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StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

This study has been completed.
Sponsor:
Collaborator:
Health Protection Agency, United Kingdom
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00211965
First received: September 13, 2005
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  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
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 Orthopedic Prosthetic Implant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nabi Biopharmaceuticals:

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

Secondary Outcome Measures:
  • Sero-type specific antibody concentrations [ Time Frame: various other time points after study dose, up to 26 wk ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: throughout 6 months observation after study dose ] [ Designated as safety issue: Yes ]

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

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 prostate cancer)
  • Hypersensitivity to components of StaphVAX
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211965

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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: December 26, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 16, 2013