Staphylococcal InfectionsPhase 3NCT00211965
StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
A Phase 3 study testing S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate in people with Staphylococcal Infections, run by Nabi Biopharmaceuticals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Candidate for knee or hip replacement
- Expectation of protocol compliance
- Negative pregnancy test, where appropriate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Royal Orthopaedic Hospital
Stanmore, Middlesex, HA7 4LP
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adult Patients Receiving an Orthopedic Prosthetic Implant
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.
- Conditions
- Staphylococcal Infections
- Being tested
- S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate, placebo
- Keywords
- Knee replacement surgery, hip replacement surgery, nosocomial infections, Arthroplasty
- Medical subject headings
- Staphylococcal Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. aureus Types 5 and 8 Capsular Polysaccharide ConjugateBiological
Also called StaphVAX®
single IM dose of 200 mcg total conjugate
placeboBiological
single dose IM
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Experimental | single dose Receives: Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate |
| placebo | Placebo comparator | single dose Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sero-type specific antibody concentrations
Measured: 6 weeks after study dose
Secondary outcomes (2)
Sero-type specific antibody concentrations
Measured: various other time points after study dose, up to 26 wk
adverse events
Measured: throughout 6 months observation after study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMay 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Public Health England
- Investigators
- Matt Hohenboken, MD, PhD, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211965
- Sponsor's protocol ID
- Nabi-1363
- Status last verified
- Dec 2007
- First submitted
- 13 Sep 2005
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adult Patients Receiving an Orthopedic Prosthetic Implant
- ClinicalTrials.gov ID
- NCT00211965
- Acronym / sponsor ID
- Nabi-1363
- Conditions
- Staphylococcal Infections
- Keywords
- Knee replacement surgery, hip replacement surgery, nosocomial infections, Arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Public Health England
- Study start
- Apr 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccine | Experimental | Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugatesingle dose |
| placebo | Placebo comparator | Biological: placebosingle dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Candidate for knee or hip replacement
- Expectation of protocol compliance
- Negative pregnancy test, where appropriate
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S. aureus Types 5 and 8 Capsular Polysaccharide ConjugateAlso: StaphVAX®single IM dose of 200 mcg total conjugate | Biological | vaccine |
| placebosingle dose IM | Biological | placebo |
Primary outcome
Sero-type specific antibody concentrations
Time frame: 6 weeks after study dose
2 secondary outcomes
Sero-type specific antibody concentrations
Time frame: various other time points after study dose, up to 26 wk
adverse events
Time frame: throughout 6 months observation after study dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Hohenboken, MD, PhD study director
Nabi Biopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate in people with Staphylococcal Infections, run by Nabi Biopharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sero-type specific antibody concentrations (time frame: 6 weeks after study dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2008.