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StaphVAX Immunogenicity in Orthopedic Implant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00211926
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 4, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Staphylococcal Infections Joint Prosthesis Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate Biological: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2004
Primary Completion Date : June 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. serotype-specific antibody concentrations [ Time Frame: 6 weeks after dose ]

Secondary Outcome Measures :
  1. serotype-specific antibody concentrations [ Time Frame: several other time points after dose, up to 365 days ]
  2. safety: adverse events [ Time Frame: 0-365 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: December 2007

Keywords provided by Nabi Biopharmaceuticals:
vaccine
Staphylococcus aureus vaccine

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs