Evaluating the safety and immune response of a new COVID-19 vaccine in healthy adults
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
This study is testing a new COVID-19 vaccine in healthy adults to see if it is safe and how well it helps their immune system fight the virus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College Academic / other |
| Locations | 1 site (Bengbu, Anhui) |
| Trial ID | NCT06205524 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled exploratory study assessing the safety, tolerability, and immunogenicity of the TI-0010 vaccine in healthy adults aged 18-59. Participants will be divided into four cohorts receiving either a low or high dose of the vaccine or a placebo, with follow-up visits scheduled to monitor their health and immune response. The study aims to determine the vaccine's effectiveness in generating an immune response against SARS-CoV-2 and its safety profile over a year following vaccination.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 59 who have not received any SARS-CoV-2 vaccine prior to screening.
Not a fit: Patients who have recently been vaccinated against SARS-CoV-2 or have had COVID-19 symptoms within the last four months may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a new option for preventing COVID-19 in healthy adults.
How similar studies have performed: Other studies have shown success with similar vaccine approaches, indicating potential for this novel vaccine to be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bengbu, Anhui
- The Second Affiliated Hospital Of BengBu Medical College — Bengbu, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Xiaoli Li, Master — The Second Affiliated Hospital of Bengbu Medical College
- Study coordinator: Xiaoli li, Master
- Email: 158169847@qq.com
- Phone: 15215520890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.