StaphVAX in Cardiovascular Surgery Patients

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211913
• Other study ID #: Nabi-1366
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 26, 2007
• Start date: June 2004
• Est. completion date: January 2006

Study information

• Verified date: December 2007
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Surgical Procedures
• Staphylococcal Infections

Intervention

Biological:
• S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single IM dose totalling 200 mcg of conjugate
• placebo
single IM dose

Locations

Country	Name	City	State
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotype-specific antibody concentrations		6 weeks after the vaccine dose	No
Secondary	Serotype-specific antibody concentrations		at other time points 7-180 days after the vaccine dose.	No
Secondary	adverse events		0-180 days after vaccine dose	Yes