title: Use of a Staphylococcus aureus conjugate vaccine in patients receiving hemodialysis.
abstract: BACKGROUND
  In patients with decreased resistance to infection, Staphylococcus aureus is a major cause of bacteremia and its complications. The capsular polysaccharides are essential for the pathogenesis of and immunity to S. aureus infection and are targets for vaccines.
  
  
  METHODS
  In a double-blind trial involving patients with end-stage renal disease who were receiving hemodialysis, we evaluated the safety, immunogenicity, and efficacy of a vaccine with S. aureus type 5 and 8 capsular polysaccharides conjugated to nontoxic recombinant Pseudomonas aeruginosa exotoxin A. Between April 1998 and August 1999, 1804 adult patients at 73 hemodialysis centers were randomly assigned to receive a single intramuscular injection of either vaccine or saline. IgG antibodies to S. aureus type 5 and 8 capsular polysaccharides were measured for up to two years, and episodes of S. aureus bacteremia were recorded. Efficacy was estimated by comparing the incidence of S. aureus bacteremia in the patients who received the vaccine with the incidence in the control patients.
  
  
  RESULTS
  Reactions to the vaccine were generally mild to moderate, and most resolved within two days. The capsular polysaccharides elicited an antibody response of at least 80 microg per milliliter (the estimated minimal level conferring protection) in 80 percent of patients for type 5 and in 75 percent of patients for type 8. The efficacy during weeks 3 to 54 was only 26 percent (P=0.23). However, between weeks 3 and 40 after vaccination, S. aureus bacteremia developed in 11 of 892 patients in the vaccine group who could be evaluated for bacteremia, as compared with 26 of 906 patients in the control group (estimate of efficacy, 57 percent; 95 percent confidence interval, 10 to 81 percent; nominal P=0.02).
  
  
  CONCLUSIONS
  In patients receiving hemodialysis, a conjugate vaccine can confer partial immunity against S. aureus bacteremia for approximately 40 weeks, after which protection wanes as antibody levels decrease.
authors.affiliation: Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA. henry.shinefield@kp.org
authors.forename: Henry
authors.initials: H
authors.lastname: Shinefield
authors.forename: Steven
authors.initials: S
authors.lastname: Black
authors.forename: Ali
authors.initials: A
authors.lastname: Fattom
authors.forename: Gary
authors.initials: G
authors.lastname: Horwith
authors.forename: Scott
authors.initials: S
authors.lastname: Rasgon
authors.forename: Juan
authors.initials: J
authors.lastname: Ordonez
authors.forename: Hock
authors.initials: H
authors.lastname: Yeoh
authors.forename: David
authors.initials: D
authors.lastname: Law
authors.forename: John B
authors.initials: JB
authors.lastname: Robbins
authors.forename: Rachel
authors.initials: R
authors.lastname: Schneerson
authors.forename: Larry
authors.initials: L
authors.lastname: Muenz
authors.forename: Steve
authors.initials: S
authors.lastname: Fuller
authors.forename: Joanie
authors.initials: J
authors.lastname: Johnson
authors.forename: Bruce
authors.initials: B
authors.lastname: Fireman
authors.forename: Harry
authors.initials: H
authors.lastname: Alcorn
authors.forename: Robert
authors.initials: R
authors.lastname: Naso
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D016470:Bacteremia / Q000209:etiology / Q000517:prevention & control*; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology; D004311:Double-Blind Method; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D006435:Renal Dialysis; D013203:Staphylococcal Infections / Q000209:etiology / Q000276:immunology / Q000517:prevention & control*; D013209:Staphylococcal Vaccines; D013211:Staphylococcus aureus / Q000145:classification / Q000276:immunology / Q000302:isolation & purification; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; C423263:StaphVax; D013209:Staphylococcal Vaccines; D018074:Vaccines, Conjugate