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Evaluation of Manufacturing Lot of StaphVAX

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211900
First Posted: September 21, 2005
Last Update Posted: January 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nabi Biopharmaceuticals
  Purpose
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.

Condition Intervention Phase
Staphylococcal Infections Chronic Kidney Failure Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Type-specific antibody concentrations [ Time Frame: 6 weeks after vaccine dose ]

Secondary Outcome Measures:
  • Type-specific antibody concentrations [ Time Frame: 3 weeks after vaccine dose ]
  • Elicited vaccine reactogenicity. [ Time Frame: daily for 7 days after dose ]

Enrollment: 65
Study Start Date: March 2005
Study Completion Date: November 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccine
single dose of StaphVAX in hemodialysis patients
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
single IM dose totalling 200 mcg of conjugate
Other Name: StaphVAX®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211900


Locations
United States, Alabama
Trialogic Research
Madison, Alabama, United States, 35758
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
  More Information

Responsible Party: Matt Hohenboken, MD, PhD, Executive Director, Clinical & Medical Affairs, Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00211900     History of Changes
Other Study ID Numbers: Nabi-1367
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: January 4, 2008
Last Verified: December 2007

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Staphylococcal Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs