Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205524
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-18
Brief Title:
A Study to Evealuate Safety and Immunogenicity of TI-0010 SARS-CoV-2 Vaccine in Healthy Adults
Sponsor:
National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
Organization:
National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
Study Overview
Official Title:
An Exploratory Randomized Double-Blind Dose-Ranging Study to Evaluate the Safety and Immunogenicity of TI-0010 Vaccine to Prevent COVID-19 Caused by SARS-CoV-2 in Healthy Adults Aged 18-59 Years
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-doseDose 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 41 ratio
Detailed 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-doseDose Level 1 is for Cohort 1 and Cohort 2 and the high doseDose 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 41 ratio Follow-up visits will occur Days 3714 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None