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

September 13, 2005
December 26, 2007
April 2005
May 2006   (final data collection date for primary outcome measure)
Sero-type specific antibody concentrations [ Time Frame: 6 weeks after study dose ] [ Designated as safety issue: No ]
Sero-type specific antibody concentrations 6 weeks after study dose.
Complete list of historical versions of study NCT00211965 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Sero-type specific antibody concentrations at other time points after study dose.
  • Safety.
Not Provided
Not Provided
 
StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Staphylococcal Infections
  • Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
    single IM dose of 200 mcg total conjugate
    Other Name: StaphVAX®
  • Biological: placebo
    single dose IM
  • Experimental: vaccine
    single dose
    Intervention: Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
  • Placebo Comparator: placebo
    single dose
    Intervention: Biological: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
August 2006
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00211965
Nabi-1363
No
Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
Health Protection Agency, United Kingdom
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP