Actively Recruiting
Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
Led by The Methodist Hospital Research Institute · Updated on 2025-07-31
75
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 or greater
- Able and willing to provide informed consent or have consent provided by a legally authorized representative
- Scheduled for SARS-CoV-2 mRNA vaccination booster dose
- If male, agrees to use barrier contraception from Day 1 through 30 days after last study drug dose
You will not qualify if you...
- Hypoxemia with oxygen saturation ≤93% on room air or need for supplemental oxygen
- Acute liver failure or acute kidney failure as defined in criteria
- Heart failure classified as NYHA III or IV
- Advanced cancer treated with cytotoxic chemotherapy
- End stage renal disease requiring dialysis or chronic kidney disease with GFR <30 mL/min/1.73m2
- Known cirrhosis with Child-Pugh score B or C
- Moderate or severe immunocompromised state, including active treatment for tumors, hematologic malignancies, recent transplants, primary immunodeficiencies, advanced untreated HIV, or active high-dose immunosuppressive treatment
- Uncontrolled autoimmune or rheumatologic disease
- History of myocarditis, pericarditis, or myopericarditis
- History of anemia or bleeding disorders as specified
- Precautions or contraindications to COVID-19 vaccine as per CDC guidelines
- History of allergy or intolerance to Ta1
- SARS-CoV-2 or other infection during screening
- SARS-CoV-2 vaccination within previous 6 months
- Dermatologic conditions affecting injection site
- Any condition interfering with treatment or protocol compliance
- Receipt of investigational drug within previous 30 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eleftherios Mylonakis, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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