StaphVAX in Cardiovascular Surgery Patients

Nabi Biopharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Staphylococcal Infections

Cardiovascular Diseases

Cardiovascular Surgical Procedures

Treatments

Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Biological: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00211913

Nabi-1366

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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