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

August 12, 2005
December 26, 2007
August 2005
December 2005   (final data collection date for primary outcome measure)
serotype-specific antibody concentrations [ Time Frame: 6 weeks after each dose ] [ Designated as safety issue: No ]
serotype-specific antibody concentrations 6 weeks after dose
Complete list of historical versions of study NCT00130260 on ClinicalTrials.gov Archive Site
  • 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 ]
  • serotype-specific antibody concentrations at several other time points after dose
  • safety
Not Provided
Not Provided
 
Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Staphylococcal Infections
  • Chronic Kidney Failure
  • Biological: Staph aureus types 5 and 8 conjugate vaccine
    each IM dose contains 200 mc total conjugate
    Other Name: StaphVAX®
  • Biological: placebo
    placebo to match StaphVAX
  • Experimental: vaccine, schedule 1
    3rd and 4th dose of vaccine, on original schedule
    Intervention: Biological: Staph aureus types 5 and 8 conjugate vaccine
  • Experimental: vaccine, schedule 2
    3rd and 4th dose of vaccine on modified schedule
    Intervention: Biological: Staph aureus types 5 and 8 conjugate vaccine
  • Placebo Comparator: placebo, schedule 1
    3rd and 4th dose of placebo, on original schedule
    Intervention: Biological: placebo
  • Placebo Comparator: placebo, schedule 2
    3rd and 4th dose of placebo on modified schedule
    Intervention: Biological: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
99
April 2006
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00130260
Nabi-1372
No
Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
Not Provided
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP