StaphVAX Immunogenicity in Orthopedic Implant Patients

Phase 3CompletedNCT00211926

Nabi Biopharmaceuticals120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Staphylococcal Infections Joint Prosthesis

Interventions

S. aureus Type 5 & 8 Capsular Polysaccharide ConjugateBIOLOGICAL

single dose of vaccine containing 100 mcg of each serotype conjugate

placeboBIOLOGICAL

single dose of placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cllinical Research Asociates of Tidewater

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

serotype-specific antibody concentrations

Time frame: 6 weeks after dose

Secondary Outcomes

serotype-specific antibody concentrations

Time frame: several other time points after dose, up to 365 days

safety: adverse events

Time frame: 0-365 days

Data from ClinicalTrials.gov

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