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:
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00130260
First received: August 12, 2005
Last updated: December 26, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serotype-specific antibody concentrations [ Time Frame: at several other time points up to 12 months after dose ] [ Designated as safety issue: No ]
  • elicited vaccine reactogenicity [ Time Frame: daily for 7 days after each dose ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: August 12, 2005
Last Updated: December 26, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014