Immunogenic Compositions Comprising Conjugated Capsular Saccharide Antigens and Uses Thereof

• US 20150202309A1
• Filed: 01/15/2015
• Published: 07/23/2015
• Est. Priority Date: 01/21/2014
• Status: Active Grant

• Current Assignee: Pfizer Inc.
• Original Assignee: Pfizer Inc.
• Inventors: Han, Mingming, Jansen, Kathrin Ute, Emini, Emilio Anthony, Watson, Wendy Jo, Prasad, Avvari Krishna, Kim, Jin-Hwan, Gu, Jianxin, Yang, Yu-ying, Kainthan, Rajesh Kumar, Cooper, David, Pride, Michael William
• Granted Patent: US 9,492,559 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/6037 Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/092 Streptococcus
• CPC Class Codes: A61K 47/646 the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: 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

Abstract

The present invention relates to new immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (glycoconjugates) and uses thereof. Immunogenic compositions of the present invention will typically comprise at least one glycoconjugate from a S. pneumoniae serotype not found in PREVNAR®, SYNFLORIX® and/or PREVNAR 13®. The invention also relates to vaccination of human subjects, in particular infants and elderly, against pneumoccocal infections using said novel immunogenic compositions.

Claims

1. An immunogenic composition comprising at least one glycoconjugate selected from the group consisting of a glycoconjugate from S. pneumoniae serotype 15B, a glycoconjugate from S. pneumoniae serotype 22F, a glycoconjugate from S. pneumoniae serotype 33F, a glycoconjugate from S. pneumoniae serotype 12F, a glycoconjugate from S. pneumoniae serotype 10A, a glycoconjugate from S. pneumoniae serotype 11A and a glycoconjugate from S. pneumoniae serotype 8.

2. The immunogenic composition of claim 1 comprising at least one glycoconjugate from S. pneumoniae serotype 15B.

3. The immunogenic composition of claim 1 comprising at least one glycoconjugate from S. pneumoniae serotype 22F.

4. The immunogenic composition of claim 1 comprising at least one glycoconjugate from S. pneumoniae serotype 33F.

5. The immunogenic composition of claim 1 comprising at least one glycoconjugate from S. pneumoniae serotype 12F.

6. The immunogenic composition of claim 1 comprising at least one glycoconjugate from S. pneumoniae serotype 10A.

7. The immunogenic composition of claim 1 comprising at least one glycoconjugate from S. pneumoniae serotype 11A.

8. The immunogenic composition of claim 1 comprising at least one glycoconjugate from S. pneumoniae serotype 8.

18. The immunogenic composition of claim 1 further comprising glycoconjugates from S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.

19. The immunogenic composition of claim 1 further comprising glycoconjugates from S. pneumoniae serotypes 1, 5 and 7F.

20. The immunogenic composition of claim 1 further comprising glycoconjugates from S. pneumoniae serotypes 6A and 19A.

21. The immunogenic composition of claim 1 further comprising at least one glycoconjugate from S. pneumoniae serotype 3.

22. The immunogenic composition of claim 1, wherein the immunogenic composition is an 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20-valent pneumococcal conjugate composition.

27. The immunogenic composition of claim 1, wherein said glycoconjugates are individually conjugated to CRM197.

135. The immunogenic composition of claim 1, wherein each dose of said immunogenic composition comprises 0.1 to 100 μ

g of polysaccharide of the at least one glycoconjugate.

139. The immunogenic composition of claim 1, wherein each dose of said immunogenic composition comprises 10 μ

g to 150 μ

g of carrier protein of the at least one glycoconjugate.

140. The immunogenic composition of claim 139, wherein said carrier protein is CRM197.

142. The immunogenic composition of claim 1, wherein said immunogenic composition further comprise antigens comprises an antigen from other pathogens.

143. The immunogenic composition of claim 142, wherein said antigen is selected from the group consisting of a diphtheria toxoid (D), a tetanus toxoid (T), a pertussis antigen (P), an acellular pertussis antigen (Pa), a hepatitis B virus (HBV) surface antigen (HBsAg), a hepatitis A virus (HAV) antigen, a conjugated Haemophilus influenzae type b capsular saccharide (Hib), and an inactivated poliovirus vaccine (IPV) antigen.

157. The immunogenic composition of claim 1, wherein said immunogenic composition further comprises a conjugated N. meningitidis serogroup A capsular saccharide (MenA), a conjugated N. meningitidis serogroup W135 capsular saccharide (MenW135), a conjugated N. meningitidis serogroup Y capsular saccharide (MenY), or a conjugated N. meningitidis serogroup C capsular saccharide (MenC).

158. The immunogenic composition of claim 1, wherein said immunogenic composition further comprise at least one adjuvant.

159. The immunogenic composition of claim 158, wherein said at least one adjuvant is selected from the group consisting of aluminum, calcium phosphate, a liposome, an oil-in-water emulsion, and poly(D,L-lactide-co-glycolide) (PLG) microparticles or nanoparticles.

160. The immunogenic composition of claim 159, wherein said adjuvant is an aluminum adjuvant selected from the group consisting of aluminum phosphate, aluminum sulfate and aluminum hydroxide.

167. The immunogenic composition of claim 158, wherein said at least one adjuvant is a CpG Oligonucleotide.

168. The immunogenic composition of claim 1, wherein said immunogenic composition is formulated in liquid form.

169. The immunogenic composition of claim 1, wherein said immunogenic composition is formulated in a lyophilized form.

171. The immunogenic composition of claim 1, wherein said immunogenic composition further comprises a buffer, a salt, a divalent cation, a non-ionic detergent, a cryoprotectant, an anti-oxidant, or a combination thereof.

192. A container filled with the immunogenic composition of claim 1.

197. A syringe filled with the immunogenic composition of claim 1.

208. A method of preventing, treating or ameliorating an infection, disease or condition associated with S. pneumoniae in a subject comprising administering to the subject an effective amount of the immunogenic composition of claim 1.

209. A method of preventing an infection caused by S. pneumoniae in a subject comprising administering to the subject an effective amount of the immunogenic composition of claim 1.

211. The method of claim 208, wherein the subject is a human being less than 2 years of age.

212. The method of claim 208, wherein the subject is a human adult 50 years of age or older.

213. The method of claim 208, wherein the subject is an immunocompromised human.

214. The method of claim 208, wherein the immunogenic composition is administered in a single dose schedule.

215. The method of claim 208, wherein the immunogenic composition is administered in a multiple dose schedule.

281. A method of inducing an immune response to S. pneumoniae serotype 15A, 15B or 15C in a subject comprising the step of administering an effective amount of the immunogenic composition of claim 2.

282. A method of inducing an immune response to S. pneumoniae serotype 22F in a subject comprising the step of administering an effective amount of the immunogenic composition of claim 3.

283. A method of inducing an immune response to S. pneumoniae serotype 33F in a subject comprising the step of administering an effective amount of the immunogenic composition of claim 4.

284. A method of inducing an immune response to S. pneumoniae serotype 12F in a subject comprising the step of administering an effective amount of the immunogenic composition of claim 5.

285. A method of inducing an immune response to S. pneumoniae serotype 10A in a subject comprising the step of administering an effective amount of the immunogenic composition of claim 6.

286. A method of inducing an immune response to S. pneumoniae serotype 11A in a subject comprising the step of administering an effective amount of the immunogenic composition of claim 7.

287. A method of inducing an immune response to S. pneumoniae serotype 8 in a subject comprising the step of administering an effective amount of the immunogenic composition of claim 8.

9. An immunogenic composition comprising at least one glycoconjugate from S. pneumoniae serotype 15B, at least one glycoconjugate from S. pneumoniae serotype 22F and at least one glycoconjugate from S. pneumoniae serotype 33F.

10. An immunogenic composition comprising at least one glycoconjugate from S. pneumoniae serotype 15B, at least one glycoconjugate from S. pneumoniae serotype 22F, at least one glycoconjugate from S. pneumoniae serotype 33F, at least one glycoconjugate from S. pneumoniae serotype 12F, at least one glycoconjugate from S. pneumoniae serotype 10A, at least one glycoconjugate from S. pneumoniae serotype 11A and at least one glycoconjugate from S. pneumoniae serotype 8.

11-17. -17. (canceled)

23-26. -26. (canceled)

28-134. -134. (canceled)

136-138. -138. (canceled)

141. (canceled)

144-156. -156. (canceled)

161-166. -166. (canceled)

170. (canceled)

172-191. -191. (canceled)

193-196. -196. (canceled)

198-207. -207. (canceled)

210. (canceled)

216-280. -280. (canceled)