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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

65 Years - 100 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Dec 2, 2024

Status verified

Jul 2025

Primary completion

Dec 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

75 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control
  No Ta1 prior to vaccination
• Experimental: Treatment arm A
  A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0, followed by vaccination
• Experimental: Treatment arm B
  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

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 52 weeks ]

Central Contacts

• Eleftherios Mylonakis, MD, PhD
  7134411576
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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