Staphylococcal InfectionsPhase 3NCT00071214
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
A Phase 3 study testing S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine in people with Staphylococcal Infections and Kidney Failure, Chronic, run by Nabi Biopharmaceuticals.
Trial summary
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections, Kidney Failure, Chronic
- What is being tested?
- S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
- Type of treatment
- Vaccines
- How many people
- 3,600 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Sep 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Diagnosis of chronic end-stage renal disease with maintenance on hemodialysis continuously for at least eight (8) weeks prior to enrollment.
- Hemodialysis access using native vessel fistula or synthetic/heterologous graft (not catheter).
- Expectation of compliance with protocol procedures, and visit schedule.
- Negative serum pregnancy test in females of child-bearing potential (serum -HCG within 7 days prior to each study drug injection).
- Written informed consent.
Who cannot join
- Known serious S. aureus infection within 3 months of study entry.
- Known recurrent S. aureus infection of the current graft.
- Known active viral or bacterial infection or symptoms/signs consistent with such an infection with the two weeks prior to injection of investigational product. Mild intercurrent viral illness with a temperature of 100.6F or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the vaccine.
- Known HIV infection (testing not required for protocol).
- Known hypersensitivity or previous anaphylaxis to polysaccharides or polysaccharide-conjugate vaccines or to components of such vaccines.
- Known or suspected abuse of any drugs, prescribed or illicit, in the past year.
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- Current use of immunosuppressive or immunomodulatory drugs (including systemic glucocorticoids, chlorambucil, cyclophosphamide, azathioprine, methotrexate, cyclosporine, mycophenolate, human immune globulin in excess of 0.2 g/Kg per month, any monoclonal antibody specific for any human leukocyte subset or cytokine, or any interferon preparation), except low-dose physiologic replacement glucocorticoid therapy (Less than or equal to 10 mg of prednisone or equivalent per day).
- Known malignancy or treatment for malignancy within the past six months, other than basal cell or squamous cell carcinoma of the skin.
- Use of investigational drugs, products, or devices within 30 days prior to vaccine injection.
- Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardized the quality of the data to be generated.
- Previous administration of StaphVAX
About this study
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.
Read the detailed description
Two part clinical trial designed to evaluate the efficacy of StaphVAX in adults on hemodialysis. Part A will evaluate the prevention of bacteremic infections in End Stage Renal Disease (ESRD) patients during the interval between 3 and 35 weeks after a single dose of StaphVAX. Part B of this study is designed to assess immunogenicity of a second [booster] dose of vaccine in patients completing Part A, and the cumulative (Part A + B) efficacy.
- Conditions
- Staphylococcal Infections, Kidney Failure, Chronic
- Being tested
- S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
- Keywords
- Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus, Staphylococcus aureus infection
- Medical subject headings
- Staphylococcal Infections, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate VaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented S. aureus invasive infection, weeks 3-35
Secondary outcomes (4)
Documented S. aureus invasive infection in other time periods
Immunogenicity at mulitple time points
Safety
Health economics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2003 (estimated)
- Study startSep 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 3,600 participants
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matt Hohenboken, MD, PhD, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071214
- Sponsor's protocol ID
- Nabi-1371
- Status last verified
- Jul 2006
- First submitted
- 15 Oct 2003
- Last updated
- 11 Jul 2006
- Results posted
- No
Publications
Fattom A, Matalon A, Buerkert J, Taylor K, Damaso S, Boutriau D. Efficacy profile of a bivalent Staphylococcus aureus glycoconjugated vaccine in adults on hemodialysis: Phase III randomized study. Hum Vaccin Immunother. 2015;11(3):632-41. doi: 10.4161/hv.34414.
PubMed 25483694Li Y, Friedman JY, O'Neal BF, Hohenboken MJ, Griffiths RI, Stryjewski ME, Middleton JP, Schulman KA, Inrig JK, Fowler VG Jr, Reed SD. Outcomes of Staphylococcus aureus infection in hemodialysis-dependent patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):428-34. doi: 10.2215/CJN.03760708. Epub 2008 Dec 31.
PubMed 19118117
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
- ClinicalTrials.gov ID
- NCT00071214
- Acronym / sponsor ID
- Nabi-1371
- Conditions
- Staphylococcal Infections, Kidney Failure, Chronic
- Keywords
- Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus, Staphylococcus aureus infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,600 participants
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Sep 2005
- First posted
- 17 Oct 2003 (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.
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.
Detailed description
Two part clinical trial designed to evaluate the efficacy of StaphVAX in adults on hemodialysis. Part A will evaluate the prevention of bacteremic infections in End Stage Renal Disease (ESRD) patients during the interval between 3 and 35 weeks after a single dose of StaphVAX. Part B of this study is designed to assess immunogenicity of a second [booster] dose of vaccine in patients completing Part A, and the cumulative (Part A + B) efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Diagnosis of chronic end-stage renal disease with maintenance on hemodialysis continuously for at least eight (8) weeks prior to enrollment.
- Hemodialysis access using native vessel fistula or synthetic/heterologous graft (not catheter).
- Expectation of compliance with protocol procedures, and visit schedule.
- Negative serum pregnancy test in females of child-bearing potential (serum -HCG within 7 days prior to each study drug injection).
Key exclusion criteria (11 listed)
- Known serious S. aureus infection within 3 months of study entry.
- Known recurrent S. aureus infection of the current graft.
- Known active viral or bacterial infection or symptoms/signs consistent with such an infection with the two weeks prior to injection of investigational product. Mild intercurrent viral illness with a temperature of 100.6F or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the vaccine.
- Known HIV infection (testing not required for protocol).
- Known hypersensitivity or previous anaphylaxis to polysaccharides or polysaccharide-conjugate vaccines or to components of such vaccines.
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 and 8 Capsular Polysaccharide Conjugate Vaccine | Biological | – |
Primary outcome
Documented S. aureus invasive infection, weeks 3-35
4 secondary outcomes
Documented S. aureus invasive infection in other time periods
Immunogenicity at mulitple time points
Safety
Health economics
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 11 Jul 2006.
- Derived from this study: PubMed 25483694Fattom A, Matalon A, Buerkert J, Taylor K, Damaso S, Boutriau D. Efficacy profile of a bivalent Staphylococcus aureus glycoconjugated vaccine in adults on hemodialysis: Phase III randomized study. Hum Vaccin Immunother. 2015;11(3):632-41. doi: 10.4161/hv.34414.
- Derived from this study: PubMed 19118117Li Y, Friedman JY, O'Neal BF, Hohenboken MJ, Griffiths RI, Stryjewski ME, Middleton JP, Schulman KA, Inrig JK, Fowler VG Jr, Reed SD. Outcomes of Staphylococcus aureus infection in hemodialysis-dependent patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):428-34. doi: 10.2215/CJN.03760708. Epub 2008 Dec 31.
- Nabi BiopharmaceuticalsLink provided by the sponsor.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine in people with Staphylococcal Infections and Kidney Failure, Chronic, run by Nabi Biopharmaceuticals.
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 6 inclusion and 11 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 11 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Documented S. aureus invasive infection, weeks 3-35. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071214, which also lists 2 linked publications.
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 11 Jul 2006.