Vaccine Response, COVID-19 Vaccine, Immune Response to Covid 19 Vaccination
Conditions
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.
Interventions
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.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized open label Phase 1 study to evaluate the safety and tolerability of different treatment regimens of Ta1 before vaccination with a SARS-CoV-2 mRNA vaccine. Study participants will be randomized in a 1:1:1 ratio to one of the following treatment groups: * No Ta1 prior to vaccination (Control) * 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 A) * 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 (Treatment arm B) * All participants will receive the same mRNA SARS-CoV-2 mRNA vaccine (Moderna or Pfizer) for consistency.
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects who meet all of the following criteria will be eligible to participate in the study: 1. Age 65 or greater. 2. Able and willing to provide informed consent or have consent provided by a legally authorized representative (LAR). 3. Scheduled for SARS-CoV-2 mRNA vaccination booster dose. 4. 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.
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from participation in the study. Laboratory related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| T cell response | 24 weeks | T cell response. Data will be summarized descriptively for each treatment arm and no formal hypothesis testing is planne |
Countries
United States
Contacts
Primary ContactEleftherios Mylonakis, MD, PhD
Outcome results
None listed