StaphVAX in Cardiovascular Surgery Patients | NCT00211913

Studies
StaphVAX in Cardiovascular Surgery Patients

NCT00211913

Sponsor

Nabi Biopharmaceuticals

Status

Completed

Last Update Posted

Jan 4, 2008Estimated

Enrollment

120Actual

Phase

Phase 3

Conditions

Staphylococcal Infections
Cardiovascular Diseases
Cardiovascular Surgical Procedures

Interventions

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Oct 2005Actual

Completion Date

Jan 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2007

Last Update Posted Date

Jan 4, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vaccine	Experimental	single dose of StaphVAX®	Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
placebo	Placebo Comparator	single dose	Biological: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate	Biological	single IM dose totalling 200 mcg of conjugate	vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serotype-specific antibody concentrations		6 weeks after the vaccine dose

Secondary Outcomes

Measure	Description	Time Frame
Serotype-specific antibody concentrations		at other time points 7-180 days after the vaccine dose.
adverse events		0-180 days after vaccine dose

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Preston Holley, MD	Nabi Biopharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Associates of Tidewater		Norfolk	Virginia	23507	United States

Condition Browse Module

MeSH Terms

ID	Term
D013203	Staphylococcal Infections
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C423263	StaphVax

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided