Evaluating a new COVID-19 mRNA vaccine for safety and immune response
A Randomised, Blinded, Parallel-controlled Phase 1 Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of a COVID-19 mRNA Vaccine in Healthy Adult Subjects
This study is testing a new COVID-19 mRNA vaccine to see if it's safe and how well it helps healthy adults build immunity against the virus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | CNBG-Virogin Biotech (Shanghai) Ltd. Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06113744 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial is designed to assess the safety and preliminary immunogenicity of a COVID-19 mRNA vaccine in healthy adults aged 18 and older. Participants will be randomly assigned to different age and dose groups, receiving either a single or double dose of the vaccine. The study will also include an active control group receiving an inactivated COVID-19 vaccine. A total of 164 subjects will be enrolled to evaluate the immune response and safety profile of the vaccine.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 years and older who have not been previously vaccinated against COVID-19 or have not had a recent COVID-19 infection.
Not a fit: Patients who are currently pregnant, breastfeeding, or have had more than three doses of a COVID-19 vaccine may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a new and effective option for preventing COVID-19 infection.
How similar studies have performed: Other studies evaluating mRNA vaccines for COVID-19 have shown promising results, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy male or female subjects aged ≥18 years of age; 2. Subjects who are in good physical condition as judged by the investigator based on medical history, physical examination and clinical laboratory tests; 3. Subjects who have not been previously vaccinated with a Covid-19 vaccine or who have received the last dose (total dose ≤ 3 doses) of a Covid-19 vaccine at least 6 months ago; 4. Subjects who have not been previously infected with Covid-19, or whose nucleic acid or antigen test has turned negative for more than 1 month after previous Covid-19 infection; 5. Subjects who have used effective contraception since 2 weeks prior to enrolment; 6. Subjects or their delegates are able to understand the study procedures, have provide written informed consent, and are able to comply with the requirements of the clinical study protocol. Exclusion Criteria: 1. Females of childbearing potential who have a positive pregnancy test, are pregnant, breastfeeding, or planning to become pregnant within 12 months; males: whose spouse is planning to become pregnant within 1 year; 2. History of epilepsy, convulsions or seizures, psychosis or family history of psychosis; 3. Subjects who were using antipyretic, analgesic or anti-allergic drugs within 3 days before enrolment; 4. Have a previous history of severe allergy to any medication or vaccination (e.g. acute allergic reaction, urticaria, skin eczema, dyspnoea, angioneurotic oedema, or abdominal pain) or allergy to known components of a Covid-19 vaccine; 5. Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders; 6. Have a history of hospital-diagnosed known immunological impairment or hypofunction; 7. Subjects who have received immunoenhancement or immunosuppressant therapy (continuous use by oral or infusion for more than 14 days) within 3 months, and whole blood, plasma, or immunoglobulin within 1 month; 8. Known or suspected concomitant serious diseases, including: respiratory diseases, acute infections or active chronic diseases, liver and kidney diseases, severe diabetes, malignant tumours, infectious or allergic skin diseases, cardiovascular disease, and HIV infection (with test report); 9. Subjects suffering from various acute diseases or in the acute exacerbation of chronic diseases within 3 days before vaccination; 10. Subjects with clinically significant abnormalities in blood biochemistry, blood routine, urine routine, coagulation function, thyroid function, and myocarditis-related indicators detected during the screening; 11. Received live attenuated vaccine within 1 month before vaccination; 12. Received inactivated vaccine within 14 days before vaccination; 13. Axillary temperature ≥37.3℃; 14. Who have participated in other clinical trials within 3 months prior to the first dose of vaccination or plan to participate in other clinical trials during the study period; 15. Other conditions that the investigator deems inappropriate for participation in this clinical trial.
Where this trial is running
Hangzhou, Zhejiang
- Shulan (Hangzhou) Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Guiling Chen
- Email: chenguiling707@126.com
- Phone: 86-18343113983
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.