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Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
Plain-language guide to NCT06821100: phase 1 randomized trial of Thymosin Alpha-1, 75 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06821100
- Phase
- phase 1
- Status
- recruiting participants
- Start
- 2024-12-02
- Completion (planned or actual)
- 2026-12-01
- Participants
- 75 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Vaccine Response; COVID-19 Vaccine; Immune Response to Covid 19 Vaccination
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Thymosin Alpha-1.
It had three arms (groups): Control (no intervention), Treatment arm A (experimental) and Treatment arm B (experimental).
No Ta1 prior to vaccination.
The registry classes the interventions as drug.
Who Took Part
The registry lists 75 planned participants were the target.
It was open to people of any sex aged from 65 years up to 100 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 65 or greater. Able and willing to provide informed consent or have consent provided by a legally authorized representative (LAR).
The full record lists 4 inclusion and 33 exclusion criteria; among the exclusions: participants with one of the following:; acute liver failure defined as inr ≥ 1.5 and altered mental status in a patient without cirrhosis or pre-existing liver disease; heart failure with nyha functional classification iii or iv.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Thymosin Alpha-1 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Thymosin Alpha-1 study: the participants and staff both knew the treatment.
It started in 2024-12-02 with completion listed for 2026-12-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 52 weeks).
It also tracked 3 secondary outcomes, for example Levels of neutralizing and non-neutralizing antibodies, Neutralizing activity to SARS-CoV-2 and T cell response.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Thymosin Alpha-1 in 75 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Thymosin Alpha-1 compound page, all human trials.
Our Notes on the Compound
Thymosin Alpha-1: An immune-modulating thymic peptide that recalibrates T-cell function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.