NCT00130260

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 4, 2008

Status Verified

December 1, 2007

Enrollment Period

4 months

First QC Date

August 12, 2005

Last Update Submit

December 26, 2007

Conditions

Staphylococcal InfectionsChronic Kidney Failure

Keywords

Staphylococcus aureusVaccineRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • serotype-specific antibody concentrations

    6 weeks after each dose

Secondary Outcomes (2)

  • serotype-specific antibody concentrations

    at several other time points up to 12 months after dose

  • elicited vaccine reactogenicity

    daily for 7 days after each dose

Study Arms (4)

vaccine, schedule 1

EXPERIMENTAL

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

Biological: Staph aureus types 5 and 8 conjugate vaccine

vaccine, schedule 2

EXPERIMENTAL

3rd and 4th dose of vaccine on modified schedule

Biological: Staph aureus types 5 and 8 conjugate vaccine

placebo, schedule 1

PLACEBO COMPARATOR

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

Biological: placebo

placebo, schedule 2

PLACEBO COMPARATOR

3rd and 4th dose of placebo on modified schedule

Biological: placebo

Interventions

Staph aureus types 5 and 8 conjugate vaccineBIOLOGICAL

each IM dose contains 200 mc total conjugate

Also known as: StaphVAX®
vaccine, schedule 1vaccine, schedule 2
placeboBIOLOGICAL

placebo to match StaphVAX

placebo, schedule 1placebo, schedule 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in prior study Nabi-1371
  • Written informed consent
  • Negative serum pregnancy test, where appropriate
  • Expect to comply with protocol procedures and schedule

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

multiple sites: contact Central Study coordination

Birmingham, Alabama, United States

Location

MeSH Terms

Conditions

Staphylococcal InfectionsKidney Failure, Chronic

Interventions

StaphVax

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matt Hohenboken, MD, PhD

    Nabi Biopharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

August 1, 2005

Primary Completion

December 1, 2005

Study Completion

April 1, 2006

Last Updated

January 4, 2008

Record last verified: 2007-12

Locations

US(1)