StaphVAX in Cardiovascular Surgery Patients
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
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJanuary 4, 2008
December 1, 2007
1.3 years
September 13, 2005
December 26, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Serotype-specific antibody concentrations
6 weeks after the vaccine dose
Secondary Outcomes (2)
Serotype-specific antibody concentrations
at other time points 7-180 days after the vaccine dose.
adverse events
0-180 days after vaccine dose
Study Arms (2)
vaccine
EXPERIMENTALsingle dose of StaphVAX®
placebo
PLACEBO COMPARATORsingle dose
Interventions
single IM dose totalling 200 mcg of conjugate
Eligibility Criteria
You may qualify if:
- Candidate for cardiovascular surgery
- Expected to comply with protocol
- Negative pregnancy test where appropriate
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Preston Holley, MD
Nabi Biopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
June 1, 2004
Primary Completion
October 1, 2005
Study Completion
January 1, 2006
Last Updated
January 4, 2008
Record last verified: 2007-12