Staphylococcal InfectionsPhase 3NCT00211900
Evaluation of Manufacturing Lot of StaphVAX
A Phase 3 study testing S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine in people with Staphylococcal Infections and Chronic Kidney Failure, run by Nabi Biopharmaceuticals at 1 site in United States.
Trial summary
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections, Chronic Kidney Failure
- What is being tested?
- S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Nov 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
- 8 wk of hemodialysis for ESRD,
- have written informed consent,
- a negative serum pregnancy test if appropriate,
- and expect to comply with protocol procedures and schedule
Who cannot join
- known HIV,
- immunomodulatory drugs,
- malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
- active infection in the 2 weeks prior to study injection,
- serious S. aureus infection within the last 3 months prior to injection,
- use of investigational drugs, vaccines or devices within the prior 30 days,
- hypersensitivity to components of StaphVAX
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.
- Conditions
- Staphylococcal Infections, Chronic Kidney Failure
- Being tested
- S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
- 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 & 8 Capsular Polysaccharide VaccineBiological
Also called StaphVAX®
single IM dose totalling 200 mcg of conjugate
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Experimental | single dose of StaphVAX in hemodialysis patients Receives: Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type-specific antibody concentrations
Measured: 6 weeks after vaccine dose
Secondary outcomes (2)
Type-specific antibody concentrations
Measured: 3 weeks after vaccine dose
Elicited vaccine reactogenicity.
Measured: daily for 7 days after 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 startMar 2005
- Primary completionAug 2005
- Study completionNov 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
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
- NCT00211900
- Sponsor's protocol ID
- Nabi-1367
- 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 Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
- ClinicalTrials.gov ID
- NCT00211900
- Acronym / sponsor ID
- Nabi-1367
- Conditions
- Staphylococcal Infections, Chronic Kidney Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Nov 2005 (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.
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccine | Experimental | Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccinesingle dose of StaphVAX in hemodialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 8 wk of hemodialysis for ESRD,
- have written informed consent,
- a negative serum pregnancy test if appropriate,
- and expect to comply with protocol procedures and schedule
Key exclusion criteria (7 listed)
- known HIV,
- immunomodulatory drugs,
- malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
- active infection in the 2 weeks prior to study injection,
- serious S. aureus infection within the last 3 months prior to injection,
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 VaccineAlso: StaphVAX®single IM dose totalling 200 mcg of conjugate | Biological | vaccine |
Primary outcome
Type-specific antibody concentrations
Time frame: 6 weeks after vaccine dose
2 secondary outcomes
Type-specific antibody concentrations
Time frame: 3 weeks after vaccine dose
Elicited vaccine reactogenicity.
Time frame: daily for 7 days after 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 Type 5 & 8 Capsular Polysaccharide Vaccine in people with Staphylococcal Infections and Chronic Kidney Failure, 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 7 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. 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?
Type-specific antibody concentrations (time frame: 6 weeks after 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.