StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

Phase 3CompletedNCT00211965

Nabi Biopharmaceuticals67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Staphylococcal Infections

Interventions

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 prostate cancer) * Hypersensitivity to components of StaphVAX

Outcomes

Primary Outcomes

Sero-type specific antibody concentrations

Time frame: 6 weeks after study dose

Secondary Outcomes

Sero-type specific antibody concentrations

Time frame: various other time points after study dose, up to 26 wk

adverse events

Time frame: throughout 6 months observation after study dose