[go: up one dir, main page]
More Web Proxy on the site http://driver.im/

WO2001030390A3 - Method - Google Patents

Method Download PDF

Info

Publication number
WO2001030390A3
WO2001030390A3 PCT/EP2000/010733 EP0010733W WO0130390A3 WO 2001030390 A3 WO2001030390 A3 WO 2001030390A3 EP 0010733 W EP0010733 W EP 0010733W WO 0130390 A3 WO0130390 A3 WO 0130390A3
Authority
WO
WIPO (PCT)
Prior art keywords
vaccine
response
animal
immune response
dose
Prior art date
Application number
PCT/EP2000/010733
Other languages
French (fr)
Other versions
WO2001030390A2 (en
Inventor
Craig Antony Joseph Laferriere
Jan Poolman
Moncef Mohamed Slaoui
Original Assignee
Smithkline Beecham Biolog
Craig Antony Joseph Laferriere
Jan Poolman
Moncef Mohamed Slaoui
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smithkline Beecham Biolog, Craig Antony Joseph Laferriere, Jan Poolman, Moncef Mohamed Slaoui filed Critical Smithkline Beecham Biolog
Priority to CA002388995A priority Critical patent/CA2388995A1/en
Priority to EP00981226A priority patent/EP1223987A2/en
Priority to AU18549/01A priority patent/AU1854901A/en
Priority to JP2001532807A priority patent/JP2003512440A/en
Publication of WO2001030390A2 publication Critical patent/WO2001030390A2/en
Publication of WO2001030390A3 publication Critical patent/WO2001030390A3/en

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5082—Supracellular entities, e.g. tissue, organisms
    • G01N33/5088—Supracellular entities, e.g. tissue, organisms of vertebrates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/62—Medicinal 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
    • A61K47/64—Drug-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
    • A61K47/646—Drug-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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6068—Other bacterial proteins, e.g. OMP
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2400/00—Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
    • G01N2400/10—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Virology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Communicable Diseases (AREA)
  • Biotechnology (AREA)
  • Toxicology (AREA)
  • Oncology (AREA)
  • Mycology (AREA)
  • Pulmonology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to the field of methods of testing a vaccine response in an animal model to obtain information on the response of humans to the same vaccinogen. The present invention provides a method of determining the dose response of a human to a polysaccharide conjugate vaccine comprising an immunogenic carrier protein and a bacterial polysaccharide, said method comprising the steps of administering to an infant animal a dose amount of said conjugated vaccine, and determining the immune response of the animal to the bacterial polysaccharide as a measure of the immune response of a human. Preferred, modes of administration of vaccine in the model, dose of vaccine tested, time between doses, time of serum harvesting, method of determination of immune response, and type (and age) of infant animal used are also all provided.
PCT/EP2000/010733 1999-10-28 2000-10-27 Method WO2001030390A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA002388995A CA2388995A1 (en) 1999-10-28 2000-10-27 Method
EP00981226A EP1223987A2 (en) 1999-10-28 2000-10-27 Method
AU18549/01A AU1854901A (en) 1999-10-28 2000-10-27 Novel method
JP2001532807A JP2003512440A (en) 1999-10-28 2000-10-27 New method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9925559.8 1999-10-28
GBGB9925559.8A GB9925559D0 (en) 1999-10-28 1999-10-28 Novel method

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US10111521 A-371-Of-International 2002-08-02
US10/818,819 Continuation US20040191834A1 (en) 1999-10-28 2004-04-06 Novel method

Publications (2)

Publication Number Publication Date
WO2001030390A2 WO2001030390A2 (en) 2001-05-03
WO2001030390A3 true WO2001030390A3 (en) 2002-04-04

Family

ID=10863574

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2000/010733 WO2001030390A2 (en) 1999-10-28 2000-10-27 Method

Country Status (6)

Country Link
EP (1) EP1223987A2 (en)
JP (1) JP2003512440A (en)
AU (1) AU1854901A (en)
CA (1) CA2388995A1 (en)
GB (1) GB9925559D0 (en)
WO (1) WO2001030390A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9358279B2 (en) 2005-06-27 2016-06-07 Glaxosmithkline Biologicals S.A. Immunogenic composition

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
OA12302A (en) 2000-06-29 2003-10-24 Glaxosmithkline Biolog Sa Multivalent vaccine composition.
GEP20053691B (en) 2001-01-23 2005-12-12 Pasteur Multivalent Meningococcal Polysaccharide-Protein Conjugate Vaccine
GB0115176D0 (en) 2001-06-20 2001-08-15 Chiron Spa Capular polysaccharide solubilisation and combination vaccines
GB0211118D0 (en) * 2002-05-15 2002-06-26 Polonelli Luciano Vaccines
NZ562998A (en) 2002-10-11 2008-05-30 Novartis Vaccines & Diagnostic Polypeptide-vaccines for broad protection against hypervirulent meningococcal lineages
GB0227346D0 (en) 2002-11-22 2002-12-31 Chiron Spa 741
EP2172213B1 (en) 2003-01-30 2013-04-03 Novartis AG Injectable vaccines against multiple meningococcal serogroups
GB0323103D0 (en) 2003-10-02 2003-11-05 Chiron Srl De-acetylated saccharides
PL1961426T3 (en) 2003-10-02 2012-03-30 Gsk Vaccines S R L Combined meningitis vaccines
AR047062A1 (en) 2003-12-17 2006-01-04 Wyeth Corp CONJUGATED CARRIERS OF BETA IMMUNOGENIC PEPTIDES AND METHODS FOR PRODUCERS
GB0524066D0 (en) 2005-11-25 2006-01-04 Chiron Srl 741 ii
AU2007229449A1 (en) 2006-03-22 2007-10-04 Novartis Ag Regimens for immunisation with meningococcal conjugates
US10828361B2 (en) 2006-03-22 2020-11-10 Glaxosmithkline Biologicals Sa Regimens for immunisation with meningococcal conjugates
EP2066344B2 (en) 2006-09-07 2016-06-29 GlaxoSmithKline Biologicals S.A. Inactivated Poliovirus combination vaccine
EP2682127A1 (en) 2007-05-02 2014-01-08 GlaxoSmithKline Biologicals S.A. Vaccine
GB0713880D0 (en) 2007-07-17 2007-08-29 Novartis Ag Conjugate purification
CN101951949B (en) 2007-10-19 2013-10-02 诺华股份有限公司 Meningococcal vaccine formulations
WO2009104097A2 (en) 2008-02-21 2009-08-27 Novartis Ag Meningococcal fhbp polypeptides
NZ593674A (en) 2008-12-17 2013-03-28 Novartis Ag Meningococcal vaccines including hemoglobin receptor
RU2555757C2 (en) 2009-03-24 2015-07-10 Новартис Аг Combinations of meningococcal factor-h-binding protein and pneumococcal saccharide conjugates
CN104650241A (en) 2009-08-27 2015-05-27 诺华股份有限公司 Hybrid polypeptides including meningococcal fHBP sequences
CN102724988B (en) 2009-09-30 2014-09-10 诺华股份有限公司 Expression of meningococcal fHBP polypeptides
EP2493499A1 (en) 2009-10-27 2012-09-05 Novartis AG Modified meningococcal fhbp polypeptides
CA2810971C (en) 2010-09-10 2020-11-03 Novartis Ag Developments in meningococcal outer membrane vesicles
EP2707009A1 (en) 2011-05-12 2014-03-19 Novartis AG Antipyretics to enhance tolerability of vesicle-based vaccines
CN102507924B (en) * 2011-11-17 2014-06-18 成都欧林生物科技股份有限公司 Method for detecting concentration of polysaccharide in zymotic fluid
US9657297B2 (en) 2012-02-02 2017-05-23 Glaxosmithkline Biologicals Sa Promoters for increased protein expression in meningococcus

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5604108A (en) * 1992-09-14 1997-02-18 Connaught Laboratories, Inc. Test for determining the dose response of a conjugated vaccine
WO1999033488A2 (en) * 1997-12-24 1999-07-08 Smithkline Beecham Biologicals S.A. Adjuvanted vaccine formulation
WO2000056358A2 (en) * 1999-03-19 2000-09-28 Smithkline Beecham Biologicals S.A. Vaccine against streptococcus pneumoniae capsular polysaccharides

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5604108A (en) * 1992-09-14 1997-02-18 Connaught Laboratories, Inc. Test for determining the dose response of a conjugated vaccine
WO1999033488A2 (en) * 1997-12-24 1999-07-08 Smithkline Beecham Biologicals S.A. Adjuvanted vaccine formulation
WO2000056358A2 (en) * 1999-03-19 2000-09-28 Smithkline Beecham Biologicals S.A. Vaccine against streptococcus pneumoniae capsular polysaccharides

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
AKKOYUNLU M ET AL: "The acylated form of protein D of Haemophilus influenzae is more immunogenic than the nonacylated form and elicits an adjuvant effect when it is used as a carrier conjugated to polyribosyl ribitol phosphate.", INFECTION AND IMMUNITY, (1997 DEC) 65 (12) 5010-6., XP001041693 *
DAUM, ROBERT S. ET AL: "Infant immunization with pneumococcal CRM197 vaccines: effect of saccharide size on immunogenicity and interactions with simultaneously administered vaccines", J. INFECT. DIS. (1997), 176(2), 445-455, XP001041718 *
GUPTA, RAJESH K. ET AL: "Evaluation of a guinea pig model to assess interference in the immunogenicity of different components of a combination vaccine comprising diphtheria, tetanus and acellular pertussis (DTaP) vaccine and Haemophilus influenzae type b capsular polysaccharide conjugate vaccine", BIOLOGICALS (1999), 27(2), 167-176, XP001041727 *
MICHON, FRANCIS ET AL: "Multivalent pneumococcal capsular polysaccharide conjugate vaccines employing genetically detoxified pneumolysin as a carrie protein", VACCINE (1998), 16(18), 1732-1741, XP001041691 *
ROMERO-STEINER, SANDRA ET AL: "Standardization of an opsonophagocytic assay for the measurement of functional antibody activity against Streptococcus pneumoniae using differentiated HL-60 cells", CLIN. DIAGN. LAB. IMMUNOL. (1997), 4(4), 415-422, XP001041731 *
SCHNEERSON R ET AL: "Serum antibody responses of juvenile and infant rhesus monkeys injected with Haemophilus influenzae type b and pneumococcus type 6A capsular polysaccharide -protein conjugates.", INFECTION AND IMMUNITY, (1984 SEP) 45 (3) 582-91., XP001041692 *
See also references of EP1223987A2 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9358279B2 (en) 2005-06-27 2016-06-07 Glaxosmithkline Biologicals S.A. Immunogenic composition

Also Published As

Publication number Publication date
WO2001030390A2 (en) 2001-05-03
EP1223987A2 (en) 2002-07-24
GB9925559D0 (en) 1999-12-29
AU1854901A (en) 2001-05-08
CA2388995A1 (en) 2001-05-03
JP2003512440A (en) 2003-04-02

Similar Documents

Publication Publication Date Title
WO2001030390A3 (en) Method
Brown et al. Failure of a large dose of vitamin A to enhance the antibody response to tetanus toxoid in children
Lepow et al. Safety and immunogenicity of Haemophilus influenzae type b-polysaccharide diphtheria toxoid conjugate vaccine in infants 9 to 15 months of age
Peltola et al. Rapid disappearance of Haemophilus influenzae type b meningitis after routine childhood immunisation with conjugate vaccines
Wüthrich et al. Anaphylactic reactions to ingested carmine (E120)
US6251401B1 (en) Combined meningitis vaccine
Åhman et al. Dose dependency of antibody response in infants and children to pneumococcal polysaccharides conjugated to tetanus toxoid
EP0370573A3 (en) Skin test and test kit for aids
CA2142884A1 (en) Pertussis toxin used as a carrier protein with non-charged saccharides in conjugate vaccines
EP1132097A3 (en) Cellular and serum protein anchors and conjugates
NO20101067L (en) Hydroxymatairesinol in cancer prevention
NZ505877A (en) Oral delivery of nucleic acid vaccines by particulate complexes
AU7242796A (en) Leishmania antigens for use in the therapy and diagnosis of leishmaniasis
WO2000067788A3 (en) Use of soluble costimulatory molecules to enhance immune responses
WO2005000884A8 (en) Poly-gamma-glutamic conjugates for eliciting immune responses directed against bacilli
Ono et al. Complete seroconversion by low-dose intradermal injection of recombinant hepatitis B vaccine in hemodialysis patients
WO2002034287A3 (en) Therapeutic vaccine formulations containing chitosan
PL174130B1 (en) Composite pediatric vaccine exhibiting increased immunizing power of each component thereof
Tansey Medicines and men: Burroughs, Wellcome & Co, and the British drug industry before the Second World War
WO1998036089A3 (en) Test kit for tuberculosis diagnosis by determining alanine dehydrogenase
WO1999059627A3 (en) Verotoxin b subunit for immunization
WO1999039693A3 (en) Methods and compositions for detection and diagnosis of infectious diseases
Lottenbach et al. Safety and immunogenicity of Haemophilus influenzae type B polysaccharide or conjugate vaccines in an elderly adult population
Youkeles et al. Use of streptokinase as a recall antigen for lymphocyte proliferation testing in vitro
BURKE The immunoglobulin G (IgG) of Graves’ disease: thyroid stimulation by fraction and fragment

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CR CU CZ DE DK DM DZ EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
AK Designated states

Kind code of ref document: A3

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CR CU CZ DE DK DM DZ EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A3

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

ENP Entry into the national phase

Ref country code: JP

Ref document number: 2001 532807

Kind code of ref document: A

Format of ref document f/p: F

WWE Wipo information: entry into national phase

Ref document number: 2388995

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2000981226

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 2000981226

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 10111521

Country of ref document: US

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

WWW Wipo information: withdrawn in national office

Ref document number: 2000981226

Country of ref document: EP