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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00211913

Enrollment

120

Registered

2005-09-21

Start date

2004-06-30

Completion date

2006-01-31

Last updated

2008-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Surgical Procedures, Staphylococcal Infections

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.

Interventions

BIOLOGICALS. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

single IM dose totalling 200 mcg of conjugate

BIOLOGICALplacebo

single IM dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Serotype-specific antibody concentrations	6 weeks after the vaccine dose

Secondary

Measure	Time frame
Serotype-specific antibody concentrations	at other time points 7-180 days after the vaccine dose.
adverse events	0-180 days after vaccine dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026