StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

This study has been completed.

Sponsor:

Collaborator:

Health Protection Agency, United Kingdom

Information provided by:

Nabi Biopharmaceuticals

ClinicalTrials.gov Identifier:

NCT00211965

First received: September 13, 2005

Last updated: December 26, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 26, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sero-type specific antibody concentrations [ Time Frame: 6 weeks after study dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Sero-type specific antibody concentrations 6 weeks after study dose.

Change History

Complete list of historical versions of study NCT00211965 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sero-type specific antibody concentrations [ Time Frame: various other time points after study dose, up to 26 wk ] [ Designated as safety issue: No ]
adverse events [ Time Frame: throughout 6 months observation after study dose ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Sero-type specific antibody concentrations at other time points after study dose.
Safety.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

Official Title ^ICMJE

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 Orthopedic Prosthetic Implant

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Staphylococcal Infections

Intervention ^ICMJE

Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
single IM dose of 200 mcg total conjugate

Other Name: StaphVAX®
Biological: placebo
single dose IM

Study Arm (s)

Experimental: vaccine
single dose

Intervention: Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
Placebo Comparator: placebo
single dose

Intervention: Biological: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00211965

Other Study ID Numbers ^ICMJE

Nabi-1363

Has Data Monitoring Committee

Responsible Party

Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nabi Biopharmaceuticals

Study Sponsor ^ICMJE

Nabi Biopharmaceuticals

Collaborators ^ICMJE

Health Protection Agency, United Kingdom

Investigators ^ICMJE

Study Director:

Matt Hohenboken, MD, PhD

Nabi Biopharmaceuticals

Information Provided By

Nabi Biopharmaceuticals

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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