Skip to main content
OpenTrials
Completed

NCT Number: NCT00211926

StaphVAX Immunogenicity in Orthopedic Implant Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Joint Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cllinical Research Asociates of Tidewater

Norfolk, Virginia, 23507, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Biological

single dose of vaccine containing 100 mcg of each serotype conjugate

Placebo

Biological

single dose of placebo

Primary outcomes

  1. serotype-specific antibody concentrations

    Time frame: 6 weeks after dose

Secondary outcomes

  1. serotype-specific antibody concentrations

    Time frame: several other time points after dose, up to 365 days

  2. safety: adverse events

    Time frame: 0-365 days

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Jan 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.