StaphVAX Immunogenicity in Orthopedic Implant Patients - Full Text View

Sponsored by:	Nabi Biopharmaceuticals
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00211926

Purpose

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.

Condition	Intervention	Phase
Staphylococcal Infections Joint Prosthesis	Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate Biological: placebo	Phase III

MedlinePlus related topics: Staphylococcal Infections

U.S. FDA Resources

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 Orthopaedic Prosthetic Implant

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

serotype-specific antibody concentrations [ Time Frame: several other time points after dose, up to 365 days ] [ Designated as safety issue: No ]
safety: adverse events [ Time Frame: 0-365 days ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	December 2004
Study Completion Date:	October 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
StaphVAX: Experimental	Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate single dose of vaccine containing 100 mcg of each serotype conjugate
Placebo: Placebo Comparator	Biological: placebo single dose of placebo

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 stage prostate cancer)
Hypersensitivity to components of StaphVAX

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211926

Locations

United States, Virginia
Cllinical Research Asociates of Tidewater
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Nabi Biopharmaceuticals

Investigators

Study Director:

Preston Holley, MD

Nabi Biopharmaceuticals

More Information

Responsible Party:	Nabi Biopharmaceuticals ( Matt Hohenboken, MD, PhD/ Executive Director Clinical and Medical Affairs )
Study ID Numbers:	Nabi-1365
Study First Received:	September 13, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00211926
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:

vaccine
Staphylococcus aureus vaccine

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009