This study is a randomized, double-blind, placebo controlled clinical exploratory studyto evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthyadults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipidnanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Upto one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) isfor 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 intramuscularinjection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscularinjection respectively. Participants are randomized to receive TI-0010 or placebo in a4:1 ratio.
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.
Biological: TI-0010
Sterile liquid for injection
Biological: Placebo
0.9% sodium chloride (normal saline) injection
Inclusion Criteria:
- 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 Criteria:
- 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
The Second Affiliated Hospital Of BengBu Medical College
Bengbu, Anhui, China
Investigator: Xiaoli Li, Master
Contact: 15215520890
158169847@qq.com
Xiaoli li, Master
15215520890
158169847@qq.com
Xiaoli Li, Master, Principal Investigator
The Second Affiliated Hospital of Bengbu Medical College