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

NCT06821100 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRO00037612
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Response; COVID-19 Vaccine; Immune Response to Covid 19 Vaccination

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  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

  52 weeks

Secondary Outcomes (3)

• Levels of neutralizing and non-neutralizing antibodies

  24 weeks

• Neutralizing activity to SARS-CoV-2

  24 weeks

• T cell response

  24 weeks

Study Arms (3)

Control

NO INTERVENTION

No Ta1 prior to vaccination

Treatment arm A

EXPERIMENTAL

A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0, followed by vaccination

Drug: Thymalfasin (Thymosin alpha 1, Ta1)

Treatment arm B

EXPERIMENTAL

A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0 and Day 3, followed by vaccination

Drug: Thymalfasin (Thymosin alpha 1, Ta1)

Interventions

Thymalfasin (Thymosin alpha 1, Ta1) DRUG

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.

Treatment arm A; Treatment arm B

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects who meet all of the following criteria will be eligible to participate in the study:
• Age 65 or greater.
• Able and willing to provide informed consent or have consent provided by a legally authorized representative (LAR).
• Scheduled for SARS-CoV-2 mRNA vaccination booster dose.
• 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.
• Hypoxemia for any reason, defined as either oxygen saturation (SpO2) ≤ 93% on room air or a requirement for supplemental oxygen support.
• 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.
• Advanced cancer being treated with cytotoxic chemotherapy.
• Participants have end stage renal disease requiring hemodialysis or peritoneal dialysis, or chronic kidney disease with GFR \< 30 mL/min/1.73m2
• Participants with a known history of cirrhosis and Child-Pugh score B or C.
• Participants who are moderately or severely immunocompromised defined as:
• Are receiving active treatment for solid tumor and hematologic malignancies.
• Have hematologic malignancies (e.g., chronic lymphocytic lymphoma, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) and are known to have poor responses to COVID-19 vaccines, regardless of the treatment status for the hematologic malignancy.
• Received a solid-organ or islet transplant and are receiving immunosuppressive therapy.
• Received chimeric antigen receptor T cell (CAR T-cell) therapy or a hematopoietic cell transplant (HCT) and are within 2 years of transplantation or are receiving immunosuppressive therapy.
• Have a moderate or severe primary immunodeficiency (e.g., severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome, common variable immunodeficiency disease).

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Thymalfasin; Trace amine-associated receptor 1

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Central Study Contacts

Eleftherios Mylonakis, MD, PhD

CONTACT

7134411576; emylonakis@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized open label Phase 1 study to evaluate the safety and tolerability of different treatment regimens of Ta1 before vaccination with a SARS-CoV-2 mRNA vaccine. Study participants will be randomized in a 1:1:1 ratio to one of the following treatment groups: * No Ta1 prior to vaccination (Control) * A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0, followed by vaccination (Treatment arm A) * A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0 and Day 3, followed by vaccination (Treatment arm B) * All participants will receive the same mRNA SARS-CoV-2 mRNA vaccine (Moderna or Pfizer) for consistency.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 11, 2025
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)