SARS-CoV-2 InfectionPhase 2NCT05439824
A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Participants Aged 18 Years or More
A Phase 2 study testing SYS6006 20 μg and SYS6006 30 μg in people with SARS-CoV-2 Infection, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites in China.
Trial summary
This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006）in healthy participants aged 18 or more. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- SYS6006 20 μg and SYS6006 30 μg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 2 sitesChina
- Study dates
- 28 Jun 2022to 28 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age at the time of the first dose of vaccine: 18 and above;
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
- Based on the medical history, physical examination and laboratory examination results, the investigator clinically determined the qualified person.
- Has independent judgment, and participate voluntarily and sign an informed consent form.
Who cannot join
- Those who meet any of the following criteria must be excluded from this study:
- Has a history of SARS or SARS-CoV-2 infection, or close contact with SARS-CoV-2 infected person( nucleic acid test positive), or living abroad within 30 days before screening;
- Positive for SARS-CoV-2 antibody test;
- History of allergy to paracetamol or vaccination (such as acute allergic reaction, urticaria, dyspnea, angioedema, or abdominal pain);
- Has a history of vaccination with SARS-CoV-2 vaccine, or vaccination with other inactivated or recombinant vaccine within 7 days or received live attenuated vaccine within 14 days before the first dose;
- Has a medical or family history of epilepsy or convulsion, neurological disorders, mental disorders, etc.;
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- Is contraindications for intramuscular injection, such as diagnosed thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc.;
- Has known or suspected serious disorders judged by the Investigator, including but not limited to respiratory disorders (pulmonary failure, etc.), liver and kidney disorders, cardiovascular disorders (cardiac failure, severe hypertension, etc.), malignant tumors, infections or allergic skin disorders, HIV infection, or in the acute infection or chronic disease activity period (within 3 days before vaccination);
- Has chronic diseases (such as Down syndrome, sickle cell anemia, neurological disorders and Guillain-Barre syndrome, excluding chronic diseases such as controlled stable diabetes mellitus/hypertension/hyperlipidemia) that are not suitable for this study at the discretion of the Investigator;
- Has known immunological impairment or immunodeficiency diagnosed by hospital before enrollment, or functional asplenia or splenectomy caused by any condition;
- For women of childbearing potential: positive pregnancy test before the enrollment, being in pregnant, breastfeeding, or have a pregnancy plan within 1 year; men: whose spouses is of childbearing potential and has a pregnancy plan within 1 year;
- Is participating or plan to participate in other clinical studies during the study;
- Has received immune enhancement or immunosuppressive therapy within 3 months (continuous oral or instillation for more than 14 days); or received treatment with whole blood, plasma and immunoglobulin within 1 month;
- Is unlikely to adhere to the study procedures or keep appointments at the discretion of the investigators;or has other conditions that are not suitable for participating in this clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sir Run Run Hosipital Nanjing Medical University
Nanjing, Jiangsu
Hebei Provincial Center For Disease Control and Prevention
Shijiazhuang, Hebei, 050024
About this study
Official title: A Randomized, Observer-blinded, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Immunogenicity and Safety of a SARS-CoV-2 mRNA Vaccine (SYS6006) in Healthy Participants Aged 18 Years or More
This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006）in healthy participants aged 18 or more.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- SYS6006 20 μg, SYS6006 30 μg, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6006 20 μgBiological
SARS-CoV-2 mRNA Vaccine
SYS6006 30 μgBiological
SARS-CoV-2 mRNA Vaccine
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 20 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) | Experimental | 20μg dose of SYS6006 vaccine IM, on day 0 and day 21. Receives: Biological: SYS6006 20 μg |
| 30 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) | Experimental | 30 μg dose of SYS6006 vaccine IM, on day 0 and day 21. Receives: Biological: SYS6006 30 μg |
| Placebo(Aged 18~59 years or 60 years or more) | Placebo comparator | placebo IM, on day 0 and day 21 . Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Measured: 14 days after the second dose
Adverse events (AEs), including solicited AEs and unsolicited AEs
Measured: From the first dose through 30 days following the second dose
AEs associated with the study intervention
Measured: From the first dose through 30 days following the second dose
Secondary outcomes (5)
Serious adverse events (SAEs)
Measured: from the first dose through 12 months after the second dose.
Adverse events of special interest (AESIs)
Measured: rom the first dose through 12 months after the second dose.
Laboratory test related adverse events
Measured: 4 days following each dose.
Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Measured: from the first dose through 21 days
GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Measured: 30, 90, 180 and 360 days after the second dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start28 Jun 2022
- Primary completion12 Jan 2023
- Study completion28 Jun 2023 (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.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuliang Zhao, Principal investigator, Center For Disease Control and Prevention, Hebei ProvinceJingxin Li, Principal investigator, Jiangsu Province Centers for Disease Control and PreventionXiang Lu, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439824
- Sponsor's protocol ID
- SYS6006-003
- Status last verified
- May 2023
- First submitted
- 27 Jun 2022
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-blinded, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Immunogenicity and Safety of a SARS-CoV-2 mRNA Vaccine (SYS6006) in Healthy Participants Aged 18 Years or More
- ClinicalTrials.gov ID
- NCT05439824
- Acronym / sponsor ID
- SYS6006-003
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 28 Jun 2023 (estimated)
- First posted
- 30 Jun 2022 (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.
This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006）in healthy participants aged 18 or more.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) | Experimental | Biological: SYS6006 20 μg20μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
| 30 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) | Experimental | Biological: SYS6006 30 μg30 μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
| Placebo(Aged 18~59 years or 60 years or more) | Placebo comparator | Biological: Placeboplacebo IM, on day 0 and day 21 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age at the time of the first dose of vaccine: 18 and above;
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
- Based on the medical history, physical examination and laboratory examination results, the investigator clinically determined the qualified person.
- Has independent judgment, and participate voluntarily and sign an informed consent form.
Key exclusion criteria (14 listed)
- Those who meet any of the following criteria must be excluded from this study:
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 |
|---|---|---|
| SYS6006 20 μgSARS-CoV-2 mRNA Vaccine | Biological | 20 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) |
| SYS6006 30 μgSARS-CoV-2 mRNA Vaccine | Biological | 30 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) |
| PlaceboPlacebo | Biological | Placebo(Aged 18~59 years or 60 years or more) |
Primary outcome
Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Time frame: 14 days after the second dose
Adverse events (AEs), including solicited AEs and unsolicited AEs
Time frame: From the first dose through 30 days following the second dose
AEs associated with the study intervention
Time frame: From the first dose through 30 days following the second dose
5 secondary outcomes
Serious adverse events (SAEs)
Time frame: from the first dose through 12 months after the second dose.
Adverse events of special interest (AESIs)
Time frame: rom the first dose through 12 months after the second dose.
Laboratory test related adverse events
Time frame: 4 days following each dose.
Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Time frame: from the first dose through 21 days
GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Time frame: 30, 90, 180 and 360 days after the second dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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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.
Yuliang Zhao principal investigator
Center For Disease Control and Prevention, Hebei Province
Jingxin Li principal investigator
Jiangsu Province Centers for Disease Control and Prevention
Xiang Lu principal investigator
Nanjing Medical University
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 SYS6006 20 μg and SYS6006 30 μg in people with SARS-CoV-2 Infection, run by CSPC ZhongQi Pharmaceutical Technology Co., 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 4 inclusion and 14 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 24 May 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. 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody (time frame: 14 days after the second dose). The study lists 3 primary outcomes in all. 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 24 May 2023.