StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

Staphylococcal Infections 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 Receiving an Orthopedic Prosthetic Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211965
• Other study ID #: Nabi-1363
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 26, 2007
• Start date: April 2005
• Est. completion date: August 2006

Study information

• Verified date: December 2007
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

• Staphylococcal Infections

Intervention

Biological:
• S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
single IM dose of 200 mcg total conjugate
• placebo
single dose IM

Locations

Country	Name	City	State
United Kingdom	National Royal Orthopaedic Hospital	Stanmore	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals	Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sero-type specific antibody concentrations		6 weeks after study dose	No
Secondary	Sero-type specific antibody concentrations		various other time points after study dose, up to 26 wk	No
Secondary	adverse events		throughout 6 months observation after study dose	Yes