NCT00211926

Brief Summary

S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 4, 2008

Status Verified

December 1, 2007

Enrollment Period

1.5 years

First QC Date

September 13, 2005

Last Update Submit

December 21, 2007

Conditions

Staphylococcal InfectionsJoint Prosthesis

Keywords

vaccineStaphylococcus aureus vaccine

Outcome Measures

Primary Outcomes (1)

  • serotype-specific antibody concentrations

    6 weeks after dose

Secondary Outcomes (2)

  • serotype-specific antibody concentrations

    several other time points after dose, up to 365 days

  • safety: adverse events

    0-365 days

Study Arms (2)

StaphVAX

EXPERIMENTAL
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Placebo

PLACEBO COMPARATOR
Biological: placebo

Interventions

S. aureus Type 5 & 8 Capsular Polysaccharide ConjugateBIOLOGICAL

single dose of vaccine containing 100 mcg of each serotype conjugate

StaphVAX
placeboBIOLOGICAL

single dose of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • age 18 years or older
  • candidate for knee or hip replacement
  • expectation of protocol compliance
  • negative pregnancy test, where appropriate

You may not qualify if:

  • known S. aureus infection in the prior 3 months
  • infection in the prior 2 weeks
  • Known HIV infection
  • immunomodulatory drugs
  • Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
  • Hypersensitivity to components of StaphVAX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cllinical Research Asociates of Tidewater

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Preston Holley, MD

    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

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2004

Primary Completion

June 1, 2006

Study Completion

October 1, 2006

Last Updated

January 4, 2008

Record last verified: 2007-12

Locations

US(1)