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

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.

Study Overview

• Status: Completed
• Conditions: END STAGE RENAL DISEASE
• Intervention / Treatment: Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine; Drug: Thymosin alpha 1; Drug: Thymosin alpha 1

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: H1N1sw monovalent vaccine	Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine; One/two single administration; Other Names: 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 Names: Zadaxin; 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 Names: Zadaxin
Experimental: Thymosin alpha 1 6.4 mg	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 Names: Zadaxin; 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 Names: Zadaxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: sigma-tau i.f.r. S.p.A.
• Investigators: Principal Investigator: Agostino Naso, MD, Second Division of Nephrology and Dialysis - Padua Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): March 29, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: ESRD
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Thymalfasin
• Other Study ID Numbers: ST1472-DM-09-005