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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
Second Division of Nephrology and Dialysis - Padua Hospital
Padua, Italy, 35128

Sponsors and Collaborators

sigma-tau i.f.r. S.p.A.

Investigators

Principal Investigator:	Agostino Naso, MD	Second Division of Nephrology and Dialysis - Padua Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:	NCT01031966 History of Changes
Other Study ID Numbers:	ST1472-DM-09-005
First Posted:	December 15, 2009
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:

Kidney Diseases; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Vaccines	Thymalfasin; Immunologic Factors; Physiological Effects of Drugs; Adjuvants, Immunologic; Antineoplastic Agents