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

What Was Tested

This registered phase 2 trial tested Thymosin Alpha-1.

It had three arms (groups): H1N1sw monovalent vaccine (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

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.

Diminished antibody responses have also been reported in patients with end-stage renal disease.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed written informed consent. Age \> 18 . Chronic dialysis for ESRD . Life expectancy of at least 6 months.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Thymosin Alpha-1 study: the participants and staff both knew the treatment.

It started in 2009-11 with completion listed for 2010-05.

It ran at 1 site in Italy.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): 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).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.