StaphVAX in Cardiovascular Surgery Patients

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

placebo

About this trial

This is an interventional prevention trial for Staphylococcal Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Research Associates of Tidewater

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vaccine

placebo

Arm Description

single dose of StaphVAX®

single dose

Outcomes

Primary Outcome Measures

Serotype-specific antibody concentrations

Secondary Outcome Measures

Serotype-specific antibody concentrations

adverse events

Full Information

NCT ID

NCT00211913

First Posted

September 13, 2005

Last Updated

December 26, 2007

Sponsor

Nabi Biopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00211913

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nabi Biopharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcal Infections, Cardiovascular Diseases, Cardiovascular Surgical Procedures

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vaccine

Arm Type

Experimental

Arm Description

single dose of StaphVAX®

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

single dose

Intervention Type

Biological

Intervention Name(s)

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Other Intervention Name(s)

StaphVAX®

Intervention Description

single IM dose totalling 200 mcg of conjugate

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

single IM dose

Primary Outcome Measure Information:

Title

Serotype-specific antibody concentrations

Time Frame

6 weeks after the vaccine dose

Secondary Outcome Measure Information:

Title

Serotype-specific antibody concentrations

Time Frame

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

Title

adverse events

Time Frame

0-180 days after vaccine dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Preston Holley, MD

Organizational Affiliation

Nabi Biopharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research Associates of Tidewater

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Staphylococcal Infections, Cardiovascular Diseases, Cardiovascular Surgical Procedures

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial