END STAGE RENAL DISEASEPhase 2NCT01031966
A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine
A Phase 2 study testing MF59 adjuvanted H1N1 influenza monovalent vaccine and Thymosin alpha 1 in people with END STAGE RENAL DISEASE, run by sigma-tau i.f.r. S.p.A. at 1 site in Italy.
Trial summary
The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- END STAGE RENAL DISEASE
- What is being tested?
- MF59 adjuvanted H1N1 influenza monovalent vaccine and Thymosin alpha 1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Jul 2010
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Age > 18 .
- Chronic dialysis for ESRD .
- Life expectancy of at least 6 months.
Who cannot join
- They have any serious disease
- They are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
- They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
- Within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38°C).
- They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Second Division of Nephrology and Dialysis - Padua Hospital
Padua, 35128
About this study
Official title: A Pilot, Randomized, Open-label Study in Patients on Chronic Dialysis With End Stage Renal Disease (Esrd), to Evaluate the Enhancing Effect of Two Doses of Thymosin Alpha 1 on the Immunogenicity of h1n1sw Monovalent Vaccine
The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. The final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of Thymosin alpha 1 in the same indication.
Read the detailed description
The emergence and spread of the novel influenza A (H1N1) virus has been of great concern globally.
Uremic patients are especially vulnerable to infections and it is generally recommended to vaccinate patients with chronic renal insufficiency yearly against influenza. In patients on haemodialysis (HD) the vaccination response has been considered suboptimal.
Decreased antibody response to T-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody responses have also been reported in patients with end-stage renal disease. The evidence for impairment of cell-mediated immunity in hemodialysis patients has been attributed to incompetence in T-cell-mediated immune responses.
Since Zadaxin can enhance T-cell-dependent specific antibody production, the addition of Zadaxin (Thymosin alpha 1)to vaccination programs for immunocompromised individuals should be effective.
- Conditions
- END STAGE RENAL DISEASE
- Being tested
- MF59 adjuvanted H1N1 influenza monovalent vaccine, Thymosin alpha 1
- Keywords
- ESRD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59 adjuvanted H1N1 influenza monovalent vaccineBiological
Also called Focetria™
One/two single administration
Thymosin alpha 1Drug
Also called Zadaxin
1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)
Thymosin alpha 1Drug
Also called Zadaxin
1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)
| Study group | Role | What they receive |
|---|---|---|
| H1N1sw monovalent vaccine | Active comparator | Not described Receives: Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine |
| Thymosin alpha 1 3.2mg | Experimental | Not described Receives: Drug: Thymosin alpha 1 |
| Thymosin alpha 1 6.4 mg | Experimental | Not described Receives: Drug: Thymosin alpha 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measures of immunogenicity, as determined by HI; MN and SRH
Measured: Geometric mean HI titer (GMT) on Day 0, Day 21, Day 42, Day 84 and Day 168 for the primary course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for END STAGE RENAL DISEASEStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- sigma-tau i.f.r. S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agostino Naso, MD, Principal investigator, Second Division of Nephrology and Dialysis - Padua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031966
- Sponsor's protocol ID
- ST1472-DM-09-005
- Status last verified
- Mar 2012
- First submitted
- 11 Dec 2009
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Open-label Study in Patients on Chronic Dialysis With End Stage Renal Disease (Esrd), to Evaluate the Enhancing Effect of Two Doses of Thymosin Alpha 1 on the Immunogenicity of h1n1sw Monovalent Vaccine
- ClinicalTrials.gov ID
- NCT01031966
- Acronym / sponsor ID
- ST1472-DM-09-005
- Conditions
- END STAGE RENAL DISEASE
- Keywords
- ESRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- sigma-tau i.f.r. S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Dec 2009 (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.
The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. The final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of Thymosin alpha 1 in the same indication.
Detailed description
The emergence and spread of the novel influenza A (H1N1) virus has been of great concern globally.
Uremic patients are especially vulnerable to infections and it is generally recommended to vaccinate patients with chronic renal insufficiency yearly against influenza. In patients on haemodialysis (HD) the vaccination response has been considered suboptimal.
Decreased antibody response to T-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody responses have also been reported in patients with end-stage renal disease. The evidence for impairment of cell-mediated immunity in hemodialysis patients has been attributed to incompetence in T-cell-mediated immune responses.
Since Zadaxin can enhance T-cell-dependent specific antibody production, the addition of Zadaxin (Thymosin alpha 1)to vaccination programs for immunocompromised individuals should be effective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H1N1sw monovalent vaccine | Active comparator | Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine |
| Thymosin alpha 1 3.2mg | Experimental | Drug: Thymosin alpha 1 |
| Thymosin alpha 1 6.4 mg | Experimental | Drug: Thymosin alpha 1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent.
- Age > 18 .
- Chronic dialysis for ESRD .
- Life expectancy of at least 6 months.
Key exclusion criteria (5 listed)
- They have any serious disease
- They are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
- They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
- Within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38°C).
- They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
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 |
|---|---|---|
| MF59 adjuvanted H1N1 influenza monovalent vaccineAlso: Focetria™One/two single administration | Biological | H1N1sw monovalent vaccine |
| Thymosin alpha 1Also: Zadaxin1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0) | Drug | Thymosin alpha 1 3.2mg |
| Thymosin alpha 1Also: Zadaxin1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0) | Drug | Thymosin alpha 1 6.4 mg |
Primary outcome
The measures of immunogenicity, as determined by HI; MN and SRH
Time frame: Geometric mean HI titer (GMT) on Day 0, Day 21, Day 42, Day 84 and Day 168 for the primary course
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 29 Mar 2012.
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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.
Agostino Naso, MD principal investigator
Second Division of Nephrology and Dialysis - Padua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MF59 adjuvanted H1N1 influenza monovalent vaccine and Thymosin alpha 1 in people with END STAGE RENAL DISEASE, run by sigma-tau i.f.r. S.p.A. at 1 site in Italy.
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 5 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 29 Mar 2012. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The measures of immunogenicity, as determined by HI; MN and SRH (time frame: Geometric mean HI titer (GMT) on Day 0, Day 21, Day 42, Day 84 and Day 168 for the primary course). 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 29 Mar 2012.