Thymalfasin for Coronavirus Vaccine Response

Overseen By Eleftherios Mylonakis, MD, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Methodist Hospital Research Institute

Must not be taking: High-dose corticosteroids, Immunosuppressants

Disqualifiers: Hypoxemia, Advanced cancer, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

75 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on certain treatments like high-dose corticosteroids or other immunosuppressive drugs, you may be excluded from participating.

What data supports the effectiveness of the drug Thymalfasin for enhancing the immune response?

Thymalfasin has been shown to boost the immune system in various conditions, such as chronic hepatitis B and C, AIDS, and certain cancers, by improving T-cell function and immune response. This suggests it might help enhance the body's defense against infections, which could be beneficial for improving vaccine responses. ^{1 2 3 4 5}

How is the drug Thymalfasin different from other COVID-19 treatments?

Thymalfasin is unique because it boosts the immune system by increasing T-cell numbers and supporting their development, which helps the body fight off viruses. Unlike other treatments that may directly target the virus, Thymalfasin enhances the body's natural defense mechanisms. ^{1 2 3 6 7}

Eligibility Criteria

This trial is for adults aged 65 or older who are scheduled to receive a COVID-19 vaccine booster and can consent to the study. They must agree to use barrier contraception post-treatment. People with severe immune compromise, certain medical conditions like advanced cancer, kidney failure, liver disease, heart failure, or those recently treated with investigational drugs cannot participate.

Inclusion Criteria

I am 65 years old or older.

Subjects must be able and willing to provide informed consent or have consent provided by a legally authorized representative (LAR)

I am scheduled to receive a COVID-19 mRNA booster shot.

Exclusion Criteria

My immune system is significantly weakened.

I have a history of anemia or bleeding disorders.

My kidney function has recently worsened significantly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4.8 mg dose of Ta1 on Day 0 and Day 3 (Treatment arm B) or only on Day 0 (Treatment arm A), followed by COVID-19 vaccination

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the incidence of treatment-emergent adverse events

52 weeks

Treatment Details

Interventions

• Thymalfasin (Thymosin Alpha 1; Ta1)

Trial Overview The study tests Thymalfasin (Ta1), which may boost the immune response to COVID-19 vaccines in older adults. Participants will receive different doses of Ta1 before their vaccine booster to assess its safety and effectiveness at enhancing vaccine-induced immunity.

Participant Groups

Group I: Treatment arm B Experimental Treatment 1 Intervention

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

Group II: Treatment arm A Experimental Treatment 1 Intervention

A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0, followed by vaccination

Group III: Control Active Control 1 Intervention

No Ta1 prior to vaccination

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Findings from Research

Thymalfasin (thymosin-alpha 1) is an immunomodulating agent that enhances the Th1 immune response and has shown potential in treating various diseases, including chronic hepatitis B and C, AIDS, and cancer, by improving immune system function.

In experimental models, thymalfasin has demonstrated efficacy in reconstituting immune function and exerting antitumor effects, particularly in cases of infectious diseases and cancers like melanoma and colorectal carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thymalfasin: an immune system enhancer for the treatment of liver disease. Sjogren, MH.[2018]

Thymalfasin (thymosin-alpha 1) is an immunomodulating agent that enhances the Th1 immune response and has shown potential in treating various diseases, including chronic hepatitis B and C, AIDS, and certain cancers.

It works by improving immune system parameters, promoting T-cell differentiation and maturation, and has demonstrated efficacy in experimental models of immune dysfunction, particularly in infectious diseases and cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thymalfasin: an immune system enhancer for the treatment of liver disease. Sjogren, MH.[2018]

Thymalfasin (thymosin-alpha1) enhances specific T lymphocyte functions, particularly boosting T helper 1 cell responses that are crucial for fighting viral infections.

It shows promising potential as a standalone treatment for chronic hepatitis B and in combination with interferon-alpha for both chronic hepatitis B and C, warranting further large-scale clinical trials to optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thymalfasin: clinical pharmacology and antiviral applications. Gramenzi, A., Cursaro, C., Andreone, P., et al.[2018]

Thymosin alpha 1 treatment in COVID-19 patients was associated with a significant reduction in 28-day mortality, with a hazard ratio of 0.45, indicating it may improve survival outcomes compared to standard care.

Patients receiving thymosin alpha 1 showed a greater decrease in C-reactive protein levels, a marker of inflammation, suggesting that it may help reduce inflammation in COVID-19, although it did not significantly affect ventilator-free days or lymphocyte counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thymosin alpha 1 for the adjuvant treatment of coronavirus disease 2019: a retrospective cohort study]. Wang, T., Lin, Q., Xie, Y., et al.[2022]

In a phase II trial involving 25 patients with unresectable hepatocellular carcinoma (HCC), the combination of transarterial chemoembolization (TACE) and thymalfasin showed a higher rate of patients becoming eligible for transplant (28.6%) compared to TACE alone (0%).

Patients receiving TACE plus thymalfasin had a median overall survival of 110.3 weeks, compared to 57.0 weeks for those receiving TACE alone, and experienced fewer bacterial infections, suggesting a potential benefit of thymalfasin in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of thymalfasin plus transarterial chemoembolization for unresectable hepatocellular carcinoma. Gish, RG., Gordon, SC., Nelson, D., et al.[2023]

In a phase III clinical study involving 105 moderate-to-severe COVID-19 patients, Thymosin α1 (Tα1) significantly reduced the death rate to 11.1% compared to 38.5% in the placebo group, indicating its potential efficacy in improving survival rates.

Tα1 also contributed to shorter hospital stays and reduced oxygen support needs, suggesting it positively impacts recovery time and overall patient outcomes when used alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-blind Multicenter Two-arm Randomized Placebo-controlled Phase-III Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α1 as an Add-on Treatment to Existing Standard of Care Treatment in Moderate-to-severe COVID-19 Patients. Shetty, A., Chandrakant, NS., Darnule, RA., et al.[2022]

In a study of 49 hospitalized COVID-19 patients with low-flow and high-flow oxygen needs, thymosin-α-1 (Tα1) treatment showed a trend towards improved clinical recovery compared to standard care, although the differences were not statistically significant.

Tα1 treatment significantly increased CD4+ T cell counts in patients requiring low-flow oxygen by day 5, indicating a potential mechanism for its efficacy in enhancing immune response in COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection. Shehadeh, F., Benitez, G., Mylona, EK., et al.[2023]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Thymalfasin: an immune system enhancer for the treatment of liver disease. [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

Thymalfasin: an immune system enhancer for the treatment of liver disease. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Thymalfasin: clinical pharmacology and antiviral applications. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Thymosin alpha 1 for the adjuvant treatment of coronavirus disease 2019: a retrospective cohort study]. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of thymalfasin plus transarterial chemoembolization for unresectable hepatocellular carcinoma. [2023]

6. India pubmed.ncbi.nlm.nih.gov

A Double-blind Multicenter Two-arm Randomized Placebo-controlled Phase-III Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α1 as an Add-on Treatment to Existing Standard of Care Treatment in Moderate-to-severe COVID-19 Patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection. [2023]