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StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211965
First Posted: September 21, 2005
Last Update Posted: January 4, 2008
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.
Collaborator:
Public Health England
Information provided by:
Nabi Biopharmaceuticals
  Purpose
Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for orthopedic surgery.

Condition Intervention Phase
Staphylococcal Infections Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate Biological: placebo Phase 3

Study Type: Interventional
Study Design: 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 Orthopedic Prosthetic Implant

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Sero-type specific antibody concentrations [ Time Frame: 6 weeks after study dose ]

Secondary Outcome Measures:
  • Sero-type specific antibody concentrations [ Time Frame: various other time points after study dose, up to 26 wk ]
  • adverse events [ Time Frame: throughout 6 months observation after study dose ]

Enrollment: 67
Study Start Date: April 2005
Study Completion Date: August 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccine
single dose
Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
single IM dose of 200 mcg total conjugate
Other Name: StaphVAX®
Placebo Comparator: placebo
single dose
Biological: placebo
single dose IM

  Eligibility

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 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): NCT00211965


Locations
United Kingdom
National Royal Orthopaedic Hospital
Stanmore, Middlesex, United Kingdom, HA7 4LP
Sponsors and Collaborators
Nabi Biopharmaceuticals
Public Health England
Investigators
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
  More Information

Responsible Party: Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00211965     History of Changes
Other Study ID Numbers: Nabi-1363
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: January 4, 2008
Last Verified: December 2007

Keywords provided by Nabi Biopharmaceuticals:
Knee replacement surgery
hip replacement surgery
nosocomial infections
Arthroplasty

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