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OpenTrials
Completed

NCT Number: NCT00211965

StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

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.

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Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Positive Bacterial Infections Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Royal Orthopaedic Hospital

Stanmore, Middlesex, HA7 4LP, United Kingdom

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 prostate cancer)
  • Hypersensitivity to components of StaphVAX

Treatment and study plan

S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate

Biological

single IM dose of 200 mcg total conjugate

Other names: StaphVAX®

Placebo

Biological

single dose IM

Primary outcomes

  1. Sero-type specific antibody concentrations

    Time frame: 6 weeks after study dose

Secondary outcomes

  1. Sero-type specific antibody concentrations

    Time frame: various other time points after study dose, up to 26 wk

  2. adverse events

    Time frame: throughout 6 months observation after study dose

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Collaborators

  • Public Health England

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 Orthopedic Prosthetic Implant

Important dates

Study start
2005
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.

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