RSV immunization regimen
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.
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 subunit composition; 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, a recombinant viral vector, or a viral replication particle.
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 selecting an infant born to a female to whom an anti-RSV immune response inducing subunit composition was administered during the time when said female was pregnant with said infant and administering to said infant a nucleic acid anti-RSV immune response inducing composition encoding an RSV protein antigen.
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 claims 1 or 8 , wherein the RSV subunit composition comprises:
(a) one or more mutations that prevent cleavage at one or both of the furin cleavage sites of an RSV F protein;
(b) one or more mutations in the fusion peptide region of an RSV F protein;
(c) lack of the transmembrane region and cytoplasmic tail of an RSV F protein;
(d) one or more oligomerization sequences; and/or
(e) RSV glycoprotein in pre-fusion or post-fusion conformation.
17. The method of claims 1 or 8 , wherein the nucleic acid comprises:
(a) DNA; or
(b) RNA.
18. 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.
19. The method of claim 18 , wherein the RSV protein antigen is an RSV-F polypeptide.
20. The method of claim 8 , wherein the RSV protein antigen is an RSV-F polypeptide.