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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01031966
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
sigma-tau i.f.r. S.p.A.

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
END STAGE RENAL DISEASE Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine Drug: Thymosin alpha 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: H1N1sw monovalent vaccine Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine
One/two single administration
Other Name: Focetria™
Experimental: Thymosin alpha 1 3.2mg Drug: Thymosin alpha 1
1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)
Other Name: Zadaxin
Experimental: Thymosin alpha 1 6.4 mg Drug: Thymosin alpha 1
1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)
Other Name: Zadaxin


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent.
  2. Age > 18 .
  3. Chronic dialysis for ESRD .
  4. Life expectancy of at least 6 months.

Exclusion Criteria:

  1. They have any serious disease
  2. They are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
  3. They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
  4. Within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38°C).
  5. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031966


Locations
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Italy
Second Division of Nephrology and Dialysis - Padua Hospital
Padua, Italy, 35128
Sponsors and Collaborators
sigma-tau i.f.r. S.p.A.
Investigators
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Principal Investigator: Agostino Naso, MD Second Division of Nephrology and Dialysis - Padua Hospital
More Information
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Responsible Party: sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier: NCT01031966    
Other Study ID Numbers: ST1472-DM-09-005
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by sigma-tau i.f.r. S.p.A.:
ESRD
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
 Thymalfasin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs