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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 100
Healthy Volunteers: t
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⁃ 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.

Locations
United States
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Eleftherios Mylonakis, MD, PhD
emylonakis@houstonmethodist.org
7134411576
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 75
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute

This content was sourced from clinicaltrials.gov