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

Phase 1

Recruiting

• Conditions: Vaccine Response; COVID-19 Vaccine; Immune Response to Covid 19 Vaccination
• Interventions: Drug: Thymalfasin (Thymosin alpha 1, Ta1)

• Registration Number: NCT06821100
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-02
• Study First Submitted: 2025-01-15
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm A	Thymalfasin (Thymosin alpha 1, Ta1)	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 B	Thymalfasin (Thymosin alpha 1, Ta1)	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 Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	52 weeks	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

Secondary Outcome Measures

Name	Time	Method
T cell response	24 weeks	T cell response. Data will be summarized descriptively for each treatment arm and no formal hypothesis testing is planne
Levels of neutralizing and non-neutralizing antibodies	24 weeks	Levels of neutralizing and non-neutralizing antibodies. Data will be summarized descriptively for each treatment arm and no formal hypothesis testing is planned
Neutralizing activity to SARS-CoV-2	24 weeks	Neutralizing activity to SARS-CoV-2, measured using a using a pseudovirus neutralization assay. Data will be summarized descriptively for each treatment arm and no formal hypothesis testing is planned

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States