SARS-CoV-2Phase 1NCT05354063

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults.

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety and preliminary immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese healthy adults aged 60 years and over. Read more about this study

Who is it for?: Ages 60 years and olderHealthy 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: 1 Jun 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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 60 years or older;
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 SARS-CoV-2 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 having been diagnosed with thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy;

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Has known or suspected severe diseases by the judgement of investigators, including but not limited to: respiratory diseases (lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), malignant tumors, infections or allergic skin diseases, HIV infection, or during the acute infection or chronic disease activity period (within 3 days before vaccination).
Has chronic diseases which at the discretion of investigator are inappropriate for participation(such as Down 's syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome, etc., not including stable diabetes mellitus/hypertension);
Known immunological impairment or dysfunction diagnosed by the hospital before enrollment, or functional asplenia or splenectomy due to any condition;
For women of childbearing potential: positive pregnancy test, being in pregnancy or breastfeeding, or have a pregnancy plan within one year;male: their spouse of childbearing age has plans to become pregnant 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 Hospital Nanjing Medical University
Nanjing, Jiangsu

Other trials in China

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 SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 60 Years and Over.

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 groups in NCT05354063
Study group	Role	What they receive
Vaccine group 1	Experimental	20μg dose of SYS6006 vaccine IM, on day 0 and day 21. Receives: Biological: 20 μg dose of SYS6006
Vaccine group 2	Experimental	30μg 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.

1 Jun 20221 Oct 2023

First posted29 Apr 2022
Study start1 Jun 2022
Primary completion5 Sep 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05354063
Sponsor's protocol ID: SYS6006-002
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All SARS-CoV-2 trials

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 SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 60 Years and Over.
ClinicalTrials.gov ID: NCT05354063
Acronym / sponsor ID: SYS6006-002
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: 1 Jun 2022 (actual)
Primary completion: 5 Sep 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.

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 SYS600620μg dose of SYS6006 vaccine IM, on day 0 and day 21.
Vaccine group 2	Experimental	Biological: 30 μg dose of SYS600630μg 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: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 60 years or older;
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 SARS-CoV-2 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

Related trials for SARS-CoV-2

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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?

On the ClinicalTrials.gov record for NCT05354063.

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.