StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adult Patients Receiving an Orthopedic Prosthetic Implant

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00211965

Enrollment

Registered

2005-09-21

Start date

2005-04-30

Completion date

2006-08-31

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

Staphylococcal Infections

Keywords

Knee replacement surgery, hip replacement surgery, nosocomial infections, Arthroplasty

Brief summary

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.

Interventions

BIOLOGICALS. aureus Types 5 and 8 Capsular Polysaccharide Conjugate

single IM dose of 200 mcg total conjugate

BIOLOGICALplacebo

single dose IM

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

* 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

Design outcomes

Primary

Measure	Time frame
Sero-type specific antibody concentrations	6 weeks after study dose

Secondary

Measure	Time frame
Sero-type specific antibody concentrations	various other time points after study dose, up to 26 wk
adverse events	throughout 6 months observation after study dose

Countries

United Kingdom

Outcome results

None listed

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