StaphVAX Immunogenicity in Orthopedic Implant Patients

Nabi Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Staphylococcal Infections; Joint Prosthesis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00211926

Nabi-1365

Details and patient eligibility

About

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.

Enrollment: 120 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 stage prostate cancer)
• Hypersensitivity to components of StaphVAX

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

StaphVAX

Experimental group

Treatment:

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

Placebo

Placebo Comparator group

Treatment:

Biological: placebo