV nucleic acid that encodes a RSV-F protein or fragment thereof, a recombinant viral vector that encodes a RSV-F protein or fragment thereof, or a viral replication particle that encodes a RSV-F protein or fragment thereof, was administered during the time when said female was pregnant with said infant;
wherein the first anti-RSV immune response inducing composition comprises an RNA that encodes a RSV-F protein or fragment thereof, the second anti-RSV immune response inducing composition comprises an RNA that encodes a RSV-F protein or fragment thereof, or the first and second anti-RSV immune response inducing compositions each comprise an RNA that encodes a RSV-F protein or fragment thereof.

9. The method of claim 8 , wherein the anti-RSV immune response inducing composition administered to said female boosted a neutralizing antibody response in said female.

10. The method of claim 8 , wherein the boost in neutralizing antibody response is characterized by a 2-fold or greater increase in neutralizing titer.

11. The method of claim 8 , wherein the neutralizing antibody response is complement independent.

12. The method of claim 8 , wherein the anti-RSV immune response inducing composition administered to said infant is a prime or a boost.

13. The method of claim 8 , wherein the anti-RSV immune response inducing composition administered to said female was administered during the second or third trimester of pregnancy.

14. The method of claim 8 , wherein the administering to said infant occurs at one or more times selected from the group consisting of immediately after birth, about 2 weeks after birth, about 4 weeks after birth, about 6 weeks after birth, about 2 months after birth, about 3 months after birth, about 4 months after birth, about 6 months after birth, about 9 months after birth, and about 12 months after birth.

15. The method of claim 8 , wherein said anti-RSV immune response inducing composition administered to said infant is a nucleic acid, and wherein said method further comprises administering a boost of a second RSV nucleic acid composition to said infant.

16. The method of claim 1 , wherein the nucleic acid anti-RSV immune response inducing composition encoding an RSV protein antigen is a self-replicating RNA.

17. The method of claim 8 , wherein the nucleic acid anti-RSV immune response inducing composition encoding an RSV protein antigen is a self-replicating RNA.

18. The method of claim 8 , wherein the nucleic acid anti-RSV immune response inducing composition encodes an RSV F protein.

Assignees

• Glaxosmithkline Biologicals Sa

Inventors

• Dormitzer Philip

Classifications

• A61K2039/55505

  Inorganic adjuvants · CPC title

• A61K2039/55555

  Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers · CPC title

• C12N2760/18534

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

• A61K39/155 Primary

  Paramyxoviridae, e.g. parainfluenza virus · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title