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

Phase 2

Completed

• Conditions: END STAGE RENAL DISEASE
• Interventions: Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine; Drug: Thymosin alpha 1

• Registration Number: NCT01031966
• Lead Sponsor: sigma-tau i.f.r. S.p.A.

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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H1N1sw monovalent vaccine	MF59 adjuvanted H1N1 influenza monovalent vaccine	-
Thymosin alpha 1 6.4 mg	Thymosin alpha 1	-
Thymosin alpha 1 3.2mg	Thymosin alpha 1	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Second Division of Nephrology and Dialysis - Padua Hospital; 🇮🇹 Padua, Italy