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NCT06821100 · ClinicalTrials.gov registry record · Phase 1

Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine

A Phase 1 study of COVID-19 Vaccine and Vaccine Response, sponsored by The Methodist Hospital Research Institute.

Recruiting
Registry status
Phase 1
Development phase
75
Enrollment target
1
Study location

NCT06821100: Recruiting Phase 1 study of COVID-19 Vaccine and Vaccine Response, sponsored by The Methodist Hospital Research Institute.

NCT06821100 is a Phase 1 study of COVID-19 Vaccine and Vaccine Response that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 75 participants, below the 5,881-participant average among 6 other COVID-19 Vaccine trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06821100, a Phase 1 study of COVID-19 Vaccine and Vaccine Response, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.

RECRUITING
Registry status
Phase 1
Development phase
75 participants
Enrollment target
1
Study location

Study Summary

The goal of this research is to learn more about ZADAXIN® (trade name; thymalfasin generic; Ta1 for short) and determine if Ta1 has any benefit in increasing the immune response to the COVID-19 vaccine. Ta1 has been shown to stimulate the immune system to fight infections. This research study will test the safety and possible harms of Ta1 when it is given to people at different dose levels before COVID-19 vaccination.

Primary Outcome

The primary objective is to evaluate the safety and tolerability of different treatment regimens of Ta1 before vaccination with a SARS-CoV-2 mRNA vaccine. This will be measured by: \- The incidence and severity of adverse events (AEs) following treatment

Interventions

  • DRUG Thymalfasin (Thymosin alpha 1, Ta1)

Study Locations (1)

Texas

  • Houston Methodist Hospital - Houston

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2024-12-02
Est. Completion 2026-12-01
Phase Phase 1

What NCT06821100 shows while recruiting

NCT06821100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 5,881-participant average among 6 other COVID-19 Vaccine trials with a reported enrollment target (99% lower).

The record links to 3 conditions, with COVID-19 Vaccine appearing as the primary indexed condition, and to 1 intervention - of which Thymalfasin (Thymosin alpha 1, Ta1) is the first listed.

NCT06821100 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06821100 about?

NCT06821100 is a clinical study titled "Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine". The goal of this research is to learn more about ZADAXIN® (trade name; thymalfasin generic; Ta1 for short) and determine if Ta1 has any benefit in increasing the immune response to the COVID-19 vaccine. Ta1 has been shown to stimulate the immune system to fight infections. This research study will ...

What is the current status of trial NCT06821100?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2024-12-02. Estimated completion is 2026-12-01.

What conditions does trial NCT06821100 study?

This clinical trial studies the following conditions: COVID-19 Vaccine, Vaccine Response, Immune Response to Covid 19 Vaccination.

What interventions are being tested in trial NCT06821100?

The interventions under investigation include: Thymalfasin (Thymosin alpha 1, Ta1) (DRUG).

Who is sponsoring clinical trial NCT06821100?

This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06821100 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06821100, the US trial registry maintained by the National Library of Medicine. NCT06821100 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.