title: Immunogenicity and safety of recombinant Helicobacter pylori urease in a nonhuman primate.
abstract: Groups of squirrel monkeys (Saimiri spp.), predetermined to be free of Helicobacter infections in the gastric mucosa, were immunized orally with 0.5-4.5 mg of Helicobacter pylori recombinant urease (rUrease) and 25-500 micrograms of Escherichia coli heat-labile enterotoxin (LT) adjuvant. Oral immunization with rUrease resulted in a markedly elevated serum immunoglobulin G (IgG) antibody response with peak levels at 45 days after immunization. No significant gastric inflammation or cytotoxicity was evident in rUrease immunized monkeys as determined by light and electron microscopy. Twenty-five micrograms of LT was a sufficient and safe adjuvant dosage, whereas higher dosages resulted in diarrhea and lethargy. Animals developed a serum IgG antibody response to LT that did not impede the production of anti-rUrease antibody levels. The results of this investigation indicate that rUrease is immunogenic in a nonhuman primate.
authors.affiliation: Greenville Hospital System/Clemson University Biomedical Cooperative, Department of Microbiology, South Carolina 29634, USA.
authors.forename: C T
authors.initials: CT
authors.lastname: Stadtländer
authors.forename: J D
authors.initials: JD
authors.lastname: Gangemi
authors.forename: S S
authors.initials: SS
authors.lastname: Khanolkar
authors.forename: C M
authors.initials: CM
authors.lastname: Kitsos
authors.forename: H E
authors.initials: HE
authors.lastname: Farris
authors.forename: L K
authors.initials: LK
authors.lastname: Fulton
authors.forename: J E
authors.initials: JE
authors.lastname: Hill
authors.forename: F K
authors.initials: FK
authors.lastname: Huntington
authors.forename: C K
authors.initials: CK
authors.lastname: Lee
authors.forename: T P
authors.initials: TP
authors.lastname: Monath
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000818:Animals; D001427:Bacterial Toxins / Q000008:administration & dosage / Q000276:immunology*; D001706:Biopsy; D004768:Enterotoxins / Q000008:administration & dosage / Q000276:immunology*; D004926:Escherichia coli; D029968:Escherichia coli Proteins; D007074:Immunoglobulin G / Q000097:blood*; D008854:Microscopy, Electron; D012453:Saimiri; D013270:Stomach / Q000166:cytology / Q000187:drug effects; D014510:Urease / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D001427:Bacterial Toxins; D004768:Enterotoxins; D029968:Escherichia coli Proteins; D007074:Immunoglobulin G; C027538:heat-labile enterotoxin, E coli; D014510:Urease