NCT06113744

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

October 31, 2023

Last Update Submit

November 7, 2023

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number and frequency of serious adverse event (SAE)

    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

    From the first dose of immunisation to 28 days after full immunisation

  • Cross-neutralisation against different SARS-CoV-2 variants

    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

    Day 90~Day 360 after full immunisation

Other Outcomes (1)

  • Changes in cytokine levels in Th1/Th2 cells induced by S protein

    From before the first dose of immunisation to 28 days after full immunisation

Study Arms (9)

Low-dose test vaccine, 1 dose

EXPERIMENTAL
Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg

Mid-dose test vaccine, 1 dose

EXPERIMENTAL
Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg

High-dose test vaccine, 1 dose

EXPERIMENTAL
Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg

Placebo, 1 dose

PLACEBO COMPARATOR
Biological: Placebo

Low-dose test vaccine, 2 dose

EXPERIMENTAL
Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg

Mid-dose test vaccine, 2 dose

EXPERIMENTAL
Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg

High-dose test vaccine, 2 dose

EXPERIMENTAL
Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg

Placebo, 2 doses

PLACEBO COMPARATOR
Biological: Placebo

Active control vaccine, 2 doses

ACTIVE COMPARATOR
Biological: COVID-19 Vaccine (Vero Cell) ,Inactivated

Interventions

PlaceboBIOLOGICAL

saline

Placebo, 1 dosePlacebo, 2 doses
COVID-19 Vaccine (Vero Cell) ,InactivatedBIOLOGICAL

COVILO

Active control vaccine, 2 doses
COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μgBIOLOGICAL

Low-dose

Low-dose test vaccine, 1 doseLow-dose test vaccine, 2 dose
COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μgBIOLOGICAL

Mid-dose

Mid-dose test vaccine, 1 doseMid-dose test vaccine, 2 dose
COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μgBIOLOGICAL

High-dose

High-dose test vaccine, 1 doseHigh-dose test vaccine, 2 dose

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female subjects aged ≥18 years of age;
  • Subjects who are in good physical condition as judged by the investigator based on medical history, physical examination and clinical laboratory tests;
  • 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;
  • 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;
  • Subjects who have used effective contraception since 2 weeks prior to enrolment;
  • 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.

You may not qualify if:

  • 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;
  • History of epilepsy, convulsions or seizures, psychosis or family history of psychosis;
  • Subjects who were using antipyretic, analgesic or anti-allergic drugs within 3 days before enrolment;
  • 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;
  • Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
  • Have a history of hospital-diagnosed known immunological impairment or hypofunction;
  • 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;
  • 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);
  • Subjects suffering from various acute diseases or in the acute exacerbation of chronic diseases within 3 days before vaccination;
  • Subjects with clinically significant abnormalities in blood biochemistry, blood routine, urine routine, coagulation function, thyroid function, and myocarditis-related indicators detected during the screening;
  • Received live attenuated vaccine within 1 month before vaccination;
  • Received inactivated vaccine within 14 days before vaccination;
  • Axillary temperature ≥37.3℃;
  • 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;
  • Other conditions that the investigator deems inappropriate for participation in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 VaccinesCVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Yunkai Yang

    China National Biotec Group Company Limited

    STUDY CHAIR

Central Study Contacts

Guiling Chen

CONTACT

86-18343113983chenguiling707@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 2, 2023

Study Start

March 10, 2023

Primary Completion

June 30, 2023

Study Completion

June 1, 2024

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

CN(1)