Patent SG-11201900365W-A (SG)
Title: Multivalent vaccine composition
Inventor: DHERE RAJEEV MHALASAKANT
IPC: A61K39/12
Filed: 2017-08-24
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication 01 March 2018 (01.03.2018) 0 0111111 100 1111 11111 11111 1111111110 11111101111 Publication Number 2018/037365 A8 CORRECTED VERSION ---_. 111111111111111111 111111111101111101 (10) International l i Date .......\"' WO W 1 PO I P CT (51) International Patent Classification: A61K 39/12 (2006.01) (21) International Application Number: (22) International Filing Date: (25) Filing Language: (26) Publication Language: (30) Priority Data: 201621029037 26 August 2016 (71) Applicants: SERUM INSTITUTE VATE LIMITED [IN/IN]; 212/2, Road, Hadapsar, Pune, Maharashtra, CENTERS FOR DISEASE CONTROL TION (CDC) [US/US]; The government States of America, as Represented by the Secretary, Depart- 24 August harashtra 411 028 (IN). KADAM, Ravindra Bapurao; Serum Institute Of India Pvt Ltd., of 212/2, Off Soli Poon- awalla Road, Hadapsar, Pune, Maharashtra. 411 028 (IN). KAMBLE, Abhijeet Sanjeev; Serum Institute Of India Pvt PCT/IB2017/055100 Ltd., of 212/2, Off Soli Poonawalla Road, Hadapsar, Pune, Maharashtra 411 028 (IN). JIANG, Baoming; The Gov- 2017 (24.08.2017) ernment of United States of America, as represented by the Secretary, Department of Health and Human Services, of English National Institutes of health Office of Technology Trans- English fer, Bethesda, Maryland 20892-7660 (US). GLASS, Roger; The Government of United States of America, as represent- ed by the Secretary, Department of Health and Human Ser- (26.08.2016) IN vices, of National Institutes of health Office of Technology OF INDIA PRI- Transfer, Bethesda, Maryland 20892-7660 (US). Off Soli Poonawalla (74) Agent: WILSON, Neeti et al.; B-41, Nizamuddin East, 411 028 (IN). THE New Delhi 110013 (IN). AND PREVEN- of the United (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, of National Institutes AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, Bethesda, Mary- CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, Serum Insti-KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, Soli Poonawalla Road, MG, MK, MN, WV MX, MY MZ, NA, NG, NI, NO, NZ, 028 (IN). PISAL, Samb- OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, India Pvt Ltd., of 212/2, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, Pune, Maharashtra TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. Serum Institute Soli Poonawalla Road, (84) Designated States (unless otherwise indicated, for every 028 (IN). SABALE, Ra- kind of regional protection available): ARIPO (BW, GH, Of India Pvt Ltd., of GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, Hadapsar, Pune, Ma- UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, ment of Health and Human Services, of Health Office of Technology Transfer, land, 20892-7660 (US). Inventors: DHERE, Rajeev Mhalasakant; (72) tute Of India Pvt Ltd., 212/2, Off of Hadapsar, Pune, Maharashtra 411 haji Shankar; Serum Institute Of Off Soli Poonawalla Road, Hadapsar, 411 028 (IN). ZADE, Jagdish Kamalaji; Of India Pvt Ltd., of 212/2, Off Hadapsar, Pune, Maharashtra 411 jendra Narayan; Serum Institute 212/2, Off Soli Poonawalla Road, (54) Title: MULTIVALENT VACCINE COMPOSITION to stable, immunogenic combination vaccine(s) comprising a mixture of antigens for pre- by Rotavirus, Poliomyelitis virus, Haemophilus influenzae, and Hepatitis B virus. The invention particularly provides a multivalent combination vaccine Salk IPV or Sabin IPV (IPV) antigens prepared by utilizing improved methods of formalde- resulting in maximum recovery of D-antigen and ii) Injectable heat inactivated Ro- (CDC-9) strains that provides a broad cross-protective immunity among human rotavirus having improved stability and immunogenicity novel conjugation process and subsequently blended at low temperature in presence of a stabi- whole ceil pertussis antigen with improved immunogenicity and stability obtained by addition stage in a blend thereby minimizing hydrolysis based Corynebacterium diphtheriae, wherein said Hib PRP -earner protein degradation v) Homogenous fractions of Gel Permeation chromatography. The dose reduced IPV. IRV antigens on hydroxide, on a combination of Alum blending is also disclosed. (57) : The present invention relates vention and prophylaxis of infections caused Clostridium tetani, Bordetella pertussis comprising of i) significantly dose reduced hyde inactivation and alum hydroxide adsorption tavirus antigen(s) obtained from Rotavirus strains, iii) Hib PRP -carrier protein conjugate conjugate is initially prepared by using GS lizer for minimizing free PRP release iv) \" 6( -4 of whole cell pertussis antigen at a later Ir) Diphtheria toxoid and Tetanus toxoid obtained M process of making such stable and immunogenic vaccine compositions by i) individually adsorbing N alum hydroxide and keeping other antigen(s) 0 en hydroxide and Alum phosphate and ii) using a particular order of addition of antigens during --.... GO Il 0 N by removal of undesirable aggregates by using unadsorbed or adsorbed on Alum Phosphate, Alum C [Continued on next page] WO 2018/037365 A8 MIDEDIM01101 DIDIRE1011111111111111111111111111101111111111111111111111111 EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) (48) Date of publication of this corrected version: 20 September 2018 (20.09.2018) (15) Information about Correction: see Notice of 20 September 2018 (20.09.2018)