StaphVAX Immunogenicity in Orthopedic Implant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Staphylococcal Infections Joint Prosthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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StaphVAX

Group Type EXPERIMENTAL

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Intervention Type BIOLOGICAL

single dose of vaccine containing 100 mcg of each serotype conjugate

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

single dose of placebo

Interventions

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S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

single dose of vaccine containing 100 mcg of each serotype conjugate

Intervention Type BIOLOGICAL

placebo

single dose of placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes