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

SARS-CoV-2 Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113731
• Other study ID #: ZSVG-02-O-2022-P2
• Status: Recruiting
• Phase: Phase 2
• Start date: July 10, 2023
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: CNBG-Virogin Biotech (Shanghai) Ltd.
• Contact: Yanxia Wang
• Phone: +86-13613816598
• Email: wangyanxia99[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 980
• Est. completion date: October 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• COVID-19 mRNA Vaccine (ZSVG-02-O)
30 µg
• COVID-19 mRNA Vaccine (ZSVG-02-O)
60 µg
• COVID-19 Vaccine (Vero Cell) ,Inactivated
COVILO

Locations

Country	Name	City	State
China	Dengfeng Centre for Disease Control and Prevention and Control	Dengfeng	Henan
China	Henan Provincial Centre for Disease Control and Prevention	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
CNBG-Virogin Biotech (Shanghai) Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in cytokine levels in Th1/Th2 cells induced by S protein	Cytokine [IFN-?, interleukin(IL)-4, IL-2] levels in Th1/Th2 cells changed from pre-dose to 28 days after the full immunisation	From before the first dose of immunisation to 28 days after full immunisation
Other	Cross-neutralisation against different SARS-CoV-2 variants	The cross-neutralization effect of the mRNA vaccine (Omicron strain) against different SARS-CoV-2 variants (ancestral strain, Omicron strain and main circulating strain)	From the first dose of immunisation to 28 days after full immunisation
Primary	Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination	Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination	28 days after full immunisation
Secondary	GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 14 days after full vaccination	GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 14 days after full vaccination	14 days after full immunisation
Secondary	GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 7 days after the first immunisation	GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 7 days after the first immunisation	7 days after the first immunisation
Secondary	Proportion of NAbs against SARS-CoV-2 titres=1:16, =1:32 and =1:64 on 14 and 28 days after full immunisation	Proportion of NAbs against SARS-CoV-2 titres=1:16, =1:32 and =1:64 on 14 and 28 days after full immunisation	14 days and 28 days after full immunisation
Secondary	GMT, 4-fold increasing rate and ratio of antibody titres =1:16, =1:32 and =1:64 for NAbs against SARS-CoV-2 on 90 and 180 days after full immunisation	GMT, 4-fold increasing rate and ratio of antibody titres =1:16, =1:32 and =1:64 for NAbs against SARS-CoV-2 on 90 and 180 days after full immunisation	90 days and 180 days after full immunisation
Secondary	Incidence and severity of adverse event (AE) within 30 minutes of each dose of vaccination	Incidence and severity of AE within 30 minutes of each dose of vaccination	From the start of each immunisation until 30 minutes after each immunisation
Secondary	Incidence and severity of adverse reactions/events 0-14 days after each dose of vaccination	Incidence and severity of adverse reactions/events 0-14 days after each dose of vaccination	Day 0~Day 14 after each immunisation
Secondary	Incidence and severity of adverse reactions/events 15-28 days after each dose of vaccination	Incidence and severity of adverse reactions/events 15-28 days after each dose of vaccination	Day 15~Day 28 after each immunisation
Secondary	Incidence of serious adverse event (SAE) from the start of vaccination to 12 months after full vaccination	Incidence of SAE from the start of vaccination to 12 months after full vaccination	From the first dose of immunisation to 12 months after full immunisation