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

Launched by NATIONAL DRUG CLINICAL TRIAL INSTITUTE OF THE SECOND AFFILIATED HOSPITAL OF BENGBU MEDICAL COLLEGE · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called TI-0010, which is designed to help protect healthy adults from COVID-19. The main goals of the study are to see how safe the vaccine is and how well it can trigger the body's immune response against the virus. The trial involves healthy adults aged 18 to 59, and participants will be randomly assigned to receive either the vaccine or a placebo (a shot with no active vaccine) in a 4:1 ratio. Depending on the group they are in, participants may receive one or two doses of the vaccine over a period of time.

To be eligible for this trial, participants need to be generally healthy, not currently pregnant or breastfeeding, and should not have received any COVID-19 vaccine in the six months before the study. Other criteria include not having COVID-19 symptoms or exposure to the virus recently. Participants can expect to have regular check-ins to monitor their health and how they respond to the vaccine. This study is important because it aims to develop new ways to protect against COVID-19, especially as the virus continues to change.

Gender

ALL

Eligibility criteria

• 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