StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

Nabi Biopharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Staphylococcal Infections

Treatments

Biological: placebo

Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00211965

Nabi-1363

Details and patient eligibility

About

Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides 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 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 orthopedic surgery.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18 years or older
Candidate for knee or hip replacement
Expectation of protocol compliance
Negative pregnancy test, where appropriate

Exclusion criteria

Known S. aureus infection in the prior 3 months
Infection in the prior 2 weeks
Known HIV infection
Immunomodulatory drugs
Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early prostate cancer)
Hypersensitivity to components of StaphVAX