NCT00211965

Brief Summary

Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for orthopedic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 4, 2008

Status Verified

December 1, 2007

Enrollment Period

1.1 years

First QC Date

September 13, 2005

Last Update Submit

December 26, 2007

Conditions

Staphylococcal Infections

Keywords

Knee replacement surgeryhip replacement surgerynosocomial infectionsArthroplasty

Outcome Measures

Primary Outcomes (1)

  • Sero-type specific antibody concentrations

    6 weeks after study dose

Secondary Outcomes (2)

  • Sero-type specific antibody concentrations

    various other time points after study dose, up to 26 wk

  • adverse events

    throughout 6 months observation after study dose

Study Arms (2)

vaccine

EXPERIMENTAL

single dose

Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate

placebo

PLACEBO COMPARATOR

single dose

Biological: placebo

Interventions

S. aureus Types 5 and 8 Capsular Polysaccharide ConjugateBIOLOGICAL

single IM dose of 200 mcg total conjugate

Also known as: StaphVAX®
vaccine
placeboBIOLOGICAL

single dose IM

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 prostate cancer)
  • Hypersensitivity to components of StaphVAX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Royal Orthopaedic Hospital

Stanmore, Middlesex, HA7 4LP, United Kingdom

Location

MeSH Terms

Conditions

Staphylococcal InfectionsCross Infection

Interventions

StaphVax

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsIatrogenic 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

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2005

Primary Completion

May 1, 2006

Study Completion

August 1, 2006

Last Updated

January 4, 2008

Record last verified: 2007-12

Locations

GB(1)