BIOLOGICAL
MF59 adjuvanted H1N1 influenza monovalent vaccine
One/two single administration
A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine
Status
Completed
Phase
Phase 2
Enrollment
120
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
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)
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)
Timeline
From registration to results.
First posted
Dec 15, 2009
Study start
Nov 2009
Primary completion
May 2010
Study completion
Jul 2010
Results posted
Not reported
Registry updated
Mar 29, 2012
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Italy. Showing up to 24 locations stored in the fast local snapshot.
Second Division of Nephrology and Dialysis - Padua Hospital
Padua, Italy
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Thymosin Alpha-1.
NCT IDStudyPhase / statusEnrollmentUpdated
Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
The Methodist Hospital Research Institute · Vaccine Response · COVID-19 Vaccine
Phase 1
Recruiting
75
2026-07
Thymosin-α1 for Recurrent Implantation Failure
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Phase 2 / Phase 3
Recruiting
136
2026-06
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
Beijing Friendship Hospital · Colorectal Neoplasms
Not applicable
Completed
47
2026-06
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Sun Yat-sen University · Melanoma · Immune-related Adverse Event
Phase 2
Recruiting
55
2026-06
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
Fudan University · Esophageal Squamous Cell Carcinoma
Not applicable
Active, not recruiting
50
2026-04
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
William B. Ershler, MD · COVID-19
Phase 2
Completed
189
2026-04
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
The First Affiliated Hospital with Nanjing Medical University · Gastric Cancer
Phase 2
Recruiting
48
2026-03
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
Zekuan Xu · Gastric Cancer · Esophagogastric Junction Adenocarcinoma
Phase 2
Recruiting
30
2026-03
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Put the record in context.
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