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

Last updated: January 15, 2024
Sponsor: National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
Overall Status: Active - Recruiting

Phase

1

Condition

Covid-19

Treatment

Placebo

TI-0010

Clinical Study ID

NCT06205524
TI-0010-10102
  • Ages 18-59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipid nanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Up to one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) is for Cohort 1 and Cohort 2 , and the high dose (Dose Level 2) for Cohort 3 and Cohort 4. Cohort 1 and Cohort 3 receive 2 doses (with a 28 day interval) via intramuscular injection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscular injection respectively. Participants are randomized to receive TI-0010 or placebo in a 4:1 ratio.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Understands and agrees to comply with the study procedures and provides writteninformed consent.
  • Participant shall be in good general health within the age range of 18 to 59 years oldwhen signing ICF, and can comply with study procedures
  • For participant of childbearing potential: negative pregnancy test, adequatecontraception or has abstained from all activities that could result in pregnancyafter signing ICF, agreement to continue adequate contraception through 3 monthsfollowing vaccine administration, and not currently breastfeeding.
  • Participants have not received any SARS-CoV-2 vaccine before screening; Or ifparticipants have previously received SARS-CoV-2 vaccination, who vaccinated at least 6 months from the last vaccination date.
  • Participant has tested positive or had COVID-infection related symptoms at least 4months prior to screening.

Exclusion

Exclusion Criteria:

  • Arm 2/4 only: Individuals haven't completed full vaccination schedule with anyapproved or investigational COVID-19 vaccines.
  • Individuals with clinically significant laboratory or ECG abnormalities at Screening.
  • BMI >30 kg/m2 or <18 kg/m2
  • Positive RT-PCR test for SARS-CoV-2 at the screening site
  • Known exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 5 days
  • Postive test for HBsAg or HCV
  • Participant is acutely ill 4 weeks prior to Day1, or feberile (body temperature noless than 37.3 Celcius 72 hours prior to or at Day 1
  • Has received systemic immunosuppressants or immune-modifying drugs for >14 days intotal within 6 months prior to Screenin or is anticipating the need forimmunosuppressive treatment at any time during participation in the study
  • Participation in a study of investigational drug/device 30 days prior to Screening
  • Individuals with a history of autoimmune disease or an active autoimmune diseaserequiring therapeutic intervention
  • History of sever adverse reaction associated with a vaccine and/or severe allergicreaction to any component of the study intervention(s)
  • Previous vaccination with any vaccine 28 days prior Screening
  • Receipt of blood/plasma products or immunoglobulin 3 months prior Screening
  • Other medical or psychiatric condition that may increase the risk of studyparticipation or, in the investigator's judgment, make the individual inappropriatefor the study

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
July 10, 2023
Estimated Completion Date:
February 01, 2025

Study Description

This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipid nanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Up to one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) is for Cohort 1 and Cohort 2 , and the high dose(Dose Level 2) for Cohort 3 and Cohort 4. Cohort 1 and Cohort 3 receive 2 doses (with a 28 day interval) via intramuscular injection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscular injection respectively. Participants are randomized to receive TI-0010 or placebo in a 4:1 ratio. Follow-up visits will occur Days 3,7,14 and 28 post each vaccination, as well as 3, 6, 9 and 12 months for the single dose recipients after vaccination and for those who receive two doses post the second vaccination. The primary objective is to evaluate the safety and tolerability of the TI-0010 vaccine in adults within 28 days post each vaccination. The secondary objective is to evaluate the humoral and cellular immune responses of the TI-0010 vaccine in adults after a single dose or two doses of vaccination, to evaluate the safety of the TI-0010 vaccine within 1 year after vaccination in the adult population and to evaluate the immune persistence of TI-0010 vaccine after a single dose and two doses of administration.

Connect with a study center

  • The Second Affiliated Hospital Of BengBu Medical College

    Bengbu, Anhui 233002
    China

    Active - Recruiting

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