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

END STAGE RENAL DISEASE Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031966
• Other study ID #: ST1472-DM-09-005
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2009
• Last updated: March 28, 2012
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2012
• Source: sigma-tau i.f.r. S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• END STAGE RENAL DISEASE
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Biological:
• MF59 adjuvanted H1N1 influenza monovalent vaccine
One/two single administration

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)
• 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)

Locations

Country	Name	City	State
Italy	Second Division of Nephrology and Dialysis - Padua Hospital	Padua

Sponsors (1)

Lead Sponsor	Collaborator
sigma-tau i.f.r. S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes