StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery - Full Text View

Sponsors and Collaborators:	Nabi Biopharmaceuticals Health Protection Agency
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00211965

Purpose

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.

Condition	Intervention	Phase
Staphylococcal Infections	Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate Biological: placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Staphylococcal Infections Surgery

U.S. FDA Resources

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	67
Study Start Date:	April 2005
Study Completion Date:	August 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
vaccine: Experimental single dose	Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate single IM dose of 200 mcg total conjugate
placebo: Placebo Comparator single dose	Biological: placebo single dose IM

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211965

Locations

United Kingdom, Middlesex
National Royal Orthopaedic Hospital
Stanmore, Middlesex, United Kingdom, HA7 4LP

Sponsors and Collaborators

Nabi Biopharmaceuticals

Health Protection Agency

Investigators

Study Director:

Matt Hohenboken, MD, PhD

Nabi Biopharmaceuticals

More Information

No publications provided

Responsible Party:	Nabi Biopharmaceuticals ( Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs )
Study ID Numbers:	Nabi-1363
Study First Received:	September 13, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00211965 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Nabi Biopharmaceuticals:

Knee replacement surgery
hip replacement surgery
nosocomial infections
Arthroplasty

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Infection

ClinicalTrials.gov processed this record on September 02, 2009