A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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END STAGE RENAL DISEASE

Intervention / Treatment
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* Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine
* Drug: Thymosin alpha 1
* Drug: Thymosin alpha 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent. Age > 18 . Chronic dialysis for ESRD . Life expectancy of at least 6 months. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: H1N1sw monovalent vaccine<br> | Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine<br>* One/two single administration<br>* Other names: Focetria™;|
| Experimental: Thymosin alpha 1 3.2mg<br> | Drug: Thymosin alpha 1<br>* 1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)<br>* Other names: Zadaxin;|
| Experimental: Thymosin alpha 1 6.4 mg<br> | Drug: Thymosin alpha 1<br>* 1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)<br>* Other names: Zadaxin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measures of immunogenicity, as determined by HI; MN and SRH |  | Geometric mean HI titer (GMT) on Day 0, Day 21, Day 42, Day 84 and Day 168 for the primary course | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD