StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

NCT ID: NCT00211965

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Staphylococcal Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vaccine

single dose

Group Type EXPERIMENTAL

S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate

Intervention Type BIOLOGICAL

single IM dose of 200 mcg total conjugate

placebo

single dose

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

single dose IM

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate

single IM dose of 200 mcg total conjugate

Intervention Type BIOLOGICAL

placebo

single dose IM

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

StaphVAX®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 years or older
* Candidate for knee or hip replacement
* Expectation of protocol compliance
* Negative pregnancy test, where appropriate

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Public Health England

OTHER_GOV

Sponsor Role collaborator

Nabi Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nabi Biopharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matt Hohenboken, MD, PhD

Role: STUDY_DIRECTOR

Nabi Biopharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Royal Orthopaedic Hospital

Stanmore, Middlesex, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Nabi-1363

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase I STEBVax in Healthy Adults
NCT00974935 COMPLETED PHASE1