Study of Thymalfasin Thymosin Alpha 1 to Boost Immune Response in Adults 65 and Older Receiving COVID-19 Booster Shots

What this Trial Is About

Researchers are studying whether Thymalfasin Thymosin Alpha 1 Ta1, a naturally occurring peptide that stimulates the immune system, can improve the immune response to COVID-19 vaccine booster doses in adults aged 65 and older. This phase 1 trial aims to evaluate the safety and potential side effects of different doses of Ta1 given before vaccination. The study is sponsored by The Methodist Hospital Research Institute and focuses on enhancing vaccine responses in older adults. Participants are randomly assigned to one of three groups no Ta1 before vaccination, a single 4.8 mg dose of Ta1 on Day 0 before vaccination, or two 4.8 mg doses of Ta1 on Day 0 and Day 3 before vaccination. The vaccine used is a SARS-CoV-2 mRNA booster dose. Ta1 is given as injections with specific dosing schedules to assess its effect on immune response when combined with the COVID-19 vaccine. During the study, participants are monitored for safety and possible adverse events for up to 52 weeks. Researchers also measure the levels of neutralizing and non-neutralizing antibodies, neutralizing activity against SARS-CoV-2, and T cell responses over 24 weeks. Participants will undergo assessments including monitoring for side effects, immune response testing, and follow-up visits to evaluate the impact of Ta1 on vaccine effectiveness and safety.

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