A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine
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ClinicalTrials.gov Identifier: NCT01031966 |
Recruitment Status :
Completed
First Posted : December 15, 2009
Last Update Posted : March 29, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
END STAGE RENAL DISEASE | Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine Drug: Thymosin alpha 1 | Phase 2 |
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 (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 |

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 |
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed written informed consent.
- Age > 18 .
- Chronic dialysis for ESRD .
- Life expectancy of at least 6 months.
Exclusion Criteria:
- They have any serious disease
- They are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
- They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
- Within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38°C).
- They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031966
Italy | |
Second Division of Nephrology and Dialysis - Padua Hospital | |
Padua, Italy, 35128 |
Principal Investigator: | Agostino Naso, MD | Second Division of Nephrology and Dialysis - Padua Hospital |
Responsible Party: | sigma-tau i.f.r. S.p.A. |
ClinicalTrials.gov Identifier: | NCT01031966 |
Other Study ID Numbers: |
ST1472-DM-09-005 |
First Posted: | December 15, 2009 Key Record Dates |
Last Update Posted: | March 29, 2012 |
Last Verified: | March 2012 |
ESRD |
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
Thymalfasin Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |