Back to resultsEvaluation of Manufacturing Lot of StaphVAX
Primary Purpose
Staphylococcal Infections, Chronic Kidney Failure
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcal Infections
Eligibility Criteria
Inclusion Criteria: 8 wk of hemodialysis for ESRD, have written informed consent, a negative serum pregnancy test if appropriate, and expect to comply with protocol procedures and schedule Exclusion Criteria: known HIV, immunomodulatory drugs, malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer), active infection in the 2 weeks prior to study injection, serious S. aureus infection within the last 3 months prior to injection, use of investigational drugs, vaccines or devices within the prior 30 days, hypersensitivity to components of StaphVAX
Sites / Locations
- Trialogic Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vaccine
Arm Description
single dose of StaphVAX in hemodialysis patients
Outcomes
Primary Outcome Measures
Type-specific antibody concentrations
Secondary Outcome Measures
Type-specific antibody concentrations
Elicited vaccine reactogenicity.
Full Information
NCT ID
NCT00211900
First Posted
September 13, 2005
Last Updated
December 26, 2007
Sponsor
Nabi Biopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00211900
Brief Title
Evaluation of Manufacturing Lot of StaphVAX
Official Title
A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nabi Biopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections, Chronic Kidney Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vaccine
Arm Type
Experimental
Arm Description
single dose of StaphVAX in hemodialysis patients
Intervention Type
Biological
Intervention Name(s)
S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
Other Intervention Name(s)
StaphVAX®
Intervention Description
single IM dose totalling 200 mcg of conjugate
Primary Outcome Measure Information:
Title
Type-specific antibody concentrations
Time Frame
6 weeks after vaccine dose
Secondary Outcome Measure Information:
Title
Type-specific antibody concentrations
Time Frame
3 weeks after vaccine dose
Title
Elicited vaccine reactogenicity.
Time Frame
daily for 7 days after dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
8 wk of hemodialysis for ESRD,
have written informed consent,
a negative serum pregnancy test if appropriate,
and expect to comply with protocol procedures and schedule
Exclusion Criteria:
known HIV,
immunomodulatory drugs,
malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
active infection in the 2 weeks prior to study injection,
serious S. aureus infection within the last 3 months prior to injection,
use of investigational drugs, vaccines or devices within the prior 30 days,
hypersensitivity to components of StaphVAX
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Hohenboken, MD, PhD
Organizational Affiliation
Nabi Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Trialogic Research
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758
Country
United States
12. IPD Sharing Statement
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Evaluation of Manufacturing Lot of StaphVAX
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