Recruiting
PHASE1
INTERVENTIONAL
NCT06821100
Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Thymalfasin (Thymosin alpha 1, Ta1)
Type:
DRUG
Description:
Ta1 is a naturally occurring peptide that has been evaluated for its immunomodulatory activities and related therapeutic potential in several conditions and diseases. Ta1 has been shown to provide increased response to vaccines.
Primary Outcomes
Measure:
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
TimeFrame:
52 weeks
Description:
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
Trial Information
NCT ID
NCT06821100
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
The Methodist Hospital Research Institute
Last Updated
December 15, 2025