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.
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.
Hypoxemia for any reason, defined as either oxygen saturation (SpO2) ≤ 93% on room air or a requirement for supplemental oxygen support.
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.
Parallel
Thymalfasin (Thymosin alpha 1, Ta1)
DrugTa1 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.
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
Levels of neutralizing and non-neutralizing antibodies
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
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
T cell response
T cell response. Data will be summarized descriptively for each treatment arm and no formal hypothesis testing is planne
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