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StaphVAX (Nabi).

Taff Jones1

  • 1Intellivax International Inc, Ville St-Laurent, Quebec, Canada. tjones@intellivax.com

Current Opinion in Investigational Drugs (London, England : 2000)
|June 11, 2002
PubMed
Summary
This summary is machine-generated.

StaphVAX, a vaccine targeting Staphylococcus aureus types 5 and 8, is under development for kidney patients on dialysis. Further trials are planned after the FDA requested more efficacy data for licensing.

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Area of Science:

  • Immunology
  • Vaccinology
  • Nephrology

Background:

  • Staphylococcus aureus infections are a significant risk for patients undergoing peritoneal dialysis.
  • StaphVAX is a bivalent conjugate vaccine targeting S. aureus types 5 and 8, responsible for 80-90% of infections.

Purpose of the Study:

  • To evaluate the efficacy and safety of StaphVAX in preventing S. aureus infections in end-stage renal disease (ESRD) patients.
  • To conduct a boosting study in ESRD patients previously enrolled in a Phase III trial.

Main Methods:

  • A bivalent polysaccharide- and protein-conjugated vaccine (StaphVAX) was developed.
  • A Phase III trial was conducted in patients with ESRD.
  • A subsequent boosting study and a second Phase III trial were planned.

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Main Results:

  • The FDA required a definitive demonstration of preventative efficacy in an additional randomized, controlled clinical study for vaccine licensing.
  • Nabi planned to conduct a boosting study and a second Phase III trial.

Conclusions:

  • Further clinical studies are necessary to meet FDA requirements for StaphVAX approval.
  • Development of StaphVAX continues, with plans for further trials and manufacturing scale-up.