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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Thymalfasin (Thymosin Alpha 1; Ta1) to see if it can improve the immune response to COVID-19 booster vaccines in adults aged 65 and older. This phase 1 study aims to assess the safety and potential side effects of Ta1 when given before vaccination, as Ta1 is known to stimulate the immune system to fight infections. Participants are randomly assigned to one of three groups: no Ta1 before vaccination, a single dose of 4.8 mg Ta1 on Day 0 before vaccination, or two doses of 4.8 mg Ta1 on Day 0 and Day 3 before vaccination. The study evaluates different dosing schedules to explore Ta1's effect on vaccine response. During the study, participants will be monitored for safety and immune response over 52 weeks, including tracking treatment-emergent adverse events. Researchers will measure antibody levels, neutralizing activity against SARS-CoV-2, and T cell response up to 24 weeks after vaccination. The study includes regular health assessments and follow-up visits to evaluate the effects and tolerability of the treatment.
CONDITIONS
Brief 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 years or older
- Able and willing to provide informed consent or have consent given by a legally authorized representative
- Scheduled to receive a SARS-CoV-2 mRNA vaccine booster dose
- If male, agrees to use barrier contraception from Day 1 through 30 days after last dose of study drug
You will not qualify if you...
- Oxygen saturation less than or equal to 93% on room air or requiring supplemental oxygen
- Acute liver failure without pre-existing liver disease
- Acute kidney failure with recent significant creatinine increase or low urine output
- 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 very low kidney function
- Known cirrhosis with Child-Pugh score B or C
- Moderately or severely immunocompromised including active cancer treatment, hematologic malignancies, organ transplant recipients, recent CAR T-cell or hematopoietic cell transplant, primary immunodeficiency, advanced or untreated HIV infection, or receiving strong immunosuppressive therapies
- Uncontrolled autoimmune or rheumatologic disease
- Received 6 or more COVID-19 vaccine doses
- History of myocarditis, pericarditis, or myopericarditis
- History of anemia or bleeding disorders meeting specific criteria
- Precautions or contraindications to COVID-19 vaccines per CDC guidelines including severe allergic reactions
- Allergy or intolerance to Ta1
- Current infection with SARS-CoV-2 or other infections during screening
- COVID-19 vaccination within previous 6 months
- Dermatologic conditions affecting injection site assessment
- Any medical condition interfering with treatment or protocol compliance
- Received investigational drug within previous 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day for dosing followed by vaccination
Participants receive doses of Thymalfasin (Thymosin alpha 1) on Day 0 or Day 0 and Day 3, followed by a COVID-19 vaccine booster dose.
1 treatment visit (in-person)
Duration - Up to 24 weeks
Participants are monitored for safety, tolerability, and immune response for up to 24 weeks after vaccination.
Weekly visits for up to 4 weeks, then monthly visits up to Week 24
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eleftherios Mylonakis, MD, PhD
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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