HRP20210373T1 - Multivalentno pneumokokno konjugirano cjepivo - Google Patents

Multivalentno pneumokokno konjugirano cjepivo Download PDF

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HRP20210373T1
HRP20210373T1 HRP20210373TT HRP20210373T HRP20210373T1 HR P20210373 T1 HRP20210373 T1 HR P20210373T1 HR P20210373T T HRP20210373T T HR P20210373TT HR P20210373 T HRP20210373 T HR P20210373T HR P20210373 T1 HRP20210373 T1 HR P20210373T1
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serotypes
formulation
pneumococcal
serotype
pcv
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HRP20210373TT
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Matur Venkat Ramesh
Nagarajan THIRUMENI
Rajendar Burki
Dev Mantena NARENDER
Mahima DATLA
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Biological E Limited
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092Streptococcus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/6415Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
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  • Medicinal Preparation (AREA)

Claims (8)

1. Pripravak multivalentnog konjugiranog pneumokoknog cjepiva (PCV) koji se sastoji od: a1) najmanje 12 kapsularnih polisaharida odabranih između serotipova 1, 3, 4, 5, 6B, 7F, 9N, 9V, 15B, 14, 18C, 19A, 19F, 22F, 23F i 33F od S. pneumoniae aktiviranih CDAP-om i konjugiranim nosačem proteina odabranim između CRM197, pneumokoknog površinskog proteina A (PspA), pneumokoknog proteina adhezina (PsaA) ili njihove kombinacije, i izborno jednog ili više serotipova odabranih između 6C, 8, 10A, 11A, 12F, 15A, 23A, 23B i 35B od S. pneumoniae; ili a2) najmanje 14 kapsularnih polisaharida odabranih između serotipova 1, 3, 4, 5, 6B, 7F, 9N, 9V, 14, 15B, 18C, 19A, 19F, 22F, 23F i 33F od S. pneumoniae aktiviranih CDAP-om i konjugiranih do CRM197, PspA, PsaA ili njihove kombinacije, i izborno jednog ili više serotipova odabranih između 6C, 8, 10A, 11A, 12F, 15A, 23A, 23B i 35B od S. pneumoniae; i b) farmaceutski prihvatljivog nosača; i izborno farmaceutski prihvatljivog razrjeđivača ili nosača; i izborno sastojaka, pri čemu pripravak sadrži kapsularne polisaharide serotipova 22F i 33F i ne sadrži kapsularne polisaharide serotipa 6A.
2. Pripravak prema zahtjevu 1, naznačen time što količina polisaharida iz svakog od serotipova iznosi 1 do 10 µg.
3. Pripravak prema zahtjevu 1, naznačen time što količina nosača proteina konjugiranog s polisaharidom iznosi 3 do 30 µg.
4. Pripravak prema zahtjevu 1, naznačen time što pojedinačna doza od 0,5 mL sadrži 2 µg svakog polisaharida; 30-40 µg CRM197 proteina nosača; 0,2 do 1 mg adjuvanta aluminij-fosfata; natrijev klorid i pufer.
5. Formulacija 14-valentnog sterilnog tekućeg pneumokoknog konjugiranog cjepiva (PCV) koja sadrži 2 µg svakog kapsularnog polisaharida serotipova 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F i 33F, 4 µg serotipova 6B, svaki pojedinačno konjugiran na 32 µg CRM197; 0.125 mg elementarnog aluminij (0.5 mg aluminij-fosfata) adjuvanta; i pufer natrijevog klorida i L-histidina, pri čemu formulacija ne sadrži kapsularni polisaharid iz serotipa 6A.
6. Formulacija 13-valentnog sterilnog tekućeg pneumokoknog konjugiranog cjepiva (PCV) koja sadrži 2 µg svakog kapsularnog polisaharida serotipova 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F i 33F, 4 µg serotipa 6B, svaki pojedinačno konjugiran na 32 µg CRM197; 0.125 mg elementarnog aluminij (0.5 mg aluminij-fosfata) adjuvanta; i pufer natrijevog klorida i L-histidina, pri čemu formulacija ne sadrži kapsularni polisaharid iz serotipa 6A.
7. Postupak za formuliranje 13-valentne PCV formulacije prema zahtjevu 6, sadrži korake: a) konjugaciju pneumokoknih kapsularnih polisaharida poznate veličine iz serotipova 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F i 33F aktivirane pomoću CDAP-a, pojedinačno na imunogeni nosač proteina CRM197, b) diafiltraciju pojedinačnih monovalentnih pneumokoknih konjugata, nakon čega slijedi pročišćavanje pomoću kromatografije isključivanja veličine, c) analizu frakcija pomoću SEC-HPLC i udruživanje frakcija koje sadrže monovalentne pneumokokne konjugate prije sterilizacije filtra pomoću filtra od 0.2 µm, d) formulaciju 13-valentnog PCV-a pomoću 13 monovalentnih pneumokoknih konjugata; 4.4 µg za serotip 6B; 2.2 µg za ostatak serotipova i adjuvant Adju-Phos® zajedno s odgovarajućim ekscipijentom uključujući natrijev klorid i pufer koji uključuje L-histidin, praćeno aseptičnim punjenjem, naznačen time što navedena 13-valentna PCV formulacija ne sadrži kapsularni polisaharid iz serotipa 6A.
8. Postupak za formuliranje 14-valentne PCV formulacije prema zahtjevu 5 sadrži korake: a) konjugaciju pneumokoknih kapsularnih polisaharida poznate veličine iz serotipova 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F i 33F aktiviranih pomoću CDAP-a, pojedinačno na imunogeni nosač proteina CRM197, b) diafiltraciju pojedinačnih monovalentnih pneumokoknih konjugata, nakon čega slijedi pročišćavanje pomoću kromatografije isključivanja veličine, c) analizu frakcija pomoću SEC-HPLC i udruživanje frakcija koje sadrže monovalentne pneumokokne konjugate prije sterilizacije filtra pomoću filtra od 0.2 µm i d) formulaciju 14-valentnog PCV-a pomoću monovalentnih konjugata pneumokoka; 4.4 µg za serotip 6B; 2,2 µg za ostatak serotipova i adjuvant Adju-Phos®, zajedno s odgovarajućim ekscipijentom, uključujući natrijev klorid i pufer koji uključuje L-histidin, praćeno aseptičnim punjenjem, naznačen time što navedena 14-valentna PCV formulacija ne sadrži kapsularni polisaharid iz serotipa 6A.
HRP20210373TT 2015-06-23 2021-03-03 Multivalentno pneumokokno konjugirano cjepivo HRP20210373T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN3140CH2015 2015-06-23
PCT/IN2016/000157 WO2016207905A2 (en) 2015-06-23 2016-06-21 Multivalent pneumococcal conjugate vaccine
EP16753710.9A EP3313436B1 (en) 2015-06-23 2016-06-21 Multivalent pneumococcal conjugate vaccine

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EP (1) EP3313436B1 (hr)
JP (1) JP6808658B2 (hr)
CN (1) CN107810010A (hr)
AU (1) AU2016285017B2 (hr)
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LT3313436T (lt) 2021-06-10
WO2016207905A2 (en) 2016-12-29
EP3313436A2 (en) 2018-05-02
US20190240308A1 (en) 2019-08-08
WO2016207905A3 (en) 2017-02-09
PT3313436T (pt) 2021-02-25
US11147863B2 (en) 2021-10-19
DK3313436T3 (da) 2021-03-08
JP6808658B2 (ja) 2021-01-06
MX2017016828A (es) 2018-09-18
CA2989230A1 (en) 2016-12-29
SA517390539B1 (ar) 2021-05-24
PL3313436T3 (pl) 2021-06-14
CY1123838T1 (el) 2022-05-27
CN107810010A (zh) 2018-03-16
EA037373B1 (ru) 2021-03-22
EA201890431A1 (ru) 2018-06-29
AU2016285017A1 (en) 2018-01-04
JP2018518512A (ja) 2018-07-12
SI3313436T1 (sl) 2021-09-30
ZA201708713B (en) 2019-08-28
ES2857474T3 (es) 2021-09-29
RS61440B1 (sr) 2021-03-31
BR112017028130A2 (pt) 2018-08-28
HUE053272T2 (hu) 2021-06-28
EP3313436B1 (en) 2020-12-23
AU2016285017B2 (en) 2022-03-03

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