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

Testing the safety of a new COVID-19 vaccine in healthy adults.

Recruiting
18-59 years
All
Phase 1

This study is testing a new vaccine, called TI-0010, for COVID-19 in healthy adults aged 18-59. COVID-19 is a disease caused by the virus SARS-CoV-2. The vaccine is made by a company named Therorna Inc. and uses a special method called lipid nanoparticles (LNP), which are tiny particles that help deliver the vaccine into the body. Researchers want to see if the vaccine is safe and if it helps the body fight the virus.

People in the study will be split into groups called cohorts. Some will get a low dose and others a high dose. They will either get one or two shots in the arm. The study is randomized, meaning some people will get the vaccine and some will get a placebo, which is a fake shot. The study will check on participants' health several times over a year.

  • Study lasts for about a year, with multiple follow-up visits.
  • Participants must be 18-59 years old and healthy.
  • There are risks, such as possible side effects from the vaccine.

Participants cannot join if they recently had COVID-19, are pregnant, or have certain health issues. They must also not have had a COVID-19 vaccine recently.

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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FAQs

Learn more about clinical trials

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.

Why should I take part in a clinical trial?

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

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

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

How safe are clinical trials?

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