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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014