StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

Phase 3

Completed

• Conditions: Staphylococcal Infections
• Interventions: Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate; Biological: placebo

• Registration Number: NCT00211965
• Lead Sponsor: Nabi Biopharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-05
• Study Completion: 2006-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-26
• Last Update Posted: 2008-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaccine	S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate	single dose
placebo	placebo	single dose

Primary Outcome Measures

Name	Time	Method
Sero-type specific antibody concentrations	6 weeks after study dose

Secondary Outcome Measures

Name	Time	Method
adverse events	throughout 6 months observation after study dose
Sero-type specific antibody concentrations	various other time points after study dose, up to 26 wk

Trial Locations

Locations (1)

National Royal Orthopaedic Hospital; 🇬🇧 Stanmore, Middlesex, United Kingdom