EP0877623A1 - Intranasal vaccination against gastrointestinal disease - Google Patents

Intranasal vaccination against gastrointestinal disease

Info

Publication number
EP0877623A1
EP0877623A1 EP96924312A EP96924312A EP0877623A1 EP 0877623 A1 EP0877623 A1 EP 0877623A1 EP 96924312 A EP96924312 A EP 96924312A EP 96924312 A EP96924312 A EP 96924312A EP 0877623 A1 EP0877623 A1 EP 0877623A1
Authority
EP
European Patent Office
Prior art keywords
toxin
difficile
composition
toxoid
immunization
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP96924312A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0877623A4 (enrdf_load_stackoverflow
Inventor
William D. Thomas, Jr.
Thomas P. Monath
Francisco Torres-Lopez
Zhenxi Zhang
Wende Lei
David M. Lyerly
James S. Moncrief
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Pasteur Biologics LLC
Original Assignee
OraVax Inc
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 OraVax Inc filed Critical OraVax Inc
Publication of EP0877623A4 publication Critical patent/EP0877623A4/xx
Publication of EP0877623A1 publication Critical patent/EP0877623A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/08Clostridium, e.g. Clostridium tetani
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541Mucosal route
    • A61K2039/543Mucosal route intranasal
    • 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
    • A61K2039/55511Organic adjuvants
    • A61K2039/55544Bacterial toxins
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • Pathogens to which mucosal immune responses may be induced in the methods of the invention, and from which the antigens (e.g., non-replicatable polypeptide antigens) may be derived include, but are not limited to gastrointestinal pathogens such as Helicobacter ⁇ (e.g., H. pylori , H. feli ⁇ , and H. heilmanii) , Campylobacters (e.g., C. jejuni) , pathogens which cause diarrhea and colitis (e.g., Clostridia (e.g., C. difficile, C. novyi , and C. sordellii) , enterotoxigenic E.
  • Helicobacter ⁇ e.g., H. pylori , H. feli ⁇ , and H. heilmanii
  • Campylobacters e.g., C. jejuni
  • pathogens which cause diarrhea and colitis e.g., Clostridia
  • the toxin polypeptides can be produced in a prokaryotic host (e.g., E. coli) or in a eukaryotic host (e.g., yeast cells (e.g., Saccharomyces cerevisiae) , mammalian cells (e.g., COS1, NIH3T3, or JEG3 cells), or arthropod cells (e.g., Spodoptera frugiperda (SF9) cells) ) .
  • yeast cells e.g., Saccharomyces cerevisiae
  • mammalian cells e.g., COS1, NIH3T3, or JEG3 cells
  • arthropod cells e.g., Spodoptera frugiperda (SF9) cells
  • IMR-90 fibroblast cells were grown to confluence in 96-well plates in D-MEM media (Gibco, Grand Island, NY) containing 10% fetal calf serum.
  • the minimal dose of Toxin A or Toxin B needed to cause 100% rounding of the cells was defined as 1 cytotoxic unit (CTU 100 ) .
  • CTU 100 cytotoxic unit
  • Toxin A 6.3 ng/ml
  • Toxin B 125 pg/ml
  • Two-fold dilutions of the hamster serum samples ranging from 1:100 to 12,800, were mixed with 4CTU 100 of either toxin, incubated for 1 hour at 37°C, and the mixture was then added to the cells.
  • the cultures were centrifuged and the pellets were washed three times with PBS.
  • the pellets were resuspended in 250 ⁇ l of 3% SDS in PBS, and the lysates were fractionated by electrophoresis in a 12% preparative SDS- polyacrylamide gel (Bio-Rad, Hercules, CA) at 200 volts for 1 hour. Proteins were transferred from the gel to nitrocellulose at 150 volts for 1.2 hours in a Bethesda Research Laboratories Mini-V 8-10 chamber (Life Technologies, Grand Island, NY) .
  • Serum antibodies against C. difficile antigens were measured in hamsters from all experimental groups. Immune responses to Toxin A after the priming immunization were studied by ELISA in some of the groups. No specific IgG was detected in animals vaccinated by the i.n.i.p., r., and w.c.r. routes on days 2, 4, and 7 after the initial vaccine dose. In the parenterally immunized animals (i.p. and s.c), no response was evident after days 2 and 4, but at day 7, a slight rise in antibody titer was observed. In contrast, the antibody responses measured after the last vaccine dose (day 36) demonstrated sero-conversion in all groups. The absence of early (anamnestic) antibody responses to the first vaccine dose shows that the animals were immunologically naive and had not previously been primed with Toxin A.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Urology & Nephrology (AREA)
  • Reproductive Health (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP96924312A 1995-07-07 1996-06-26 Intranasal vaccination against gastrointestinal disease Withdrawn EP0877623A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US49922995A 1995-07-07 1995-07-07
US499229 1995-07-07
PCT/US1996/010987 WO1997002835A1 (en) 1995-07-07 1996-06-26 Intranasal vaccination against gastrointestinal disease

Publications (2)

Publication Number Publication Date
EP0877623A4 EP0877623A4 (enrdf_load_stackoverflow) 1998-11-18
EP0877623A1 true EP0877623A1 (en) 1998-11-18

Family

ID=23984386

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96924312A Withdrawn EP0877623A1 (en) 1995-07-07 1996-06-26 Intranasal vaccination against gastrointestinal disease

Country Status (8)

Country Link
EP (1) EP0877623A1 (enrdf_load_stackoverflow)
JP (1) JPH11510793A (enrdf_load_stackoverflow)
CN (1) CN1195993A (enrdf_load_stackoverflow)
AU (1) AU722653B2 (enrdf_load_stackoverflow)
CA (1) CA2226392A1 (enrdf_load_stackoverflow)
NZ (1) NZ312876A (enrdf_load_stackoverflow)
WO (1) WO1997002835A1 (enrdf_load_stackoverflow)
ZA (1) ZA965737B (enrdf_load_stackoverflow)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6153201A (en) * 1993-03-09 2000-11-28 University Of Rochester Oral immunization with papillomavirus virus-like particles
US6969520B2 (en) 1997-10-20 2005-11-29 Acambis Inc. Active immunization against clostridium difficile disease
US6585975B1 (en) * 1998-04-30 2003-07-01 Acambis, Inc. Use of Salmonella vectors for vaccination against helicobacter infection
US7074454B1 (en) 1999-11-01 2006-07-11 Mucovax Holding B.V. Production of mammary secretion antibodies in farm animals
AU779776B2 (en) * 1999-11-01 2005-02-10 W. Health L.P. Production of mammary secretion antibodies in farm animals
US6974573B2 (en) 1999-11-01 2005-12-13 Mucovax Holdings, B.V. Antibody production in farm animals
GB0029919D0 (en) * 2000-12-07 2001-01-24 Chiron Spa Helicobacter pylori prime & boost vaccination
WO2008146830A1 (ja) * 2007-05-28 2008-12-04 The Kitasato Institute パラ百日咳菌全菌体ワクチン組成物
NO2198007T3 (enrdf_load_stackoverflow) * 2007-09-14 2018-03-24
EP2373332A1 (en) * 2008-12-03 2011-10-12 Boehringer Ingelheim Vetmedica GmbH Process for production of vaccines
WO2011068953A2 (en) * 2009-12-02 2011-06-09 Tufts University Atoxic recombinant holotoxins of clostridium difficile as immunogens
EP4365196A3 (en) 2011-04-22 2024-08-07 Wyeth LLC Compositions relating to a mutant clostridium difficile toxin and methods thereof
WO2013071409A1 (en) 2011-11-18 2013-05-23 National Research Council Of Canada (Nrc) Clostridium difficile lipoteichoic acid and uses thereof
BR122016023101B1 (pt) 2012-10-21 2022-03-22 Pfizer Inc Polipeptídeo, composição imunogênica que o compreende, bem como célula recombinante derivada de clostridium difficile

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4141970A (en) * 1975-05-07 1979-02-27 Internationale Octrooimaatschappij "Octropa" B.V. Method for enhancing the resistance of new born mammalian young to gastro-intestinal infections
US4713240A (en) * 1985-04-04 1987-12-15 Research Corporation Vaccines based on insoluble supports
US4944942A (en) * 1987-08-27 1990-07-31 Mobay Corporation Intranasal vaccination of horses with inactivated microorganisms or antigenic material
JP2849632B2 (ja) * 1988-04-08 1999-01-20 社団法人北里研究所 ワクチン製剤
US5601823A (en) * 1989-10-31 1997-02-11 Ophidian Pharmaceuticals, Inc. Avian antitoxins to clostridium difficle toxin A
GB9209118D0 (en) * 1992-04-28 1992-06-10 Sb 120 Amsterdam Bv Vaccine compositions
AU4773293A (en) * 1992-07-16 1994-02-14 Oxford University Multiple particulate antigen delivery system

Also Published As

Publication number Publication date
ZA965737B (en) 1997-05-13
JPH11510793A (ja) 1999-09-21
EP0877623A4 (enrdf_load_stackoverflow) 1998-11-18
AU722653B2 (en) 2000-08-10
CA2226392A1 (en) 1997-01-30
AU6479996A (en) 1997-02-10
WO1997002835A1 (en) 1997-01-30
NZ312876A (en) 2000-06-23
CN1195993A (zh) 1998-10-14

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