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

Purpose

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.

Condition	Intervention	Phase
END STAGE RENAL DISEASE	Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine Drug: Thymosin alpha 1	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu Shot Kidney Failure

U.S. FDA Resources

Further study details as provided by sigma-tau i.f.r. S.p.A.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]


Enrollment:	120
Study Start Date:	November 2009
Study Completion Date:	July 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031966

Locations


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

Sponsors and Collaborators

sigma-tau i.f.r. S.p.A.

Investigators


Principal Investigator:	Agostino Naso, MD	Second Division of Nephrology and Dialysis - Padua Hospital

More Information


Responsible Party:	sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:	NCT01031966 History of Changes
Other Study ID Numbers:	ST1472-DM-09-005
Study First Received:	December 11, 2009
Last Updated:	March 28, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by sigma-tau i.f.r. S.p.A.:


ESRD

Additional relevant MeSH terms:


Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Vaccines	Thymalfasin Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Antineoplastic Agents

ClinicalTrials.gov processed this record on September 27, 2016