Thymalfasin to Boost COVID-19 Vaccine Response in Seniors

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

Recruiting Phase 1 Interventional Study
Vaccine Response COVID-19 Vaccine Immune Response to Covid 19 Vaccination
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
65 – 100
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
Who this trial is looking for

This trial is looking for older adults who are getting a COVID-19 booster shot. Participants will take a medication called Thymalfasin before their vaccination to see if it enhances their immune response.

Are You a Good Fit for This Trial?
Rules you out Acute liver failureAcute kidney failureHeart failureEnd stage renal diseaseSevere immunocompromised stateUncontrolled autoimmune diseaseMyocarditis or pericarditisAnemia

You may be able to join if

  • I am 65 years old or older.
  • I can give informed consent or have someone to help me.
  • I am scheduled for a COVID-19 mRNA vaccine booster dose.
  • If I am male, I agree to use barrier contraception.

You may not be able to join if

  • I have low blood oxygen levels.
  • I have acute liver or kidney failure.
  • I have severe heart failure.
  • I am being treated for advanced cancer with chemotherapy.
  • I am on hemodialysis or have severe chronic kidney disease.
  • I have a history of severe allergies to COVID-19 vaccines.
  • I had a severe allergic reaction to Thymalfasin.
  • I have had an infection in the last few days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria 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…
Contacts

Eleftherios Mylonakis, MD, PhD

7134411576

emylonakis@houstonmethodist.org

CONTACT