StaphVAX Immunogenicity in Orthopedic Implant Patients

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 Orthopaedic Prosthetic Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211926
• Other study ID #: Nabi-1365
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 21, 2007
• Start date: December 2004
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2006
• Est. primary completion date: June 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 stage 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

• Joint Prosthesis
• Staphylococcal Infections

Intervention

Biological:
• S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single dose of vaccine containing 100 mcg of each serotype conjugate
• placebo
single dose of placebo

Locations

Country	Name	City	State
United States	Cllinical Research Asociates of Tidewater	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serotype-specific antibody concentrations		6 weeks after dose	No
Secondary	serotype-specific antibody concentrations		several other time points after dose, up to 365 days	No
Secondary	safety: adverse events		0-365 days	Yes