A Phase 1 Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine

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

A randomised, blinded, parallel-controlled phase 1 clinical trial to evaluate the safety and preliminary immunogenicity of a COVID-19 mRNA vaccine in a healthy population aged 18 years and older, and to investigate immunisation doses.

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Biological: COVID-19 Vaccine (Vero Cell) ,Inactivated; Biological: Placebo; Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg; Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg; Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg

Detailed Description

The phase 1 clinical trial is conducted in a randomised, blinded, parallel-controlled design to assess the safety, immunogenicity and immune persistence. Subjects will be divided into two age groups (18-59 and ≧60 years of age), and within the groups, subjects will be subdivided into three dose groups (10 μg,30 μg and 60 μg). The immunisation procedure is divided into one-dose group and two-dose group (0, 28 days).

The total sample size is 164 subjects. 12 subjects will be assigned to each group according to different age, dose and immunisation procedure, respectively. In addition, 20 subjects (10 aged 18-59 years and 10 aged ≧60 years) will be enrolled as active control and vaccinated with 2 doses of inactivated Covid vaccine (Vero cell) (0, 28 days).

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guiling Chen; Phone Number: 86-18343113983; Email: chenguiling707@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Shulan (Hangzhou) hospital
      • Contact: Guiling Chen; Phone Number: 86-18343113983; Email: chenguiling707@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose test vaccine, 1 dose	Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg; Low-dose
Experimental: Mid-dose test vaccine, 1 dose	Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg; Mid-dose
Experimental: High-dose test vaccine, 1 dose	Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg; High-dose
Placebo Comparator: Placebo, 1 dose	Biological: Placebo; saline
Experimental: Low-dose test vaccine, 2 dose	Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg; Low-dose
Experimental: Mid-dose test vaccine, 2 dose	Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg; Mid-dose
Experimental: High-dose test vaccine, 2 dose	Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg; High-dose
Placebo Comparator: Placebo, 2 doses	Biological: Placebo; saline
Active Comparator: Active control vaccine, 2 doses	Biological: COVID-19 Vaccine (Vero Cell) ,Inactivated; COVILO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and frequency of adverse event (AE)	Incidence of local/systemic adverse reactions/events 0-14 days and 15-28 days after each dose of vaccination, and incidence of solicited adverse events within 14 days after each dose of vaccination	Day 0~Day 28 after each dose of vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
4-fold increasing rate, GMT and GMI of NAbs against SARS-CoV-2 on 90, 180 and 360 days after full immunisation	4-fold increasing rate, GMT and GMI of NAbs against SARS-CoV-2 on 90, 180 and 360 days after full immunisation	Day 90~Day 360 after full immunisation
Number and frequency of serious adverse event (SAE)	Incidence of SAE from the first dose up to 12 months after full immunisation	From the first dose of immunisation to 12 months after full immunisation
4-fold increasing rate, geometric mean titre (GMT) and geometric mean increase (GMI) of neutralizing antibodies (Nabs) against SARS-CoV-2 on 14 days and 28 days after full immunisation	4-fold increasing rate, GMT and GMI of neutralizing antibody (Nabs) against SARS-CoV-2 on 14 days and 28 days after full immunisation	From the first dose of immunisation to 28 days after full immunisation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cytokine levels in Th1/Th2 cells induced by S protein	Cytokine (IFN-γ, 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

Collaborators and Investigators

• Sponsor: CNBG-Virogin Biotech (Shanghai) Ltd.
• Collaborators: Shulan (Hangzhou) Hospital
• Investigators: Study Chair: Yunkai Yang, China National Biotec Group Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: ZSVG-02-O-2022-P1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No