Document Detail

Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults.
MedLine Citation:
PMID:  11159994     Owner:  NLM     Status:  MEDLINE    
Clostridium difficile is a major cause of nosocomial diarrhea in industrialized countries. Although most illnesses respond to available therapy, infection can increase morbidity, prolong hospitalization, and produce life-threatening colitis. Vaccines are being explored as an alternative means for protecting high-risk individuals. We assessed the safety, immunogenicity, and dose response of a parenteral vaccine containing C. difficile toxoids A and B. Thirty healthy adults were assigned to receive four spaced inoculations on days 1, 8, 30, and 60 with one of three doses of vaccine (6.25, 25, or 100 microg). At each dose level, subjects were randomized, in a double-blind fashion, to receive either the soluble toxoids (n = 5) or toxoids adsorbed to alum (n = 5). Subjects were monitored for clinical and immunologic responses to vaccination. Vaccination was generally well tolerated, with occasional, usually mild, systemic reactions (abdominal pain, arthralgia, and diarrhea). The most common local reaction, mild arm pain, was reported by all recipients of the toxoid-alum formulation. Nearly all subjects (> or = 90%) developed vigorous serum antibody responses to both toxins, as measured by immunoglobulin G (IgG) enzyme-linked immunosorbent assay and neutralization of cytotoxicity, whereas fecal IgA increases occurred in approximately 50%. Statistically significant effects of dose and formulation on immunogenicity were not seen, although antibody levels tended to be higher with the alum-adjuvanted formulations and with increasing doses of soluble toxoid. Serum antibody responses among the toxoid-alum group appeared to plateau at 25 microg. We concluded that the C. difficile toxoid vaccine is safe and immunogenic in healthy volunteers. Further development as a prophylactic vaccine or for producing C. difficile hyperimmune globulin is justified.
K L Kotloff; S S Wasserman; G A Losonsky; W Thomas; R Nichols; R Edelman; M Bridwell; T P Monath
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Infection and immunity     Volume:  69     ISSN:  0019-9567     ISO Abbreviation:  Infect. Immun.     Publication Date:  2001 Feb 
Date Detail:
Created Date:  2001-02-22     Completed Date:  2001-03-15     Revised Date:  2013-04-17    
Medline Journal Info:
Nlm Unique ID:  0246127     Medline TA:  Infect Immun     Country:  United States    
Other Details:
Languages:  eng     Pagination:  988-95     Citation Subset:  IM    
Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA.
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MeSH Terms
Antibodies, Bacterial / blood
Bacterial Vaccines / adverse effects*,  immunology
Clostridium difficile / immunology*
Dose-Response Relationship, Immunologic
Double-Blind Method
Enzyme-Linked Immunosorbent Assay
Immunoglobulin A, Secretory / biosynthesis
Immunoglobulin G / blood
Middle Aged
Toxoids / immunology*
Grant Support
Reg. No./Substance:
0/Antibodies, Bacterial; 0/Bacterial Vaccines; 0/Immunoglobulin A, Secretory; 0/Immunoglobulin G; 0/Toxoids

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