Thymosin-alpha 1 (Zadaxin) enhances the immunogenicity of an adjuvated pandemic H1N1v influenza vaccine (Focetria) in hemodialyzed patients: a pilot study.

Carraro G, Naso A, Montomoli E, Gasparini R, Camerini R, Panatto D, Tineo MC, De Giorgi L, Piccirella S, Khadang B, Ceracchi M, De Rosa A

Vaccine14 Dec 2011Cited by 20 (Europe PMC)

PMID22178096DOI10.1016/j.vaccine.2011.12.014PepBankPUB-22178096

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialSafety outcome
In hemodialyzed patients, no adverse event was related to thymosin α1 or to the Focetria vaccine.
In plain wordsIn dialysis patients, no side effect was linked to thymosin α1 or to the flu vaccine.
Peptide
Thymosin alpha-1
Outcome
No significant changeAdverse events related to thymosin α1
Study
n = 99
Outcome group
Adverse events · Immune and inflammation
Studied dose
3.2 mg and 6.4 mgAs given in this study (human).
Source sentences
Summary
No AE was found to be related to Thymosin alpha 1 nor to the Focetria vaccine.
2 context sentences(design, population, supporting numbers)
Summary · context
This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1.
Summary · context
Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively).
Report a problemFND-2217809607
02HumanNon-randomized trialEfficacy outcome
In hemodialyzed patients given an adjuvanted H1N1v vaccine, adding thymosin α1 (3.2 mg and 6.4 mg) gave a better HI geometric mean titer at day 21 than vaccine only (ITT population).
In plain wordsIn dialysis patients, adding thymosin α1 to a flu vaccine gave a better antibody titer at day 21 than vaccine alone.
Peptide
Thymosin alpha-1
Outcome
IncreaseHemagglutination inhibition geometric mean titer (GMT) at day 21
Study
n = 94
Comparator
Vaccine only (Focetria)
Outcome group
Immune response · Immune and inflammation
Studied dose
3.2 mg and 6.4 mgAs given in this study (human).
Source sentences
Summary
With regard to the Geometric Mean Titer (GMT) and the Geometric Mean Ratio (GMR) of HI on Day 21 in the ITT population, both "Vaccine+Thymosin alpha 1" groups presented better results than the "Vaccine only" group.
2 context sentences(design, population, supporting numbers)
Summary · context
This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1.
Summary · context
Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively).
Report a problemFND-2217809601
03HumanNon-randomized trialEfficacy outcome
In hemodialyzed patients given an adjuvanted H1N1v vaccine, adding thymosin α1 (3.2 mg and 6.4 mg) gave a better HI geometric mean ratio at day 21 than vaccine only (ITT population).
In plain wordsIn dialysis patients, adding thymosin α1 to a flu vaccine gave a better antibody ratio at day 21 than vaccine alone.
Peptide
Thymosin alpha-1
Outcome
IncreaseHemagglutination inhibition geometric mean ratio (GMR) at day 21
Study
n = 94
Comparator
Vaccine only (Focetria)
Outcome group
Immune response · Immune and inflammation
Studied dose
3.2 mg and 6.4 mgAs given in this study (human).
Source sentences
Summary
With regard to the Geometric Mean Titer (GMT) and the Geometric Mean Ratio (GMR) of HI on Day 21 in the ITT population, both "Vaccine+Thymosin alpha 1" groups presented better results than the "Vaccine only" group.
2 context sentences(design, population, supporting numbers)
Summary · context
This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1.
Summary · context
Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively).
Report a problemFND-2217809602
04HumanNon-randomized trialEfficacy outcome
In hemodialyzed patients given an adjuvanted H1N1v vaccine, a large proportion of patients in the two vaccine with thymosin α1 groups achieved seroconversion by day 21 (ITT population).
In plain wordsIn dialysis patients, many of those given thymosin α1 with a flu vaccine had a protective antibody response by day 21.
Peptide
Thymosin alpha-1
Outcome
IncreaseSeroconversion by day 21
Study
n = 94
Outcome group
Immune response · Immune and inflammation
Studied dose
3.2 mg and 6.4 mgAs given in this study (human).
Source sentences
Summary
A large proportion of ITT patients in the two Vaccine+Thymosin alpha 1 groups achieved seroconversion by Day 21.
2 context sentences(design, population, supporting numbers)
Summary · context
This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1.
Summary · context
Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively).
Report a problemFND-2217809603
05HumanNon-randomized trialEfficacy outcome
In the per-protocol population of hemodialyzed patients, results on HI response were similar to those in the ITT population, with better results for vaccine with thymosin α1.
In plain wordsIn dialysis patients who followed the study plan, thymosin α1 with a flu vaccine also gave better antibody results than vaccine alone.
Peptide
Thymosin alpha-1
Outcome
IncreaseHI response in the per-protocol population
Study
n = 82
Comparator
Vaccine only (Focetria)
Outcome group
Immune response · Immune and inflammation
Studied dose
3.2 mg and 6.4 mgAs given in this study (human).
Source sentences
Summary
With regard to the Geometric Mean Titer (GMT) and the Geometric Mean Ratio (GMR) of HI on Day 21 in the ITT population, both "Vaccine+Thymosin alpha 1" groups presented better results than the "Vaccine only" group.
3 context sentences(design, population, supporting numbers)
Summary · context
Similar results were obtained in the PP population.
Summary · context
This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1.
Summary · context
Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively).
Report a problemFND-2217809605
06HumanNon-randomized trialEfficacy outcome
In hemodialyzed patients given an adjuvanted H1N1v vaccine, the day 42 decrease in HI geometric mean titer was greater with added thymosin α1 than with vaccine only.
In plain wordsIn dialysis patients, antibody titers fell more by day 42 with thymosin α1 added to a flu vaccine than with vaccine alone.
Peptide
Thymosin alpha-1
Outcome
DecreaseDecrease in HI geometric mean titer at day 42
Study
n: not reported in source
Comparator
Vaccine only (Focetria)
Outcome group
Immune response · Immune and inflammation
Studied dose
3.2 mg and 6.4 mgAs given in this study (human).
Source sentences
Summary
On Day 42, the decrease in the GMT of HI was greater in the Vaccine+Thymosin alpha 1 groups than in the vaccine only group.
2 context sentences(design, population, supporting numbers)
Summary · context
This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1.
Summary · context
Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively).
Report a problemFND-2217809604
07HumanNon-randomized trialEfficacy outcome
In hemodialyzed patients, the CHMP criteria were fully met in the groups treated with vaccine and thymosin α1.
In plain wordsIn dialysis patients, groups given thymosin α1 with a flu vaccine met all the regulatory immune response criteria.
Peptide
Thymosin alpha-1
Outcome
Not applicableFulfilment of CHMP criteria for vaccine licensing
Study
n: not reported in source
Outcome group
Immune response · Immune and inflammation
Studied dose
3.2 mg and 6.4 mgAs given in this study (human).
Source sentences
Summary
The CHMP criteria were fully met in the groups treated with Vaccine+Thymosin alpha 1.
2 context sentences(design, population, supporting numbers)
Summary · context
This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1.
Summary · context
Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively).
Report a problemFND-2217809606

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
10 Oct 2026, 08:55 UTC
Study results updated
Version 2
9 Oct 2026, 03:03 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:02 UTC
First added · source update from Europe PMC

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