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

NCT06205524 | Unknown Phase 1

• 1 other identifier: TI-0010-10102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; COVID-19 Immunisation

Outcome Measures

Primary Outcomes (2)

• solicited adverse events (AEs)

  solicited adverse events (AEs)

  Up to 14 days following each injection among all participants.

• The incidence of abnormal changes in laboratory indicators (including blood routine, blood biochemistry, thyroid function, coagulation function, and urine routine. )

  The incidence of abnormal changes in laboratory indicators (including blood routine, blood biochemistry, thyroid function, coagulation function, and urine routine. )

  Up to 3 days following each injection among all participants.

Secondary Outcomes (9)

• Geometric mean titer(GMT) of SARS-CoV-2 neutralizing antibodies

  Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months

• Geometric mean titer fold increase(GMI) of SARS-CoV-2 neutralizing antibodies compared to baseline

  Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months

• Seroconversion rates(SCRs) of SARS-CoV-2 neutralizing antibodies

  Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months

• Geometric mean titer(GMT) of SARS-CoV-2 RBD-binding IgG

  Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months

• Geometric mean titer fold increase(GMI) of SARS-CoV-2 RBD-binding IgG compared to baseline

  Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months

Study Arms (4)

cohort 1

EXPERIMENTAL

Participants will receive 2 intramuscular (IM) injections of either TI-0010 or Placebo at Dose Level 1 on Day 0 and Day 28

Biological: TI-0010; Biological: Placebo

cohort 2

EXPERIMENTAL

Participants will receive 1 intramuscular (IM) injection of either TI-0010 or Placebo at Dose Level 1 on Day 0

Biological: TI-0010; Biological: Placebo

cohort 3

EXPERIMENTAL

Participants will receive 2 intramuscular (IM) injections of either TI-0010 or Placebo at Dose Level 2 on Day 0 and Day 28

Biological: TI-0010; Biological: Placebo

cohort 4

EXPERIMENTAL

Participants will receive 1 intramuscular (IM) injection of either TI-0010 or Placebo at Dose Level 2 on Day 0

Biological: TI-0010; Biological: Placebo

Interventions

TI-0010 BIOLOGICAL

Sterile liquid for injection

cohort 1; cohort 2; cohort 3; cohort 4

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

cohort 1; cohort 2; cohort 3; cohort 4

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understands and agrees to comply with the study procedures and provides written informed consent.
• Participant shall be in good general health within the age range of 18 to 59 years old when signing ICF, and can comply with study procedures
• For participant of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy after signing ICF, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
• Participants have not received any SARS-CoV-2 vaccine before screening; Or if participants 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 4 months prior to screening.

You may not qualify if:

• Arm 2/4 only: Individuals haven't completed full vaccination schedule with any approved 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 no less than 37.3 Celcius 72 hours prior to or at Day 1
• Has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screenin or is anticipating the need for immunosuppressive 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 disease requiring therapeutic intervention
• History of sever adverse reaction associated with a vaccine and/or severe allergic reaction 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 study participation or, in the investigator's judgment, make the individual inappropriate for the study

Sponsors & Collaborators

• National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College: lead
• Therorna: collaborator

Study Sites (1)

The Second Affiliated Hospital Of BengBu Medical College

Bengbu, Anhui, 233002, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaoli Li, Master

  The Second Affiliated Hospital of Bengbu Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli li, Master

CONTACT

15215520890; 158169847@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: an associate chief physician

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 16, 2024
• Study Start: July 10, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)