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Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease (SHIELD-2)

This study has been terminated.
(unsatisfactory efficacy data from preceding trial)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130260
First Posted: August 15, 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 is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.

Condition Intervention Phase
Staphylococcal Infections Chronic Kidney Failure Biological: Staph aureus types 5 and 8 conjugate vaccine Biological: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

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

Secondary Outcome Measures:
  • serotype-specific antibody concentrations [ Time Frame: at several other time points up to 12 months after dose ]
  • elicited vaccine reactogenicity [ Time Frame: daily for 7 days after each dose ]

Enrollment: 99
Study Start Date: August 2005
Study Completion Date: April 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccine, schedule 1
3rd and 4th dose of vaccine, on original schedule
Biological: Staph aureus types 5 and 8 conjugate vaccine
each IM dose contains 200 mc total conjugate
Other Name: StaphVAX®
Experimental: vaccine, schedule 2
3rd and 4th dose of vaccine on modified schedule
Biological: Staph aureus types 5 and 8 conjugate vaccine
each IM dose contains 200 mc total conjugate
Other Name: StaphVAX®
Placebo Comparator: placebo, schedule 1
3rd and 4th dose of placebo, on original schedule
Biological: placebo
placebo to match StaphVAX
Placebo Comparator: placebo, schedule 2
3rd and 4th dose of placebo on modified schedule
Biological: placebo
placebo to match StaphVAX

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in prior study Nabi-1371
  • Written informed consent
  • Negative serum pregnancy test, where appropriate
  • 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 2 months prior to injection
  • 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): NCT00130260


Locations
United States, Alabama
multiple sites: contact Central Study coordination
Birmingham, Alabama, United States
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: NCT00130260     History of Changes
Other Study ID Numbers: Nabi-1372
First Submitted: August 12, 2005
First Posted: August 15, 2005
Last Update Posted: January 4, 2008
Last Verified: December 2007

Keywords provided by Nabi Biopharmaceuticals:
Staphylococcus aureus
Vaccine
Randomized Controlled Trial

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