Status:
RECRUITING
A Study to Evealuate Safety and Immunogenicity of TI-0010 SARS-CoV-2 Vaccine in Healthy Adults
Lead Sponsor:
National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
Collaborating Sponsors:
Therorna
Conditions:
COVID-19
COVID-19 Immunisation
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06205524
Start Date
July 10 2023
End Date
February 1 2025
Last Update
January 18 2024
Active Locations (1)
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1
The Second Affiliated Hospital Of BengBu Medical College
Bengbu, Anhui, China, 233002