SARS-CoV-2NCT05492643
The Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine
A study testing one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006), Cellular Immunity and Humoral Immunity in people with SARS-CoV-2 and Safety, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study plans to enrol 1000 participants 18 years and above, with ≥10% participants ≥60 years old. According to SARS-CoV-2 vaccine vaccination history, they will be evenly divided into 2 groups, Group A and Group B. 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, Safety, Immunotoxicity
- What is being tested?
- one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006), Cellular Immunity and Humoral Immunity
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2022to 1 Mar 2023
- Phase
- Interventional
- 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
- Adults aged 18 years and older;
- Vaccinated with 2 or 3 doses of marketed inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago;
- Willing and able to comply with study requirements, and other study procedures within 6 months after vaccination;
- Female participants or partners of male participants of childbearing potential: from the first day of last menstruation cycle to the day of enrolment, must had no sexual behavior with a male or had effective contraceptive methods without failure; voluntarily agree to maintain abstinent or use effective contraception with their partners until 6 months after vaccination;
- Based on medical history enquiry, physical examination, and blood routine examination, the investigator judges the participants as in a healthy status; Participants with mild underlying disease (for example chonic diseases like diabetes/hypertension/hyperlipemia, etc.) must be in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study.
- Understand the contents of the ICF and voluntarily sign it.
Who cannot join
- 1.Received any licensed SARS-CoV-2 vaccines other than inactivated SARS-CoV-2 vaccine).
- 2.History of Severe Acute Respiratory Syndrome (SARS), or SARS-CoV-2 infections.
- 3.History of allergy to any component of the study vaccine or history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal oedema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
- 4.Positive SARS-CoV-2 RT-PCR results. 5.Axillary temperature ≥37.3°C at enrolment or 24 hours prior to vaccination. 6.Had a history of Human Immuno-deficiency Virus(HIV) infection or positive HIV test result before enrolment.
- 7.A history or family history of convulsions, epilepsy, encephalopathy and psychosis.
- 8.Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period.
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- 9.With severe or un-controllable cardiovascular disease, thrombotic disease, neurological disease, blood and lymphatic system disease, liver and kidney disease, respiratory system disease, metabolic, skeletal muscular disease and autoimmune disease.
- 10.Congenital or functional splenic deficiency, complete or partial splenectomy for any reason.
- 11.Prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, ≥20 mg/d prednisone or equivalent; however, inhaled and topical steroids are permitted) within 6 months prior to the vaccine.
- 12.Any other inactivated vaccines given within 7 days prior to the study vaccination, or live-attenuated vaccines within 14 days prior to the study vaccination.
- 13.Have received immunoglobulin or other blood products within 3 months prior to enrollment or plan to receive them during the study period.
- 14.Blood donation or blood loss ≥ 450 mL within 1 month prior to enrolment, or planned donation during the study period.
- 15.Is currently in or intent to participate in another clinical study at any time during the conduct of this study.
- 16.For Women of Childbearing Potential (WOCBP): with a positive urine pregnancy test before vaccination; pregnant or lactating; or have a plan to become pregnant within 6 months after enrolment. For male participants whose partner is WOCBP: whose partner has a plan to become pregnant within 6 months after her partner's enrolment.
- 17.With a history of intramuscular injection contraindication. For example: diagnosed thrombocytopenia, and coagulation disorder or received anticoagulation therapy.
- 18.Participants deemed unsuitable for participation in this study based on the investigator's assessment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430072
Xinghuan Wang, znyylcsy@126.com
Jianying Huang, znyylcsy@126.com
About this study
Official title: A Single Center, Open Label Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine
This study plans to enrol 1000 participants 18 years and above, with ≥10% participants ≥60 years old. According to SARS-CoV-2 vaccine vaccination history, they will be evenly divided into 2 groups, Group A and Group B.
Group A: will enrol 500 participants who have received 2 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment.
Read more
Group B: will enrol 500 participants who have received 3 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment.
The study is devided into two stages, the first stage will enrol 200 participants with 100 in Group A and 100 in Group B. They will undergo laboratory examination, immunogenicity observation and safety observation. The first 30 participants in each group will take extra cellular immune testing; the second stage will enrol the remaining 800 participants for safety observation.
Read the detailed description
All participants: all the 1000 participants enrolled will undergo safety observation.
Immunogenicity Subgroup: the first 100 participants enrolled in group A will be assigned to Group A1; the first 100 participants enrolled in group B will be assigned to Group B1. Blood samples will be taken from Group A1 and Group B1 participants (200 in total) for humoral immunity testing and laboratory examination.
Laboratory examination include blood routine examination, urine routine test, blood biochemistry, coagulation, thyroid function, cardiac enzymes and troponin.
Humoral immunity testing include serum SARS-CoV-2 neutralizing antibody detection as measured by live virus and pseudovirus assay, S1 protein specific IgG binding antibody detection as measured by ELISA.
Cellular immunity Subgroup: the first 30 participants enrolled in Group A1 and Group B1 will take extra blood samples for specific cellular immune response (60 in total) as measured by ELISpot.
- Conditions
- SARS-CoV-2, Safety, Immunotoxicity
- Being tested
- one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006), Cellular Immunity, Humoral Immunity, Safety
- Keywords
- SARS-CoV-2, Vaccine, Safety, Immunotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006)Biological
all the 1000 participants enrolled will be given one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006)
Cellular ImmunityOther
the first 30 participants enrolled in each group will take extra blood samples for specific cellular immune response as measured by ELISpot.
Humoral ImmunityOther
the first 100 participants enrolled in each group will take extra blood samples for humoral immunity testing and laboratory examination.
SafetyOther
all the 500 participants enrolled will undergo safety observation
| Study group | Role | What they receive |
|---|---|---|
| Group A：2 doses of inactivated SARS-CoV-2 vaccine | Experimental | Group A: will enrol 500 participants who have received 2 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. Receives: Biological: one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006); Other: Cellular Immunity; Other: Humoral Immunity; Other: Safety |
| Group B：3 doses of inactivated SARS-CoV-2 vaccine | Experimental | Group B: will enrol 500 participants who have received 3 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. Receives: Biological: one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006); Other: Cellular Immunity; Other: Humoral Immunity; Other: Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
- Solicited (local and systemic) adverse events (within 14 days after vaccination) and unsolicited adverse events (within 30 days after vaccination);
- Serious Adverse Events (SAE) (within 6 months after vaccination);
- Adverse events of special interest (AESI) (within 6 months after vaccination);
- Abnormal laboratory examination (4 days after vaccination).
Measured: 6 months
Primary Immunogenicity Endpoint
Geometric Mean Titer (GMT), Geometric Mean Increase (GMI), Seroconversion (SCR) of SARS-CoV-2 live virus neutralizing antibody (14 days, 30 days post vaccination)
Measured: 6 months
Secondary outcomes (3)
GMT、GMI、SCR of SARS-CoV-2 pseudovirus neutralizing antibody
1.To evaluate the immunogenicity of one dose of SYS6006 mRNA vaccine as heterologous booster in participants aged 18 years and older who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccine as measured by pseudovirus neutralizing antibody.
Measured: 14 days, 30 days post vaccination
GMT、GMI、SCR of SARS-CoV-2 S1 protein specific binding IgG antibody
2.To evaluate the immunogenicity of one dose of SYS6006 mRNA vaccine as heterologous booster in participants aged 18 years and older who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccine as measured by S1 protein specific IgG binding antibody.
Measured: 14 days, 30 days post vaccination
GMT、GMI、SCR of SARS-CoV-2 live virus, pseudovirus neutralizing antibody and S1 protein specific IgG antibody
3.To evaluate the immuno-persistency of one dose of SYS6006 mRNA vaccine as heterologous booster in participants aged 18 years and older who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccine as measured by SARS-CoV-2 live virus neutralizing antibody, pseudovirus antibody and S1 protein specific IgG binding antibody.
Measured: 3 months, 6 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start13 Aug 2022
- Primary completion27 Feb 2023 (estimated)
- Study completion1 Mar 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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinghuan Wang, Principal investigator, Wuhan UniversityJianying Huang, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492643
- Sponsor's protocol ID
- SYS6006-007
- Status last verified
- Jul 2022
- First submitted
- 4 Aug 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine
- ClinicalTrials.gov ID
- NCT05492643
- Acronym / sponsor ID
- SYS6006-007
- Conditions
- SARS-CoV-2, Safety, Immunotoxicity
- Keywords
- SARS-CoV-2, Vaccine, Safety, Immunotoxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 13 Aug 2022 (actual)
- Primary completion
- 27 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 8 Aug 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 study plans to enrol 1000 participants 18 years and above, with ≥10% participants ≥60 years old. According to SARS-CoV-2 vaccine vaccination history, they will be evenly divided into 2 groups, Group A and Group B.
Group A: will enrol 500 participants who have received 2 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment.
Group B: will enrol 500 participants who have received 3 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment.
The study is devided into two stages, the first stage will enrol 200 participants with 100 in Group A and 100 in Group B. They will undergo laboratory examination, immunogenicity observation and safety observation. The first 30 participants in each group will take extra cellular immune testing; the second stage will enrol the remaining 800 participants for safety observation.
Detailed description
All participants: all the 1000 participants enrolled will undergo safety observation.
Immunogenicity Subgroup: the first 100 participants enrolled in group A will be assigned to Group A1; the first 100 participants enrolled in group B will be assigned to Group B1. Blood samples will be taken from Group A1 and Group B1 participants (200 in total) for humoral immunity testing and laboratory examination.
Laboratory examination include blood routine examination, urine routine test, blood biochemistry, coagulation, thyroid function, cardiac enzymes and troponin.
Humoral immunity testing include serum SARS-CoV-2 neutralizing antibody detection as measured by live virus and pseudovirus assay, S1 protein specific IgG binding antibody detection as measured by ELISA.
Cellular immunity Subgroup: the first 30 participants enrolled in Group A1 and Group B1 will take extra blood samples for specific cellular immune response (60 in total) as measured by ELISpot.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A：2 doses of inactivated SARS-CoV-2 vaccine | Experimental | Biological: one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006), Other: Cellular Immunity, Other: Humoral Immunity, Other: SafetyGroup A: will enrol 500 participants who have received 2 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. |
| Group B：3 doses of inactivated SARS-CoV-2 vaccine | Experimental | Biological: one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006), Other: Cellular Immunity, Other: Humoral Immunity, Other: SafetyGroup B: will enrol 500 participants who have received 3 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years and older;
- Vaccinated with 2 or 3 doses of marketed inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago;
- Willing and able to comply with study requirements, and other study procedures within 6 months after vaccination;
- Female participants or partners of male participants of childbearing potential: from the first day of last menstruation cycle to the day of enrolment, must had no sexual behavior with a male or had effective contraceptive methods without failure; voluntarily agree to maintain abstinent or use effective contraception with their partners until 6 months after vaccination;
- Based on medical history enquiry, physical examination, and blood routine examination, the investigator judges the participants as in a healthy status; Participants with mild underlying disease (for example chonic diseases like diabetes/hypertension/hyperlipemia, etc.) must be in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study.
Key exclusion criteria (16 listed)
- 1.Received any licensed SARS-CoV-2 vaccines other than inactivated SARS-CoV-2 vaccine).
- 2.History of Severe Acute Respiratory Syndrome (SARS), or SARS-CoV-2 infections.
- 3.History of allergy to any component of the study vaccine or history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal oedema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
- 4.Positive SARS-CoV-2 RT-PCR results. 5.Axillary temperature ≥37.3°C at enrolment or 24 hours prior to vaccination. 6.Had a history of Human Immuno-deficiency Virus(HIV) infection or positive HIV test result before enrolment.
- 7.A history or family history of convulsions, epilepsy, encephalopathy and psychosis.
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 |
|---|---|---|
| one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006)all the 1000 participants enrolled will be given one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006) | Biological | Group A：2 doses of inactivated SARS-CoV-2 vaccine, Group B：3 doses of inactivated SARS-CoV-2 vaccine |
| Cellular Immunitythe first 30 participants enrolled in each group will take extra blood samples for specific cellular immune response as measured by ELISpot. | Other | Group A：2 doses of inactivated SARS-CoV-2 vaccine, Group B：3 doses of inactivated SARS-CoV-2 vaccine |
| Humoral Immunitythe first 100 participants enrolled in each group will take extra blood samples for humoral immunity testing and laboratory examination. | Other | Group A：2 doses of inactivated SARS-CoV-2 vaccine, Group B：3 doses of inactivated SARS-CoV-2 vaccine |
| Safetyall the 500 participants enrolled will undergo safety observation | Other | Group A：2 doses of inactivated SARS-CoV-2 vaccine, Group B：3 doses of inactivated SARS-CoV-2 vaccine |
Primary outcome
Primary Safety Endpoint
Time frame: 6 months
* Solicited (local and systemic) adverse events (within 14 days after vaccination) and unsolicited adverse events (within 30 days after vaccination); * Serious Adverse Events (SAE) (within 6 months after vaccination); * Adverse events of special interest (AESI) (within 6 months after vaccination); * Abnormal laboratory examination (4 days after vaccination).
Primary Immunogenicity Endpoint
Time frame: 6 months
Geometric Mean Titer (GMT), Geometric Mean Increase (GMI), Seroconversion (SCR) of SARS-CoV-2 live virus neutralizing antibody (14 days, 30 days post vaccination)
3 secondary outcomes
GMT、GMI、SCR of SARS-CoV-2 pseudovirus neutralizing antibody
Time frame: 14 days, 30 days post vaccination
GMT、GMI、SCR of SARS-CoV-2 S1 protein specific binding IgG antibody
Time frame: 14 days, 30 days post vaccination
GMT、GMI、SCR of SARS-CoV-2 live virus, pseudovirus neutralizing antibody and S1 protein specific IgG antibody
Time frame: 3 months, 6 months post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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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.
Xinghuan Wang principal investigator
Wuhan University
Jianying Huang principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006), Cellular Immunity and Humoral Immunity in people with SARS-CoV-2 and Safety, run by Zhongnan Hospital 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 16 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 12 Oct 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jianying Huang (67812668, znyylcsy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 6 months). 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 12 Oct 2022.