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

The goal of this research is to learn more about ZADAXIN® (trade name; thymalfasingeneric; Ta1 for short) and determine if Ta1 has any benefit in increasing the immuneresponse to the COVID-19 vaccine. Ta1 has been shown to stimulate the immune system tofight infections.This research study will test the safety and possible harms of Ta1 when it is given topeople at different dose levels before COVID-19 vaccination.

Detailed Description

Not Provided

Recruiting
Vaccine Response
COVID-19 Vaccine
Immune Response to Covid 19 Vaccination

Drug: Thymalfasin (Thymosin alpha 1, Ta1)

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.

Eligibility Criteria

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 exclusion criteria should be assessed using historical records and lab
results available in the subjects' electronic medical records.

1. Hypoxemia for any reason, defined as either oxygen saturation (SpO2) ≤ 93% on room
air or a requirement for supplemental oxygen support.

2. Participants with one of the following:

- 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.

3. Advanced cancer being treated with cytotoxic chemotherapy.

4. Participants have end stage renal disease requiring hemodialysis or peritoneal
dialysis, or chronic kidney disease with GFR < 30 mL/min/1.73m2

5. Participants with a known history of cirrhosis and Child-Pugh score B or C.

6. Participants who are moderately or severely immunocompromised defined as:

- Are receiving active treatment for solid tumor and hematologic malignancies.

- Have hematologic malignancies (e.g., chronic lymphocytic lymphoma, non- Hodgkin
lymphoma, multiple myeloma, acute leukemia) and are known to have poor
responses to COVID-19 vaccines, regardless of the treatment status for the
hematologic malignancy.

- Received a solid-organ or islet transplant and are receiving immunosuppressive
therapy.

- Received chimeric antigen receptor T cell (CAR T-cell) therapy or a
hematopoietic cell transplant (HCT) and are within 2 years of transplantation
or are receiving immunosuppressive therapy.

- Have a moderate or severe primary immunodeficiency (e.g., severe combined
immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome, common variable
immunodeficiency disease).

- Have advanced or untreated HIV infection (defined as people with HIV and CD4 T
lymphocyte cell counts <200 cells/mm3, a history of an AIDS-defining illness
without immune reconstitution, or clinical manifestations of symptomatic HIV).

- Are receiving active treatment with high-dose corticosteroids (i.e., ≥20 mg
prednisone or equivalent per day for ≥2 weeks), alkylating agents,
antimetabolites, transplant-related immunosuppressive drugs, cancer
chemotherapeutic agents classified as severely immunosuppressive, or
immunosuppressive or immunomodulatory biologic agents (e.g., B cell-depleting
agents).

7. Participants with uncontrolled autoimmune or rheumatologic disease.

8. Participants have received 6 doses or more of the COVID-19 vaccine.

9. Participants with a history of myocarditis, pericarditis, or myopericarditis.

10. Participants with a history of anemia or bleeding disorders.

11. Participants who have precautions or contraindications to COVID-19 vaccine per the
CDC interim clinical considerations for use of COVID-19 vaccines, including the
following:

- History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose
or to a component of the COVID-19 vaccine

- History of a diagnosed non-severe allergy to a component of the COVID-19
vaccine

- History of a non-severe, immediate (onset less than 4 hours) allergic reaction
after administration of a previous dose of one COVID-19 vaccine type

- Moderate or severe acute illness, with or without fever

- History of multisystem inflammatory syndrome in adults

- History of myocarditis or pericarditis within 3 weeks after a dose of any
COVID-19 vaccine

12. History of allergy or intolerance to Ta1.

13. SARS-CoV-2 or other infection, during screening.

14. SARS-CoV-2 mRNA or other SARS-CoV-2 vaccination during the previous 6 months.

15. Participants who have dermatologic conditions that could affect local solicited
adverse event (AE) assessment (e.g., psoriasis patches affecting skin over the sites
of injection).

16. Any medical condition that, in the judgement of the Investigator, could interfere
with treatment or compliance with the protocol.

17. Has received an investigational drug within the previous 30 days.

Eligibility Gender
All
Eligibility Age
Minimum: 65 Years ~ Maximum: 100 Years
Countries
United States
Locations

Houston Methodist Hospital
Houston, Texas, United States

Investigator: Eleftherios Mylonakis, MD, PhD
Contact: 713-441-1576
emylonakis@houstonmethodist.org

Contacts

Eleftherios Mylonakis, MD, PhD
7134411576
emylonakis@houstonmethodist.org

Not Provided

The Methodist Hospital Research Institute
NCT Number
MeSH Terms
COVID-19
Thymalfasin