StaphVAX in Cardiovascular Surgery Patients

This study has been completed.
Sponsor:
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00211913
First received: September 13, 2005
Last updated: December 26, 2007
Last verified: December 2007
  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 3

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

Resource links provided by NLM:


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
Experimental: vaccine
single dose of StaphVAX®
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single IM dose totalling 200 mcg of conjugate
Other Name: StaphVAX®
Placebo Comparator: placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014