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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
Nabi Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcal Infections focused on measuring vaccine, Staphylococcus aureus vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 13, 2005
Last Updated
December 21, 2007
Sponsor
Nabi Biopharmaceuticals
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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

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StaphVAX Immunogenicity in Orthopedic Implant Patients

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