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

NCT ID: NCT00130260

Last Updated: 2008-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcal Infections Chronic Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vaccine, schedule 1

3rd and 4th dose of vaccine, on original schedule

Group Type EXPERIMENTAL

Staph aureus types 5 and 8 conjugate vaccine

Intervention Type BIOLOGICAL

each IM dose contains 200 mc total conjugate

vaccine, schedule 2

3rd and 4th dose of vaccine on modified schedule

Group Type EXPERIMENTAL

Staph aureus types 5 and 8 conjugate vaccine

Intervention Type BIOLOGICAL

each IM dose contains 200 mc total conjugate

placebo, schedule 1

3rd and 4th dose of placebo, on original schedule

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

placebo to match StaphVAX

placebo, schedule 2

3rd and 4th dose of placebo on modified schedule

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

placebo to match StaphVAX

Interventions

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Staph aureus types 5 and 8 conjugate vaccine

each IM dose contains 200 mc total conjugate

Intervention Type BIOLOGICAL

placebo

placebo to match StaphVAX

Intervention Type BIOLOGICAL

Other Intervention Names

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StaphVAX®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nabi Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Nabi Biopharmaceuticals

Principal Investigators

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Matt Hohenboken, MD, PhD

Role: STUDY_DIRECTOR

Nabi Biopharmaceuticals

Locations

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multiple sites: contact Central Study coordination

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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Nabi-1372

Identifier Type: -

Identifier Source: org_study_id

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