BridgeMD
New treatment option for Vaccine Response
Official title Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
ClinicalTrials.gov ID: NCT06821100
What this study is testing
What is Thymalfasin (Thymosin alpha 1, Ta1)?
Thymalfasin (Thymosin alpha 1, Ta1) is an investigational medicine, being studied as a potential treatment for vaccine response.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 100. Healthy volunteers may be eligible.
You may be able to join if
- people who meet all of the following criteria will be eligible to participate in the study:
- 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.
You likely can't join if
- people who meet any of the following criteria will be excluded from participation in the study. Laboratory related exclusion criteria should be...
- Hypoxemia for any reason, defined as either oxygen saturation (SpO2) ≤ 93% on room air or a requirement for supplemental oxygen support.
- 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 \ 6 hours
- Heart failure with NYHA functional classification III or IV.
See the full eligibility criteria
- people who meet all of the following criteria will be eligible to participate in the study:
- 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.
- people 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 people'...
- Hypoxemia for any reason, defined as either oxygen saturation (SpO2) ≤ 93% on room air or a requirement for supplemental oxygen support.
- 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 \ 6 hours
- Heart failure with NYHA functional classification III or IV.
- Advanced cancer being treated with cytotoxic chemotherapy.
- Participants have end stage renal disease requiring hemodialysis or peritoneal dialysis, or chronic kidney disease with GFR \< 30 mL/min/1.73m2
- Participants with a known history of cirrhosis and Child-Pugh score B or C.
- 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...
- 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...
- 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...
- Participants with uncontrolled autoimmune or rheumatologic disease.
- Participants have received 6 doses or more of the COVID-19 vaccine. (Removed in Amendment 3)
- Participants with a history of myocarditis, pericarditis, or myopericarditis.
- Participants with a history of anemia or bleeding disorders. For anemia, the exclusion criterion will be met if any of the following are true: i. Active anemia, defined as Hb\ =3 months in the past year AND no evidence...
- 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 COVID19 vaccine
- History of allergy or intolerance to Ta1.
- SARS-CoV-2 or other infection, during screening.
- SARS-CoV-2 mRNA or other SARS-CoV-2 vaccination during the previous 6 months.
- 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).
- Any medical condition that, in the judgement of the Investigator, could interfere with treatment or compliance with the protocol.
- Has received an investigational drug within the previous 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.