SARS-CoV-2Phase 1NCT05354089
A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.
A Phase 1 study testing 20 μg dose of SYS6006 and 30 μg dose of SYS6006 in people with SARS-CoV-2, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites in China.
Trial summary
This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity and immune persistence of SYS6006 (SARS-CoV-2 mRNA Vaccine) in 18-59 year old healthy population. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- 20 μg dose of SYS6006 and 30 μg dose of SYS6006
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 27 Apr 2022to 1 Oct 2023
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age at the time of the first dose of vaccine: 18 to 59 years;
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
- Based on the medical history and relevant physical examination and laboratory examination results (normal or abnormal but no clinical significance), the investigator clinically determined that the patient was in good health;
- Has independent judgment, and participate voluntarily and sign an informed consent form.
Who cannot join
- Has a history of SARS-CoV or SARS-CoV-2 infection, or close contact with SARS-CoV-2 infected persons (nucleic acid test positive) or living abroad within 30 days before screening;
- Positive SARS-CoV-2 antibody test;
- Previous history of allergy to acetaminophen or vaccination(eg, acute allergic reaction, urticaria, dyspnea, angioneurotic edema, or abdominal pain);
- Has a history of COVID-19 vaccination, or have received other inactivated or recombinant vaccines within 7 days, or received live attenuated vaccines within 14 days,before the first dose;
- Has a medical history or family history of epilepsy, convulsions, neurological diseases and psychiatric diseases;
- Is contraindicative for intramuscular injection，such as: diagnosed thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;
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- 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 stably controlled diabetes/hypertension) that are not suitable for this study at the discretion of the Investigator;
- Has known immunocompromised conditions diagnosed in hospital before enrollment, or functional aspleen or splenectomy caused by any condition;
- For women of childbearing potential: positive pregnancy test, being in pregnancy or breastfeeding, or have a pregnancy plan within one year;men: whose spouses is of childbearing potential and has a pregnancy plan within 1 year;
- Is participating in other clinical trials or plan to participate in other clinical trials during the study period;
- Has received immune enhancement or immunosuppressive therapy within 3 months before the first dose of vaccine (continuous oral or instillation for more than 14 days); or received whole blood, plasma and immunoglobulin therapy within one month;
- Is unlikely to adhere to the study procedures or keep appointments at the discretion of the investigators;or plan to permanently relocate before the end of study; or plan to leave the resident location for a long time at the scheduled visit; or has any other conditions that are inappropriate for participation for this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shulan(hangzhou) Hospital
Hangzhou, Zhejiang
Sir Run Run Hosipital Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of a SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.
This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity and immune persistence of SYS6006 (SARS-CoV-2 mRNA Vaccine) in 18-59 year old healthy population.
- Conditions
- SARS-CoV-2
- Being tested
- 20 μg dose of SYS6006, 30 μg dose of SYS6006, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 μg dose of SYS6006Biological
20 μg dose of SYS6006 vaccine IM on day 0 and day 21.
30 μg dose of SYS6006Biological
30 μg dose of SYS6006 vaccine IM on day 0 and day 21.
PlaceboDrug
Placebo IM on day 0 and day 21.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine group 1 | Experimental | 20 μg dose of SYS6006 vaccine IM, on day 0 and day 21. Receives: Biological: 20 μg dose of SYS6006 |
| Vaccine group 2 | Experimental | 30 μg dose of SYS6006 vaccine IM, on day 0 and day 21. Receives: Biological: 30 μg dose of SYS6006 |
| Placebo | Placebo comparator | Placebo IM, on day 0 and day 21. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, including solicited and unsolicited events
Measured: From the first dose through 30 days following the second dose.
adverse events associated with the study intervention
Measured: From the first dose through 30 days following the second dose.
Secondary outcomes (4)
Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody)
Measured: 14 days after the first dose; 7 days, 14 days, 30 days, 90 days, 180 days and 360 days after the second dose
Serious adverse events (SAE)
Measured: from the first dose through 12 months after the second dose.
Adverse events of special interest (AESI)
Measured: from the first dose through 12 months after the second dose.
Laboratory test related adverse events
Measured: 4 days following each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start27 Apr 2022
- Primary completion9 Jul 2022
- Study completion1 Oct 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-2Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lanjuan Li, Principal investigator, Shulan (Hangzhou) HospitalGuiling Chen, Principal investigator, Shulan (Hangzhou) HospitalXiang Lu, Principal investigator, Sir Run Run Hosipital Nanjing Medical UniversityYuwen Su, Principal investigator, Sir Run Run Hosipital Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354089
- Sponsor's protocol ID
- SYS6006-001
- Status last verified
- May 2023
- First submitted
- 28 Apr 2022
- Last updated
- 24 May 2023
- Results posted
- No
- 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 Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of a SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.
- ClinicalTrials.gov ID
- NCT05354089
- Acronym / sponsor ID
- SYS6006-001
- Conditions
- SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 29 Apr 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 I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity and immune persistence of SYS6006 (SARS-CoV-2 mRNA Vaccine) in 18-59 year old healthy population.
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 |
|---|---|---|
| Vaccine group 1 | Experimental | Biological: 20 μg dose of SYS600620 μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
| Vaccine group 2 | Experimental | Biological: 30 μg dose of SYS600630 μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo IM, on day 0 and day 21. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age at the time of the first dose of vaccine: 18 to 59 years;
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
- Based on the medical history and relevant physical examination and laboratory examination results (normal or abnormal but no clinical significance), the investigator clinically determined that the patient was in good health;
- Has independent judgment, and participate voluntarily and sign an informed consent form.
Key exclusion criteria (13 listed)
- Has a history of SARS-CoV or SARS-CoV-2 infection, or close contact with SARS-CoV-2 infected persons (nucleic acid test positive) or living abroad within 30 days before screening;
- Positive SARS-CoV-2 antibody test;
- Previous history of allergy to acetaminophen or vaccination(eg, acute allergic reaction, urticaria, dyspnea, angioneurotic edema, or abdominal pain);
- Has a history of COVID-19 vaccination, or have received other inactivated or recombinant vaccines within 7 days, or received live attenuated vaccines within 14 days,before the first dose;
- Has a medical history or family history of epilepsy, convulsions, neurological diseases and psychiatric diseases;
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 |
|---|---|---|
| 20 μg dose of SYS600620 μg dose of SYS6006 vaccine IM on day 0 and day 21. | Biological | Vaccine group 1 |
| 30 μg dose of SYS600630 μg dose of SYS6006 vaccine IM on day 0 and day 21. | Biological | Vaccine group 2 |
| PlaceboPlacebo IM on day 0 and day 21. | Drug | Placebo |
Primary outcome
Adverse events, including solicited and unsolicited events
Time frame: From the first dose through 30 days following the second dose.
adverse events associated with the study intervention
Time frame: From the first dose through 30 days following the second dose.
4 secondary outcomes
Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody)
Time frame: 14 days after the first dose; 7 days, 14 days, 30 days, 90 days, 180 days and 360 days after the second dose
Serious adverse events (SAE)
Time frame: from the first dose through 12 months after the second dose.
Adverse events of special interest (AESI)
Time frame: from the first dose through 12 months after the second dose.
Laboratory test related adverse events
Time frame: 4 days following each 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.
Lanjuan Li principal investigator
Shulan (Hangzhou) Hospital
Guiling Chen principal investigator
Shulan (Hangzhou) Hospital
Xiang Lu principal investigator
Sir Run Run Hosipital 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 1 study testing 20 μg dose of SYS6006 and 30 μg dose of SYS6006 in people with SARS-CoV-2, 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 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 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 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?
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?
Adverse events, including solicited and unsolicited events (time frame: From the first dose through 30 days following the second dose.). The study lists 2 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.