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

NCT01031966 | Completed Phase 2 DMC

• 1 other identifier: ST1472-DM-09-005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

END STAGE RENAL DISEASE

Keywords

ESRD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

H1N1sw monovalent vaccine

ACTIVE COMPARATOR

Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine

Thymosin alpha 1 3.2mg

EXPERIMENTAL

Drug: Thymosin alpha 1

Thymosin alpha 1 6.4 mg

EXPERIMENTAL

Drug: Thymosin alpha 1

Interventions

MF59 adjuvanted H1N1 influenza monovalent vaccine BIOLOGICAL

One/two single administration

Also known as: Focetria™

H1N1sw monovalent vaccine

Thymosin alpha 1 DRUG

1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)

Also known as: Zadaxin

Thymosin alpha 1 3.2mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Age \> 18 .
• Chronic dialysis for ESRD .
• Life expectancy of at least 6 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead

Study Sites (1)

Second Division of Nephrology and Dialysis - Padua Hospital

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

focetria; Thymalfasin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Agostino Naso, MD

  Second Division of Nephrology and Dialysis - Padua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

IT (1)