StaphVAX Immunogenicity in Orthopedic Implant Patients
Primary Purpose
Staphylococcal Infections, Joint Prosthesis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcal Infections focused on measuring vaccine, Staphylococcus aureus vaccine
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 stage prostate cancer) Hypersensitivity to components of StaphVAX
Sites / Locations
- Cllinical Research Asociates of Tidewater
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
StaphVAX
Placebo
Arm Description
Outcomes
Primary Outcome Measures
serotype-specific antibody concentrations
Secondary Outcome Measures
serotype-specific antibody concentrations
safety: adverse events
Full Information
NCT ID
NCT00211926
First Posted
September 13, 2005
Last Updated
December 21, 2007
Sponsor
Nabi Biopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00211926
Brief Title
StaphVAX Immunogenicity in Orthopedic Implant Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nabi Biopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections, Joint Prosthesis
Keywords
vaccine, Staphylococcus aureus vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
StaphVAX
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Intervention Description
single dose of vaccine containing 100 mcg of each serotype conjugate
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
single dose of placebo
Primary Outcome Measure Information:
Title
serotype-specific antibody concentrations
Time Frame
6 weeks after dose
Secondary Outcome Measure Information:
Title
serotype-specific antibody concentrations
Time Frame
several other time points after dose, up to 365 days
Title
safety: adverse events
Time Frame
0-365 days
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 stage prostate cancer)
Hypersensitivity to components of StaphVAX
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preston Holley, MD
Organizational Affiliation
Nabi Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cllinical Research Asociates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
StaphVAX Immunogenicity in Orthopedic Implant Patients
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