WO1998051338A1 - PROCEDE D'ADMINISTRATION DE VACCIN CONTRE LES INFECTIONS A $i(SHIGELLA) - Google Patents

PROCEDE D'ADMINISTRATION DE VACCIN CONTRE LES INFECTIONS A $i(SHIGELLA) Download PDF

Info

Publication number
WO1998051338A1
WO1998051338A1 PCT/US1998/010042 US9810042W WO9851338A1 WO 1998051338 A1 WO1998051338 A1 WO 1998051338A1 US 9810042 W US9810042 W US 9810042W WO 9851338 A1 WO9851338 A1 WO 9851338A1
Authority
WO
WIPO (PCT)
Prior art keywords
cfu
shigella
administration
dose
organisms
Prior art date
Application number
PCT/US1998/010042
Other languages
English (en)
Inventor
Thomas L. Hale
Trinka S. Coster
Original Assignee
U.S. Government, Department Of The Army U.S. Army Medical Research & Materiel Command
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 U.S. Government, Department Of The Army U.S. Army Medical Research & Materiel Command filed Critical U.S. Government, Department Of The Army U.S. Army Medical Research & Materiel Command
Publication of WO1998051338A1 publication Critical patent/WO1998051338A1/fr

Links

Classifications

    • 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
    • A61K39/025—Enterobacteriales, e.g. Enterobacter
    • A61K39/0283—Shigella
    • 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

Definitions

  • This invention relates to the field of vaccination against shigellosis. While other means of achieving protection from shigellosis are known, the instant invention makes it possible to administer a single, smaller dosage than was previously suggested for purposes of obtaining protection.
  • a transformed Shigella has been disclosed in European application EP 351322. That disclosure suggests that the preferred dosage for administration contains 10 8 to 10 11 cells of the lyophilized Shigella. At this level, the subjects often developed signs of morbidity related to shigellosis, including diarrhea and elevated temperature. Using the methods of the instant invention, it is possible to reliably protect from shigellosis using a smaller dosage of organisms whilst avoiding uncomfortable side effects which developed when using the large number of organisms as suggested by the prior art.
  • This invention relates to means for administration of organisms to protect against intestinal infection. Using means of the instant invention it was possible to obtain protection from shigellosis by administration of one dose of about 10 4 colony forming units (CFU) of Shigella.
  • CFU colony forming units
  • the method consists of administration of a single dose of 10,000 CFU of Shigella organisms characterized by the ability to bind Congo red dye when cultured on a Trypticase Soy Agar plate.
  • the method of the invention for vaccinating a susceptible host against Shigella species comprises the steps of:
  • reconstituted CS602 product is diluted to attain the 10,000 CFU of organisms suspended in 30 ml of sodium bicarbonate solution (3.2 g per 240 ml of water) .
  • the vaccinee ingests 120 ml of the sodium bicarbonate solution (3.2 g/240 ml of water) five minutes before ingesting the vaccine dose of 10,000 CFU suspended in 30 ml of bicarbonate solution.
  • the 10 4 CFU dose of SC602 appeared to be more appropriate for administration under the conditions wherein bicarbonate is administered to buffer the acidity of the upper intestinal tract. Robust intestinal colonization was observed in all volunteers ingesting > . 10 4 CFU of SC602 vaccine. For example, 8 of 15 volunteers inoculated with 2 X 10 6 CFU excreted the organisms until Ciprofloxacin treatment commenced twelve days after vaccination. After vaccination with 1 X 10 4 CFU of SC602, 11 of 12 volunteers shed shigellae until Ciprofloxacin treatment commenced the eighth day.
  • D arrhea two or more grade 3 stools within 48 hours equaling 200 ml or one grade 3 stool of >300 ml within 24 hours.
  • Dysentery one or more >grade 3 stools with gross blood.
  • Table 1 summarizes the clinical and bacteriological parameters associated with ingestion of 1 - 5 X 10 CFU of SC602 in three Phase 1 trials.
  • one volunteer experienced diarrheal stools associated with ingestion of this dosage.
  • three additional vaccinees reported 3 to 5 small volume diarrheal stools over a period of a few hours.
  • One of these volunteers had a fever of 102.5 °F and another had slight fever of 100.6 °F.
  • the diarrhea and/or fever reported by vaccinees during the November study was of short duration and did not prevent normal activities.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Nouveau procédé de vaccination d'un hôte susceptible contre des espèces Shigella qui consiste (1) à administrer une solution tampon à une personne vaccinée en quantité suffisante pour tamponner l'acidité du tractus gastro-intestinal et (b) à administrer une dose d'environ 104 CFU d'organismes Shigella dans une solution alcaline. Ledit procédé réduit la morbidité et fournit en outre une excellente protection contre la shigellose.
PCT/US1998/010042 1997-05-16 1998-05-15 PROCEDE D'ADMINISTRATION DE VACCIN CONTRE LES INFECTIONS A $i(SHIGELLA) WO1998051338A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5100497P 1997-05-16 1997-05-16
US60/051,004 1997-05-16

Publications (1)

Publication Number Publication Date
WO1998051338A1 true WO1998051338A1 (fr) 1998-11-19

Family

ID=21968784

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/010042 WO1998051338A1 (fr) 1997-05-16 1998-05-15 PROCEDE D'ADMINISTRATION DE VACCIN CONTRE LES INFECTIONS A $i(SHIGELLA)

Country Status (1)

Country Link
WO (1) WO1998051338A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5077044A (en) * 1980-05-19 1991-12-31 The Board Of Trustees Of The Leland Stanford Jr. University Novel non-reverting shigella live vaccines

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5077044A (en) * 1980-05-19 1991-12-31 The Board Of Trustees Of The Leland Stanford Jr. University Novel non-reverting shigella live vaccines

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CHEMICAL ABSTRACTS, 1 January 1900, Columbus, Ohio, US; abstract no. 125:273124, KOTLOFF K L, ET AL: "Safety, Immunogenicity and Transmissibility in Humans of CVD 1203, a Live Oral Shigella Flexneri 2a Vaccine Candidate Attenuated by Deletions in aroA and virG" XP002911787 *

Similar Documents

Publication Publication Date Title
Tacket et al. Initial clinical studies of CVD 112 Vibrio cholerae O139 live oral vaccine: safety and efficacy against experimental challenge
Morris Jr et al. Clinical and immunologic characteristics of Vibrio cholerae O139 Bengal infection in North American volunteers
Killeen et al. Safety, immunogenicity, and efficacy of live attenuated Vibrio cholerae 0139 vaccine prototype
Dubois et al. Host specificity of Helicobacter pylori strains and host responses in experimentally challenged nonhuman primates
Kotloff et al. Evaluation of the safety, immunogenicity, and efficacy in healthy adults of four doses of live oral hybrid Escherichia coli-Shigella flexneri 2a vaccine strain EcSf2a-2
Evans et al. Administration of purified colonization factor antigens (CFA/I, CFA/II) of enterotoxigenic Escherichia coli to volunteers: response to challenge with virulent enterotoxigenic Escherichia coli
Rollins et al. Yersinia pestis and the plague
KR20140053887A (ko) 면역 반응을 증진시키는 조성물 및 방법
US8092793B2 (en) Treating inflammatory bowel disease with live bacteria
KR100333113B1 (ko) 헬리코박터피롤리관련위십이지장질환의치료방법
Taylor et al. Evaluation of a bivalent (CVD 103-HgR/CVD 111) live oral cholera vaccine in adult volunteers from the United States and Peru
AU2006328209A1 (en) Method of producing rough strains of bacteria and uses thereof
JP3601602B2 (ja) 無毒性微生物及びその使用：サルモネラ
CN105663171B (zh) 用于口服递送的活细胞制剂
JP2003533489A (ja) 粘膜感染症の処置のための組成物および方法
Levine et al. Shigellosis in custodial institutions: II. Clinical, immunologic and bacteriologic response of institutionalized children to oral attenuated shigella vaccines
Woodward Volunteer studies of typhoid fever and vaccines
Chen et al. Host responses induced by co‐infection with Porphyromonas gingivalis and Actinobacillus actinomycetemcomitans in a murine model
Tacket et al. Lack of immune response to the Vi component of a Vi-positive variant of the Salmonella typhi live oral vaccine strain Ty21a in human studies
KR101373770B1 (ko) 백지 추출물을 유효성분으로 함유하는 장출혈성 대장균 감염증의 예방 또는 치료용 약학 조성물
Waldman et al. Oral immunization of mice with killed Salmonella typhimurium vaccine
Woodward Rickettsial vaccines with emphasis on epidemic typhus-initial report of an old vaccine trial
WO1998051338A1 (fr) PROCEDE D'ADMINISTRATION DE VACCIN CONTRE LES INFECTIONS A $i(SHIGELLA)
Xing et al. Effect of pertussis toxin on the induction of nitric oxide synthesis in murine macrophages and on protection in vivo
Glass et al. A randomized, controlled trial of the toxin-blocking effects of B subunit in family members of patients with cholera

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): CA JP US

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: JP

Ref document number: 1998549615

Format of ref document f/p: F

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: CA