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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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END STAGE RENAL DISEASE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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H1N1sw monovalent vaccine

Group Type ACTIVE_COMPARATOR

MF59 adjuvanted H1N1 influenza monovalent vaccine

Intervention Type BIOLOGICAL

One/two single administration

Thymosin alpha 1 3.2mg

Group Type EXPERIMENTAL

Thymosin alpha 1

Intervention Type DRUG

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 6.4 mg

Group Type EXPERIMENTAL

Thymosin alpha 1

Intervention Type DRUG

1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)

Interventions

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MF59 adjuvanted H1N1 influenza monovalent vaccine

One/two single administration

Intervention Type BIOLOGICAL

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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Focetria™ Zadaxin Zadaxin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No