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

December 26, 2007 updated by: Nabi Biopharmaceuticals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • multiple sites: contact Central Study coordination

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serotype-specific antibody concentrations
Time Frame: 6 weeks after each dose
6 weeks after each dose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabi Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

August 12, 2005

First Submitted That Met QC Criteria

August 12, 2005

First Posted (Estimate)

August 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 4, 2008

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nabi-1372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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