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Completed

NCT Number: NCT00211913

StaphVAX in Cardiovascular Surgery Patients

S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) 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 during 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 cardiovascular surgery.

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Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Cardiovascular Surgical Procedures Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Associates 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

  • Candidate for cardiovascular surgery
  • Expected to comply with protocol
  • Negative pregnancy test where appropriate
  • Written informed consent

Exclusion criteria

  • Known S. aureus infection in past 3 months
  • Known infection in the past 2 weeks
  • Known HIV infection
  • Pregnancy or breast-feeding
  • Immunomodulatory drugs
  • Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
  • investigational drugs, vaccines or products in the past 30 days
  • Hypersensitivity to components of StaphVAX

Treatment and study plan

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Biological

single IM dose totalling 200 mcg of conjugate

Other names: StaphVAX®

Placebo

Biological

single IM dose

Primary outcomes

  1. Serotype-specific antibody concentrations

    Time frame: 6 weeks after the vaccine dose

Secondary outcomes

  1. Serotype-specific antibody concentrations

    Time frame: at other time points 7-180 days after the vaccine dose.

  2. adverse events

    Time frame: 0-180 days after vaccine dose

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 Undergoing Cardiovascular Surgery

Important dates

Study start
2004
Primary completion
2005
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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