SARS-CoV-2 InfectionPhase 2NCT06113731
A PhaseⅡ Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine
A Phase 2 study testing COVID-19 mRNA Vaccine (ZSVG-02-O) and COVID-19 Vaccine (Vero Cell) ,Inactivated in people with SARS-CoV-2 Infection, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- COVID-19 mRNA Vaccine (ZSVG-02-O) and COVID-19 Vaccine (Vero Cell) ,Inactivated
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jul 2023to Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Dengfeng Centre for Disease Control and Prevention and Control
Songyang, Henan
Shuaixu Guo, 86-18697308288, dfscdcxmb@163.com
- Recruiting
Henan Provincial Centre for Disease Control and Prevention
Zhengzhou, Henan
Yanxia Wang, +8613613816598, wangyanxia99@163.com
About this study
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
To evaluate the immunogenicity and safety of a COVID-19 mRNA vaccine (ZSVG-02-O) in a healthy population aged 18 years and older.
Read the 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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- COVID-19 mRNA Vaccine (ZSVG-02-O), COVID-19 Vaccine (Vero Cell) ,Inactivated
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 mRNA Vaccine (ZSVG-02-O)Biological
30 μg
COVID-19 mRNA Vaccine (ZSVG-02-O)Biological
60 μg
COVID-19 Vaccine (Vero Cell) ,InactivatedBiological
COVILO
| Study group | Role | What they receive |
|---|---|---|
| Test vaccine dose 1, 2 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) |
| Test vaccine dose 2, 2 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) |
| Active Comparator, 2 dose | Active comparator | Not described Receives: Biological: COVID-19 Vaccine (Vero Cell) ,Inactivated |
| Test vaccine dose 1, 1 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) |
| Test vaccine dose 2, 1 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) |
| Active Comparator,1 dose | Active comparator | Not described Receives: Biological: COVID-19 Vaccine (Vero Cell) ,Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 14 days after full vaccination
Measured: 14 days after full immunisation
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
Measured: 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
Proportion of NAbs against SARS-CoV-2 titres≥1:16, ≥1:32 and ≥1:64 on 14 and 28 days after full immunisation
Measured: 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
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
Measured: 90 days and 180 days after full immunisation
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
Measured: From the start of each immunisation until 30 minutes after each immunisation
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
Measured: Day 0~Day 14 after each immunisation
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
Measured: Day 15~Day 28 after each immunisation
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
Measured: From the first dose of immunisation to 12 months after full immunisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start10 Jul 2023
- Primary completion30 Oct 2023
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yunkai Yang, Study chair, China National Biotec Group Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113731
- Sponsor's protocol ID
- ZSVG-02-O-2022-P2
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06113731
- Acronym / sponsor ID
- ZSVG-02-O-2022-P2
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the immunogenicity and safety of a COVID-19 mRNA vaccine (ZSVG-02-O) in a healthy population aged 18 years and older.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 mRNA Vaccine (ZSVG-02-O)30 μg | Biological | Test vaccine dose 1, 1 dose, Test vaccine dose 1, 2 dose |
| COVID-19 mRNA Vaccine (ZSVG-02-O)60 μg | Biological | Test vaccine dose 2, 1 dose, Test vaccine dose 2, 2 dose |
| COVID-19 Vaccine (Vero Cell) ,InactivatedCOVILO | Biological | Active Comparator, 2 dose, Active Comparator,1 dose |
Primary outcome
Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination
Time frame: 28 days after full immunisation
Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination
8 secondary outcomes
GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 14 days after full vaccination
Time frame: 14 days after full immunisation
GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 7 days after the first immunisation
Time frame: 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
Time frame: 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
Time frame: 90 days and 180 days after full immunisation
Incidence and severity of adverse event (AE) within 30 minutes of each dose of vaccination
Time frame: From the start of each immunisation until 30 minutes after each immunisation
Incidence and severity of adverse reactions/events 0-14 days after each dose of vaccination
Time frame: Day 0~Day 14 after each immunisation
Incidence and severity of adverse reactions/events 15-28 days after each dose of vaccination
Time frame: Day 15~Day 28 after each immunisation
Incidence of serious adverse event (SAE) from the start of vaccination to 12 months after full vaccination
Time frame: From the first dose of immunisation to 12 months after full immunisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunkai Yang study chair
China National Biotec Group Company Limited
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVID-19 mRNA Vaccine (ZSVG-02-O) and COVID-19 Vaccine (Vero Cell) ,Inactivated in people with SARS-CoV-2 Infection, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanxia Wang (+86-13613816598, wangyanxia99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination (time frame: 28 days after full immunisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.