Expired Study
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Norfolk, Virginia 23507


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

Nabi-1366


NCT ID:

NCT00211913


Secondary ID:


Study Acronym:


Brief Title:

StaphVAX in Cardiovascular Surgery Patients


Official 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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nabi Biopharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Actual


Overall Contact Information

Official Name:Preston Holley, MD
Study Director
Nabi Biopharmaceuticals

Study Dates

Start Date:June 2004
Completion Date:January 2006
Completion Type:Actual
Primary Completion Date:October 2005
Primary Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 26, 2007
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Serotype-specific antibody concentrations
Time Frame:6 weeks after the vaccine dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Serotype-specific antibody concentrations
Time Frame:at other time points 7-180 days after the vaccine dose.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:adverse events
Time Frame:0-180 days after vaccine dose
Safety Issues:True

Study Interventions

Intervention Type:Biological
Name:S. aureus Type 5 & 8 Capsular Polysaccharide C
Description:single IM dose totalling 200 mcg of conjugate
Arm Name:vaccine
Other Name:StaphVAX®
Intervention Type:Biological
Name:placebo
Description:single IM dose
Arm Name:placebo

Study Arms

Study Arm Type:Experimental
Arm Name:vaccine
Description:single dose of StaphVAX®
Study Arm Type:Placebo Comparator
Arm Name:placebo
Description:single dose

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Nabi Biopharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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