Immunogenic compositions and uses thereof
The invention relates to immunogenic compositions comprising a capsular polysaccharide (CP) from Streptococcus agalactiae , commonly referred to as group B Streptococcus (GBS), conjugated to a carrier protein, and optionally including an aluminum-based adjuvant. The invention further relates to methods for inducing an immune response in subjects against GBS and/or for reducing or preventing invasive GBS disease in subjects using the compositions disclosed herein. The resulting antibodies can be used to treat or prevent GBS infection via passive immunotherapy.
1. A method of inducing an immune response against group B Streptococcus in a human subject comprising administering to the human subject an effective amount of an immunogenic composition comprising polysaccharide-carrier protein conjugates, wherein:
(i) each of the conjugates comprises a capsular polysaccharide from a different serotype of group B Streptococcus (GBS) conjugated to a carrier protein, wherein the serotypes comprise serotypes Ia, Ib, II, III, IV, and V, wherein each conjugate has a sialic acid level of greater than 60%, and wherein the carrier protein comprises a diphtheria toxoid or CRM 197 ; and
(ii) the immunogenic composition further comprises one or more of a pharmaceutically acceptable excipient, buffer, stabilizer, adjuvant, a cryoprotectant, a salt, a divalent cation, a non-ionic detergent, an inhibitor of free radical oxidation, a carrier, or a mixture thereof;
wherein the immunogenic composition does not yield a reduced immune response to serotype III as compared to a monovalent immunogenic composition comprising a conjugate consisting of serotype III.
2. The method of claim 1 , wherein the human subject is an adult 50 years of age or older.
3. The method of claim 1 , wherein the human subject is immunocompromised.
4. The method of claim 1 , wherein the human subject has a medical condition selected from the group consisting of obesity, diabetes, HIV infection, cancer, cardiovascular disease, or liver disease.
5. The method of claim 1 , wherein the group B Streptococcus is Streptococcus agalactiae.
6. The method of claim 1 , wherein the human subject is a pregnant female.
7. The method of 6 , wherein the female is in her second half of pregnancy.
8. The method of claim 6 , wherein the pregnant female is at least at 20 weeks gestation.
9. The method of claim 6 , wherein the pregnant female is at 27 weeks to 36 weeks gestation.
10. A method of preventing or reducing a disease or condition caused by group B Streptococcus in a subject comprising administering to the subject an effective amount of an immunogenic composition comprising polysaccharide-carrier protein conjugates, wherein:
each of the conjugates comprises a capsular polysaccharide from a different serotype of group B Streptococcus (GBS) conjugated to a carrier protein, wherein the serotypes comprise serotypes Ia, Ib, II, III, IV, and V, wherein each conjugate has a sialic acid level of greater than 60%, and wherein the carrier protein comprises a diphtheria toxoid or CRM 197 ; and
(ii) the immunogenic composition further comprises one or more of a pharmaceutically acceptable excipient, buffer, stabilizer, adjuvant, a cryoprotectant, a salt, a divalent cation, a non-ionic detergent, an inhibitor of free radical oxidation, a carrier, or a mixture thereof.
11. The method of claim 10 , wherein the subject is an adult 50 years of age or older.
12. The method of claim 10 , wherein the subject is immunocompromised.
13. The method of claim 10 , wherein the subject has a medical condition selected from the group consisting of obesity, diabetes, HIV infection, cancer, cardiovascular disease, or liver disease.
14. The method of claim 10 , wherein the group B Streptococcus is Streptococcus agalactiae.
15. The method of claim 10 , wherein the subject is a pregnant female.
16. The method of 15 , wherein the female is in her second half of pregnancy.
17. The method of claim 15 , wherein the pregnant female is at least at 20 weeks gestation.
18. The method of claim 15 , wherein the pregnant female is at 27 weeks to 36 weeks gestation.