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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: sigma-tau i.f.r. S.p.A.
• Treatments: Thymalfasin; Vaccines

Criteria

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.