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RecruitingVaccine ResponseCOVID-19 VaccineImmune Response to Covid 19 Vaccination

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

Eligible age

65–100 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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.

Sponsor: The Methodist Hospital Research Institute

You may qualify if…

  • ✓ Subjects who meet all of the following criteria will be eligible to participate in the study:
  • ✓ 1. Age 65 or greater.
  • ✓ 2. Able and willing to provide informed consent or have consent provided by a legally authorized representative (LAR).
  • ✓ 3. Scheduled for SARS-CoV-2 mRNA vaccination booster dose.
  • ✓ 4. If a male subject, the subject must agree to use barrier contraception (ie, condoms) from Day 1 through 30 days following the last dose of study drug.

You may not qualify if…

  • ✕ Subjects who meet any of the following criteria will be excluded from participation in the study.
  • ✕ Laboratory related exclusion criteria should be assessed using historical records and lab results available in the subjects' electronic medical records.
  • ✕ 1. Hypoxemia for any reason, defined as either oxygen saturation (SpO2) ≤ 93% on room air or a requirement for supplemental oxygen support.
  • ✕ 2. 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.
  • ✕ Acute kidney failure defined as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days OR urine output of \<0.5 mL/kg/hour for \>6 hours
  • ✕ Heart failure with NYHA functional classification III or IV.
  • ✕ 3. Advanced cancer being treated with cytotoxic chemotherapy.

Where it's recruiting

Texas

Houston

Source: ClinicalTrials.gov · NCT06821100 · last updated 2025-07-31