NCT06113731

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.

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
980

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

July 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 day 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
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 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 6, 2023

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 14 days after full vaccination

    14 days after full 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

  • 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

  • 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

  • Incidence and severity of adverse event (AE) within 30 minutes of each dose of vaccination

    From the start of each immunisation until 30 minutes after each immunisation

  • +3 more secondary outcomes

Other Outcomes (2)

  • 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

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

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

Study Arms (6)

Test vaccine dose 1, 2 dose

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

Test vaccine dose 2, 2 dose

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

Active Comparator, 2 dose

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

Test vaccine dose 1, 1 dose

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

Test vaccine dose 2, 1 dose

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

Active Comparator,1 dose

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

Interventions

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

30 μg

Test vaccine dose 1, 1 doseTest vaccine dose 1, 2 dose
COVID-19 Vaccine (Vero Cell) ,InactivatedBIOLOGICAL

COVILO

Active Comparator, 2 doseActive Comparator,1 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 3 months after previous Covid-19 infection;
  • 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.

You may not qualify if:

  • Axillary temperature ≥37.3°C;
  • Positive polymerase chain reaction (PCR) test results within the last 48 hours;
  • 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;
  • History of epilepsy, convulsions or seizures, psychosis or family history of psychosis;
  • 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;
  • 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 whole blood, plasma or immunoglobulin therapy within 3 months;
  • 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);
  • 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);
  • Received live attenuated vaccine within 1 month prior to vaccination or other vaccines within 14 days prior to vaccination;
  • 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;
  • Any other conditions that the investigator considers inappropriate for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dengfeng Centre for Disease Control and Prevention and Control

Songyang, Henan, China

RECRUITING

Henan Provincial Centre for Disease Control and Prevention

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccineCOVID-19 Vaccines

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

Yanxia Wang

CONTACT

+86-13613816598wangyanxia99@163.com

Study Design

Study Type
interventional
Phase
phase 2
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

July 10, 2023

Primary Completion

October 30, 2023

Study Completion

October 1, 2024

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

CN(2)