StaphVAX in Cardiovascular Surgery Patients - Full Text View

Sponsored by:	Nabi Biopharmaceuticals
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00211913

Purpose

S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) 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 during 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 cardiovascular surgery.

Condition	Intervention	Phase
Staphylococcal Infections Cardiovascular Diseases Cardiovascular Surgical Procedures	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 Undergoing Cardiovascular Surgery

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Serotype-specific antibody concentrations [ Time Frame: at other time points 7-180 days after the vaccine dose. ] [ Designated as safety issue: No ]
adverse events [ Time Frame: 0-180 days after vaccine dose ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	June 2004
Study Completion Date:	January 2006
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
vaccine: Experimental single dose of StaphVAX®	Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate single IM dose totalling 200 mcg of conjugate
placebo: Placebo Comparator single dose	Biological: placebo single IM dose

Eligibility

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

Criteria

Inclusion Criteria:

Candidate for cardiovascular surgery
Expected to comply with protocol
Negative pregnancy test where appropriate
Written informed consent

Exclusion Criteria:

Known S. aureus infection in past 3 months
Known infection in the past 2 weeks
Known HIV infection
Pregnancy or breast-feeding
Immunomodulatory drugs
Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
investigational drugs, vaccines or products in the past 30 days
Hypersensitivity to components of StaphVAX

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211913

Locations

United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Nabi Biopharmaceuticals

Investigators

Study Director:

Preston Holley, MD

Nabi Biopharmaceuticals

More Information

Responsible Party:	Nai Biopharmaceuticals ( Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs )
Study ID Numbers:	Nabi-1366
Study First Received:	September 13, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00211913
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections

Additional relevant MeSH terms:

Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009