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NCT06113731 | RECRUITING | SARS-CoV-2 Infection

A PhaseⅡ Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine
Sponsor:

CNBG-Virogin Biotech (Shanghai) Ltd.

Brief Summary:

To evaluate the immunogenicity and safety of a COVID-19 mRNA vaccine (ZSVG-02-O) in a healthy population aged 18 years and older.

Condition or disease

SARS-CoV-2 Infection

Intervention/treatment

COVID-19 mRNA Vaccine (ZSVG-02-O)

COVID-19 mRNA Vaccine (ZSVG-02-O)

COVID-19 Vaccine (Vero Cell) ,Inactivated

Phase

PHASE2

Detailed Description:

This study uses a randomized, blinded and controlled design, with age stratification of 18-59 years and ≥60 years , including the test vaccine at different doses (30 μg and 60 μg) and an active control vaccine. A total of 980 subjects will be enrolled in this study. 490 subjects aged 18-59 years will be randomly assigned to cohort A1 (test vaccine dose 1), A2 (test vaccine dose 2) and A3 (control vaccine) for the 2-dose regimen (0,28-day) and to cohort A4 (test vaccine dose 1), A5 (test vaccine dose 2) and A6 (active control) for the 1-dose regimen in a ratio of 3:3:1:3:3:1. Another 490 subjects aged 60 years or older will be randomized to cohort B1 (test vaccine dose 1), B2 (test vaccine dose 2) and B3 (active control) for the 2-dose regimen (0,28-day), and cohort B4 (test vaccine dose 1), B5 (test vaccine dose 2) and B6 (control vaccine) for the 1-dose regimen in a ratio of 3:3:1:3:3:1.

Study Type : INTERVENTIONAL
Estimated Enrollment : 980 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
Official Title : A Randomized, Blinded, Controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a COVID-19 mRNA Vaccine (ZSVG-02-O) in a Healthy Population 18 Years of Age and Older
Actual Study Start Date : 2023-07-10
Estimated Primary Completion Date : 2023-10-30
Estimated Study Completion Date : 2024-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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 3 months after previous Covid-19 infection;
  • 5. Subjects 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. Axillary temperature ≥37.3°C;
  • 2. Positive polymerase chain reaction (PCR) test results within the last 48 hours;
  • 3. Women of childbearing potential with a positive urine pregnancy test result, or who are pregnant or breastfeeding, or who have not used effective contraception within 2 weeks prior to enrolment, or women and men who plan to have children within 12 months after full immunisation;
  • 4. History of epilepsy, convulsions or seizures, psychosis or family history of psychosis;
  • 5. Have a 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;
  • 6. Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
  • 7. Have a history of hospital-diagnosed known immunological impairment or hypofunction;
  • 8. Subjects who have received whole blood, plasma or immunoglobulin therapy within 3 months;
  • 9. 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, and HIV infection (with test report);
  • 10. Have serious cardiovascular diseases, cardiopulmonary failure, hypertension that cannot be controlled by medication (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg on physical examination);
  • 11. Received live attenuated vaccine within 1 month prior to vaccination or other vaccines within 14 days prior to vaccination;
  • 12. Participation in a clinical trial of another drug within 3 months prior to the first dose of vaccine or planning to participate in a clinical trial of another drug during the study period;
  • 13. Any other conditions that the investigator considers inappropriate for participation in this study.
A PhaseⅡ Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine

Location Details

NCT06113731

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How to Participate

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Locations

RECRUITING

China, Henan

Dengfeng Centre for Disease Control and Prevention and Control

Dengfeng, Henan, China,

RECRUITING

China, Henan

Henan Provincial Centre for Disease Control and Prevention

Zhengzhou, Henan, China,