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A Study to Evealuate Safety and Immunogenicity of TI-0010 SARS-CoV-2 Vaccine in Healthy Adults

Recruiting
18-59 years
Both
Phase 1

This study is testing a new COVID-19 vaccine called **TI-0010** in healthy adults aged 18-59. The vaccine uses **lipid nanoparticles (LNP)**, tiny fat particles, to carry a special type of RNA called **circRNA** that targets the virus. Up to 100 people will join in 4 groups. Some will get one shot, others will get two shots 28 days apart. The shots are given in the muscle. Participants will be randomly assigned to receive either the vaccine or a **placebo**, a harmless substance that doesn't contain the vaccine, in a 4:1 ratio. Visits will occur on days 3, 7, 14, and 28 after each dose and continue for up to a year to check safety and how well the vaccine works. The study aims to see if the vaccine is safe and helps the body fight COVID-19.

  • Participants will have follow-up visits up to 12 months after vaccination.
  • Participants must be healthy and between 18-59 years old.
  • This study is randomized, meaning some get the vaccine and some get a placebo.
Study details
    COVID-19
    COVID-19 Immunisation

NCT06205524

National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College

24 January 2024

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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