StaphVAX in Cardiovascular Surgery Patients

NCT ID: NCT00211913

Last Updated: 2008-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcal Infections Cardiovascular Diseases Cardiovascular Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vaccine

single dose of StaphVAX®

Group Type EXPERIMENTAL

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Intervention Type BIOLOGICAL

single IM dose totalling 200 mcg of conjugate

placebo

single dose

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

single IM dose

Interventions

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S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

single IM dose totalling 200 mcg of conjugate

Intervention Type BIOLOGICAL

placebo

single IM dose

Intervention Type BIOLOGICAL

Other Intervention Names

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StaphVAX®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nabi Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Nai Biopharmaceuticals

Principal Investigators

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Preston Holley, MD

Role: STUDY_DIRECTOR

Nabi Biopharmaceuticals

Locations

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Clinical Research Associates of Tidewater

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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Nabi-1366

Identifier Type: -

Identifier Source: org_study_id

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