Novel coronavirus infection (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant infection
Conditions
Interventions
Low dose:20 µg (Cohort 1 D0D28):Lateral deltoid muscle of upper arm
intramuscular injection
Low dose:20 µg (Cohort 2 D0):Lateral deltoid muscle of upper arm
High dose: 40 µg (Cohort 3 D0D28):Lateral deltoid muscle of upper arm
High dose: 40 µg (Cohort 4 D0):Lateral deltoid muscle of upper arm
Sponsors
The Second Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1.Consent to participate in the study by voluntarily signing an ICF approved by the Ethics Committee prior to the commencement of any research procedure; 2.A healthy male or female who can provide legal proof of identity and is between 18 and 59 years old (including the threshold) at the time of signing the ICF; 3.Clinical study participants have not received any SARS-CoV-2 vaccine (available or in development) prior to screening: or if clinical study participants have previously received SARS-CoV-2 vaccine (whether or not they have completed full vaccination), "6 months or more from the date of last dose at the time of screening" must be met; 4.Clinical study participants with a history of confirmed or suspected COVID-19 infection must be at least 4 months from the last positive antigen test or the end date of infection-related symptoms; 5.Clinical study participants are able to communicate well with the investigators and have the ability to understand and comply with the requirements of the clinical study; 6.Fertile men and women of reproductive age in clinical study participants volunteered to use effective contraceptive methods, including intrauterine or implantable contraceptive devices, oral contraceptives, injectable or embedded contraceptives, time-release local contraceptives, intrauterine devices (ids), condoms (men), diaphragms, cervical caps, etc., from signing the ICF until 3 months after completing 2 doses of vaccination.
Exclusion criteria
Exclusion criteria: 1.Cohort 2/4 only: Individuals haven't completed full vaccination schedule with any approved or investigational COVID-19 vaccines(appendix 4); 2.Those who do not meet the health standards in a comprehensive physical examination mainly include: (1) abnormal vital signs (resting pulse 100 times/min, systolic blood pressure =160 mmHg or diastolic blood pressure >=100 mmHg); (2) Body mass index 30 kg/m^2; (3) Laboratory examination indicators during the screening period meet the following criteria: 1) Blood routine: White blood cell (WBC) count >=13×10^9/L or ,=1.5×10^9/L, platelet (PLT) count =1.2× upper limit of normal range (ULN), creatinine (Cr) >1.5×ULN, total bilirubin (TBIL) >=1.5×ULN; 3) Urine routine: urinary protein >=2+; (4) Other conditions deemed unsuitable for participation in the study by the investigator based on clinical judgment such as medical history, physical examination and laboratory examination; 3.Positive RT-PCR test for SARS-CoV-2 at the screening site; 4.Known exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 5 days before screening; 5.Participant is acutely ill 4 weeks prior to Day 1, or feberile (body temperature no less than 37.3 Celcius) 72 hours prior to or at Day 1; 6.Postive test for HBsAg or HCV at screening; 7.Female participants who are pregnant or breastfeeding, or plan to be a sperm/egg donor during the study period (from the start of informed consent signing until 3 months after second dose of the TI-0010 vaccine); 8.Patients who experienced a history of allergic reactions to any vaccine or its excipients, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, and abdominal pain, or reported with Guillain-Barre Syndrome (GBS) after previous vaccinations; 9. Previous vaccination with any vaccine 28 days prior to first dose of TI-0010 vaccine administration, or plan to receive any vaccine other than TI-0010 vaccine during the study period; 10.Any previous interventional study instrument or therapy drug within 30 days prior to screening, or other study drug is being used, or for any other study drug, last treatment is within 5 half-lives (whichever is longer); 11.A history of severe bleeding, or extensive bleeding after intramuscular injection or venipuncture, or a history of ecchymosis, with inherited bleeding tendencies or coagulation disorders (such as cytokine defects, coagulation disorders, or platelet disorders); 12.Medical history or diagnosis of a disease impairing function of immune system, including carcinoma (except for skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., human immunodeficiency virus (HIV) infection), or an autoimmune disease that cannot be controlled, or being clinical unstable; 13.Any uncontrolled or unstable medical condition, such as thyroid diseases, cardiovascular diseases, nervous system diseases, mental diseases, blood and gonorrhea system diseases, liver and kidney diseases, metabolic and skeletal system diseases which in the opinion of the investigator, may confound the study results; 14.Asplenia or functional asplenia; 15.Patients who had undergone major surgery within 4 week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity analysis;Laboratory examination indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity 1: Delta, Omicron pseudovirus neutralizing activity (Compared with before vaccination, anti-SARS-CoV-2 mutant strains (Delta, Omicron) of pseudovirus neutralize and Geometric mean titers (GMT), Geometric Mean of the Increase from Baseline (GMI) and Seroconversion Rate (SCR) );Immunogenicity 2: Delta, Omicron specific binding antibodies (Compared with before vaccination, the Geometric mean titers (GMT), Geometric Mean of the Increase from Baseline (GMI) and Seroconversion Rate (SCR) of SARS-CoV-2 receptor binding domain (RBD) protein specific IgG antibodies (Delta, Omicron) were measured);Immunogenicity 3: Cellular immunity (Compared with before vaccination, the proportion of four intracellular factors (interleukin [IL] -2, IL-4, interferon gamma [IFN - ?], tumor necrosis factor alpha [TNF - a]) in T lymphocyte subsets (CD4+, CD8+) and memory T cell subsets (CD4+, CD8+));Safety (Incidence of unsolicited adverse events );Safety (Incidence of serious adverse events (SAEs), AE of Special Interest (AESIs), and Medically-attended Aes (MAAEs) ); | — |
Countries
China
Contacts
Public ContactXiaoli Li
The Second Affiliated Hospital of Bengbu Medical College/The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed