Staphylococcal InfectionsPhase 3SHIELD-2NCT00130260
Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease
A Phase 3 study testing Staph aureus types 5 and 8 conjugate vaccine in people with Staphylococcal Infections and Chronic Kidney Failure, run by Nabi Biopharmaceuticals at 1 site in United States.
Trial summary
This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. 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?
- Staph aureus types 5 and 8 conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in prior study Nabi-1371
- Written informed consent
- Negative serum pregnancy test, where appropriate
- 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 2 months prior to injection
- Hypersensitivity to components of StaphVAX
Trial locations and contacts
1 site in 1 country.
United States1 site
multiple sites: contact Central Study coordination
Birmingham, Alabama
About this study
Official title: Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease
This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.
- Conditions
- Staphylococcal Infections, Chronic Kidney Failure
- Being tested
- Staph aureus types 5 and 8 conjugate vaccine, placebo
- Keywords
- Staphylococcus aureus, Vaccine, Randomized Controlled Trial
- 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.
Staph aureus types 5 and 8 conjugate vaccineBiological
Also called StaphVAX®
each IM dose contains 200 mc total conjugate
placeboBiological
placebo to match StaphVAX
| Study group | Role | What they receive |
|---|---|---|
| vaccine, schedule 1 | Experimental | 3rd and 4th dose of vaccine, on original schedule Receives: Biological: Staph aureus types 5 and 8 conjugate vaccine |
| vaccine, schedule 2 | Experimental | 3rd and 4th dose of vaccine on modified schedule Receives: Biological: Staph aureus types 5 and 8 conjugate vaccine |
| placebo, schedule 1 | Placebo comparator | 3rd and 4th dose of placebo, on original schedule Receives: Biological: placebo |
| placebo, schedule 2 | Placebo comparator | 3rd and 4th dose of placebo on modified schedule 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 each dose
Secondary outcomes (2)
serotype-specific antibody concentrations
Measured: at several other time points up to 12 months after dose
elicited vaccine reactogenicity
Measured: daily for 7 days after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2005
- Study completionApr 2006
Why it stopped: unsatisfactory efficacy data from preceding trial
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
- 99 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
- NCT00130260
- Sponsor's protocol ID
- Nabi-1372
- Acronym
- SHIELD-2
- Status last verified
- Dec 2007
- First submitted
- 12 Aug 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
- Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00130260
- Acronym / sponsor ID
- SHIELD-2 / Nabi-1372
- Conditions
- Staphylococcal Infections, Chronic Kidney Failure
- Keywords
- Staphylococcus aureus, Vaccine, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unsatisfactory efficacy data from preceding trial
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 15 Aug 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 is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vaccine, schedule 1 | Experimental | Biological: Staph aureus types 5 and 8 conjugate vaccine3rd and 4th dose of vaccine, on original schedule |
| vaccine, schedule 2 | Experimental | Biological: Staph aureus types 5 and 8 conjugate vaccine3rd and 4th dose of vaccine on modified schedule |
| placebo, schedule 1 | Placebo comparator | Biological: placebo3rd and 4th dose of placebo, on original schedule |
| placebo, schedule 2 | Placebo comparator | Biological: placebo3rd and 4th dose of placebo on modified schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participation in prior study Nabi-1371
- Written informed consent
- Negative serum pregnancy test, where appropriate
- Expect to comply with protocol procedures and schedule
Key exclusion criteria (6 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 2 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 |
|---|---|---|
| Staph aureus types 5 and 8 conjugate vaccineAlso: StaphVAX®each IM dose contains 200 mc total conjugate | Biological | vaccine, schedule 1, vaccine, schedule 2 |
| placeboplacebo to match StaphVAX | Biological | placebo, schedule 1, placebo, schedule 2 |
Primary outcome
serotype-specific antibody concentrations
Time frame: 6 weeks after each dose
2 secondary outcomes
serotype-specific antibody concentrations
Time frame: at several other time points up to 12 months after dose
elicited vaccine reactogenicity
Time frame: daily for 7 days after each dose
Results and safety
The study was stopped early (reason given: unsatisfactory efficacy data from preceding trial). Results are not available in the source record.
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 Staph aureus types 5 and 8 conjugate 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 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: stopped early, 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 was stopped early (reason given: unsatisfactory efficacy data from preceding trial). Results are not available in the source record.
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 each 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.