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StaphVAX Immunogenicity in Orthopedic Implant Patients

This study has been completed.
Sponsor:
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00211926
First received: September 13, 2005
Last updated: December 21, 2007
Last verified: December 2007
History of Changes
  Purpose

S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.


Condition Intervention Phase
Staphylococcal Infections
Joint Prosthesis
 Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Biological: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • serotype-specific antibody concentrations [ Time Frame: 6 weeks after dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serotype-specific antibody concentrations [ Time Frame: several other time points after dose, up to 365 days ] [ Designated as safety issue: No ]
  • safety: adverse events [ Time Frame: 0-365 days ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: December 2004
Study Completion Date: October 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: StaphVAX Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single dose of vaccine containing 100 mcg of each serotype conjugate
Placebo Comparator: Placebo Biological: placebo
single dose of placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 years or older
  • candidate for knee or hip replacement
  • expectation of protocol compliance
  • negative pregnancy test, where appropriate

Exclusion Criteria:

  • known S. aureus infection in the prior 3 months
  • infection in the prior 2 weeks
  • Known HIV infection
  • immunomodulatory drugs
  • Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
  • Hypersensitivity to components of StaphVAX
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211926

Locations
United States, Virginia
Cllinical Research Asociates of Tidewater
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Study Director: Preston Holley, MD Nabi Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Matt Hohenboken, MD, PhD/ Executive Director Clinical and Medical Affairs, Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00211926     History of Changes
Other Study ID Numbers: Nabi-1365
Study First Received: September 13, 2005
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:
vaccine
Staphylococcus aureus vaccine

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013