SARS-CoV-2 InfectionPhase 1NCT06113744
A Phase 1 Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine
A Phase 1 study testing COVID-19 Vaccine (Vero Cell) ,Inactivated, COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg and COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg in people with SARS-CoV-2 Infection, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 1 site in China.
Trial 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. 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 Vaccine (Vero Cell) ,Inactivated, COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg and COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to Jun 2024
- Phase
- Phase 1
- 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 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang
Guiling Chen, 86-18343113983, chenguiling707@126.com
About this study
Official title: 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.
Read the 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).
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Placebo, COVID-19 Vaccine (Vero Cell) ,Inactivated, COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg, COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg, COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
saline
COVID-19 Vaccine (Vero Cell) ,InactivatedBiological
COVILO
COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μgBiological
Low-dose
COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μgBiological
Mid-dose
COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μgBiological
High-dose
| Study group | Role | What they receive |
|---|---|---|
| Low-dose test vaccine, 1 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg |
| Mid-dose test vaccine, 1 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg |
| High-dose test vaccine, 1 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg |
| Placebo, 1 dose | Placebo comparator | Not described Receives: Biological: Placebo |
| Low-dose test vaccine, 2 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg |
| Mid-dose test vaccine, 2 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg |
| High-dose test vaccine, 2 dose | Experimental | Not described Receives: Biological: COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg |
| Placebo, 2 doses | Placebo comparator | Not described Receives: Biological: Placebo |
| Active control vaccine, 2 doses | 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.
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
Measured: Day 0~Day 28 after each dose of vaccination
Secondary outcomes (4)
Number and frequency of serious adverse event (SAE)
Incidence of SAE from the first dose up to 12 months after full immunisation
Measured: 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
Measured: From the first dose of immunisation to 28 days after full immunisation
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)
Measured: 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
Measured: Day 90~Day 360 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 Mar 2023
- Primary completion30 Jun 2023
- Study completionJun 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shulan (Hangzhou) Hospital
- Responsible party
- Sponsor
- Investigators
- Yunkai Yang, Study chair, China National Biotec Group Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113744
- Sponsor's protocol ID
- ZSVG-02-O-2022-P1
- 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 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
- ClinicalTrials.gov ID
- NCT06113744
- Acronym / sponsor ID
- ZSVG-02-O-2022-P1
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shulan (Hangzhou) Hospital
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- Jun 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 1 month after previous Covid-19 infection;
- Subjects who have used effective contraception since 2 weeks prior to enrolment;
Key exclusion criteria (15 listed)
- 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;
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 |
|---|---|---|
| Placebosaline | Biological | Placebo, 1 dose, Placebo, 2 doses |
| COVID-19 Vaccine (Vero Cell) ,InactivatedCOVILO | Biological | Active control vaccine, 2 doses |
| COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μgLow-dose | Biological | Low-dose test vaccine, 1 dose, Low-dose test vaccine, 2 dose |
| COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μgMid-dose | Biological | Mid-dose test vaccine, 1 dose, Mid-dose test vaccine, 2 dose |
| COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μgHigh-dose | Biological | High-dose test vaccine, 1 dose, High-dose test vaccine, 2 dose |
Primary outcome
Number and frequency of adverse event (AE)
Time frame: Day 0~Day 28 after each dose of vaccination
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
4 secondary outcomes
Number and frequency of serious adverse event (SAE)
Time frame: 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
Time frame: From the first dose of immunisation to 28 days after full immunisation
Cross-neutralisation against different SARS-CoV-2 variants
Time frame: 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
Time frame: Day 90~Day 360 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVID-19 Vaccine (Vero Cell) ,Inactivated, COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg and COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg in people with SARS-CoV-2 Infection, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 1 site 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 6 inclusion and 15 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 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Guiling Chen (86-18343113983, chenguiling707@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and frequency of adverse event (AE) (time frame: Day 0~Day 28 after each dose of vaccination). 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.