Abstract: MENINGOCOCCAL HEXAVALENT COMBINATION VACCINE The present invention relates to biopharmaceuticals. The present invention relates to combination vaccine comprising hexavalent serogroup of Neisseria meningitidis for prevention and prophylaxis of infection caused by meningococcal bacteria. The present invention relates to a hexavalent combination vaccine comprising serogroups A, B, C, Y, W, X of Neisseria meningitidis. The present invention relates to a hexavalent combination vaccine comprising polysaccharide- protein conjugate of serogroups A, C, Y, W, X and proteins of serogroup B of Neisseria meningitidis. The present invention specifically relates to a hexavalent combination vaccine comprising polysaccharide- protein conjugate of serogroup A, C, Y, W, X and mutated Factor H binding proteins (fHbp) of serogroup B of Neisseria meningitidis. The present invention further relates to the composition, use and process of preparation of hexavalent combination vaccine.
We Claim:
1. A hexavalent combination vaccine comprising (a) a combination of polysaccharidecarrier protein glycoconjugates of serogroups A, C, Y, W, and X of Neisseria
meningitidis; and (b) one or more proteins of serogroup B of N. meningitidis.
2. The hexavalent combination vaccine as claimed in claim 1, wherein the carrier protein
selected from diphtheria toxoid, CRM197, tetanus toxoid, pertussis toxoid, E. coli LT,
E. coli ST, and exotoxin A from Pseudomonas aeruginosa, Bacterial outer membrane
proteins such as, outer membrane complex c (OMPC), porins, transferrin binding
proteins, pneumolysis, pneumococcal surface protein A (PspA), or pneumococcal
adhesin protein (PsaA).
3. The hexavalent combination vaccine as claimed in claim 1, wherein the carrier protein
is individually conjugated to the polysaccharides of serogroups A, C, Y, W and X.
4. A method of preparing the polysaccharide-carrier protein glycoconjugates of
serogroups A, C, Y, W, and X of Neisseria meningitidis as claimed in anyone of claims
1-3 comprises the steps of:
a) cultivating meningitis serogroup strains A, C, Y, W and X in presence of complex
media for about 12–20 hours to produce meningococcal A, C, Y, W, and X
polysaccharides;
b) purifying the meningococcal A, C, Y, W, and X polysaccharides by processes
selected from ultrafiltration, cetyl-trimethylammonium bromide (CTAB)
precipitation, centrifugation, depth filtration, ethanol, and salt precipitation;
c) activating each of the purified meningococcal A, C, Y, W, and X polysaccharides
at an alkaline pH of 8.5–9.5 in the presence of 1-Cyano -4 Dimethylaminopyridine
Tetrafluoroborate (CDAP) and at a temperature ranging from 8-15 oC;
d) activating or derivatizing the carrier protein by 1-ethyl-3-(dimethylaminopropyl)-
carbodiimide (EDAC) for about 16–24 hours;
e) mixing and conjugating the activated A, C, Y, W, and X polysaccharides and the
activated carrier proteins to obtain the polysaccharide-carrier protein
glycoco
| # | Name | Date |
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| 1 | 202421033292-STATEMENT OF UNDERTAKING (FORM 3) [26-04-2024(online)].pdf | 2024-04-26 |
| 2 | 202421033292-PROVISIONAL SPECIFICATION [26-04-2024(online)].pdf | 2024-04-26 |
| 3 | 202421033292-POWER OF AUTHORITY [26-04-2024(online)].pdf | 2024-04-26 |
| 4 | 202421033292-FORM FOR SMALL ENTITY(FORM-28) [26-04-2024(online)].pdf | 2024-04-26 |
| 5 | 202421033292-FORM 1 [26-04-2024(online)].pdf | 2024-04-26 |
| 6 | 202421033292-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [26-04-2024(online)].pdf | 2024-04-26 |
| 7 | 202421033292-DECLARATION OF INVENTORSHIP (FORM 5) [26-04-2024(online)].pdf | 2024-04-26 |
| 8 | 202421033292-Power of Attorney [10-02-2025(online)].pdf | 2025-02-10 |
| 9 | 202421033292-FORM28 [10-02-2025(online)].pdf | 2025-02-10 |
| 10 | 202421033292-Form 1 (Submitted on date of filing) [10-02-2025(online)].pdf | 2025-02-10 |
| 11 | 202421033292-Covering Letter [10-02-2025(online)].pdf | 2025-02-10 |
| 12 | 202421033292-CERTIFIED COPIES TRANSMISSION TO IB [10-02-2025(online)].pdf | 2025-02-10 |
| 14 | 202421033292-Sequence Listing in PDF [19-02-2025(online)].pdf | 2025-02-19 |
| 15 | 202421033292-DRAWING [19-02-2025(online)].pdf | 2025-02-19 |
| 16 | 202421033292-CORRESPONDENCE-OTHERS [19-02-2025(online)].pdf | 2025-02-19 |
| 17 | 202421033292-COMPLETE SPECIFICATION [19-02-2025(online)].pdf | 2025-02-19 |
| 18 | 202421033292-FORM-9 [26-02-2025(online)].pdf | 2025-02-26 |
| 19 | 202421033292-MSME CERTIFICATE [01-03-2025(online)].pdf | 2025-03-01 |
| 20 | 202421033292-FORM28 [01-03-2025(online)].pdf | 2025-03-01 |
| 21 | 202421033292-FORM 18A [01-03-2025(online)].pdf | 2025-03-01 |
| 22 | 202421033292-FER.pdf | 2025-09-18 |
| 23 | 202421033292-OTHERS [28-10-2025(online)].pdf | 2025-10-28 |
| 24 | 202421033292-FER_SER_REPLY [28-10-2025(online)].pdf | 2025-10-28 |
| 25 | 202421033292-DRAWING [28-10-2025(online)].pdf | 2025-10-28 |
| 26 | 202421033292-COMPLETE SPECIFICATION [28-10-2025(online)].pdf | 2025-10-28 |
| 27 | 202421033292-CLAIMS [28-10-2025(online)].pdf | 2025-10-28 |
| 28 | 202421033292-PatentCertificate04-11-2025.pdf | 2025-11-04 |
| 29 | 202421033292-IntimationOfGrant04-11-2025.pdf | 2025-11-04 |
| 30 | 202421033292-FORM 8A [07-11-2025(online)].pdf | 2025-11-07 |
| 31 | 202421033292-FORM 8A [07-11-2025(online)]-1.pdf | 2025-11-07 |
| 1 | 202421033292_SearchStrategyNew_E_SEARCHE_16-09-2025.pdf |