StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
Primary Purpose
Staphylococcal Infections
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcal Infections focused on measuring Knee replacement surgery, hip replacement surgery, nosocomial infections, Arthroplasty
Eligibility 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
Sites / Locations
- National Royal Orthopaedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
vaccine
placebo
Arm Description
single dose
single dose
Outcomes
Primary Outcome Measures
Sero-type specific antibody concentrations
Secondary Outcome Measures
Sero-type specific antibody concentrations
adverse events
Full Information
NCT ID
NCT00211965
First Posted
September 13, 2005
Last Updated
December 26, 2007
Sponsor
Nabi Biopharmaceuticals
Collaborators
Public Health England
1. Study Identification
Unique Protocol Identification Number
NCT00211965
Brief Title
StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nabi Biopharmaceuticals
Collaborators
Public Health England
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
Keywords
Knee replacement surgery, hip replacement surgery, nosocomial infections, Arthroplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vaccine
Arm Type
Experimental
Arm Description
single dose
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
single dose
Intervention Type
Biological
Intervention Name(s)
S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
Other Intervention Name(s)
StaphVAX®
Intervention Description
single IM dose of 200 mcg total conjugate
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
single dose IM
Primary Outcome Measure Information:
Title
Sero-type specific antibody concentrations
Time Frame
6 weeks after study dose
Secondary Outcome Measure Information:
Title
Sero-type specific antibody concentrations
Time Frame
various other time points after study dose, up to 26 wk
Title
adverse events
Time Frame
throughout 6 months observation after study dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Hohenboken, MD, PhD
Organizational Affiliation
Nabi Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
National Royal Orthopaedic Hospital
City
Stanmore
State/Province
Middlesex
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
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