Evaluation of Manufacturing Lot of StaphVAX

This study has been completed.
Sponsor:
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00211900
First received: September 13, 2005
Last updated: December 26, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Type-specific antibody concentrations [ Time Frame: 3 weeks after vaccine dose ] [ Designated as safety issue: No ]
  • Elicited vaccine reactogenicity. [ Time Frame: daily for 7 days after dose ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: December 26, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Staphylococcal Infections
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 26, 2014