Staphylococcal InfectionsPhase 3NCT00211913
StaphVAX in Cardiovascular Surgery Patients
A Phase 3 study testing S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate in people with Staphylococcal Infections and Cardiovascular Diseases, run by Nabi Biopharmaceuticals at 1 site in United States.
Trial summary
S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) 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, Cardiovascular Diseases, Cardiovascular Surgical Procedures
- What is being tested?
- S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jan 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
- Candidate for cardiovascular surgery
- Expected to comply with protocol
- Negative pregnancy test where appropriate
- Written informed consent
Who cannot join
- Known S. aureus infection in past 3 months
- Known infection in the past 2 weeks
- Known HIV infection
- Pregnancy or breast-feeding
- Immunomodulatory drugs
- Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
- investigational drugs, vaccines or products in the past 30 days
- Hypersensitivity to components of StaphVAX
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
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 Undergoing Cardiovascular Surgery
- aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) 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 during 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 cardiovascular surgery.
- Being tested
- S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate, placebo
- Medical subject headings
- Staphylococcal Infections, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. aureus Type 5 & 8 Capsular Polysaccharide ConjugateBiological
Also called StaphVAX®
single IM dose totalling 200 mcg of conjugate
placeboBiological
single IM dose
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Experimental | single dose of StaphVAX® Receives: Biological: S. aureus Type 5 & 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.
Serotype-specific antibody concentrations
Measured: 6 weeks after the vaccine dose
Secondary outcomes (2)
Serotype-specific antibody concentrations
Measured: at other time points 7-180 days after the vaccine dose.
adverse events
Measured: 0-180 days after vaccine 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 startJun 2004
- Primary completionOct 2005
- Study completionJan 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Preston Holley, MD, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211913
- Sponsor's protocol ID
- Nabi-1366
- 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 Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT00211913
- Acronym / sponsor ID
- Nabi-1366
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Jan 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.
- aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) 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 during 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 cardiovascular 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 Type 5 & 8 Capsular Polysaccharide Conjugatesingle dose of StaphVAX® |
| 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)
- Candidate for cardiovascular surgery
- Expected to comply with protocol
- Negative pregnancy test where appropriate
- Written informed consent
Key exclusion criteria (8 listed)
- Known S. aureus infection in past 3 months
- Known infection in the past 2 weeks
- Known HIV infection
- Pregnancy or breast-feeding
- Immunomodulatory drugs
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 Type 5 & 8 Capsular Polysaccharide ConjugateAlso: StaphVAX®single IM dose totalling 200 mcg of conjugate | Biological | vaccine |
| placebosingle IM dose | Biological | placebo |
Primary outcome
Serotype-specific antibody concentrations
Time frame: 6 weeks after the vaccine dose
2 secondary outcomes
Serotype-specific antibody concentrations
Time frame: at other time points 7-180 days after the vaccine dose.
adverse events
Time frame: 0-180 days after vaccine 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.
Preston Holley, MD 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 Type 5 & 8 Capsular Polysaccharide Conjugate in people with Staphylococcal Infections and Cardiovascular Diseases, run by Nabi Biopharmaceuticals at 1 site in United States.
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 8 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 States. 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?
Serotype-specific antibody concentrations (time frame: 6 weeks after the vaccine 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.