COVID-19Phase 2NCT04813562
Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)
A Phase 2 study testing a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56, a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56 and a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56 in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56, a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56 and a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2021to 30 Jul 2022
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects of ≥ 18 years old.
- The subject can understand and voluntarily sign the informed consent.
- Axillary temperature ≤37.0℃.
- General good health as established by medical history and physical examination
Who cannot join
- Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
- Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
- Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
- In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
- Have a history of SARS.
- Have a history of SARS-CoV-2 infection or history of Coronavirus Vaccination (including Emergency Vaccine and Experimental Vaccine).
Show all 30Show fewer
- Positive in SARS-CoV-2 IgG or IgM antibody screening.
- Have a history of HIV infection;
- Women who are breastfeeding, pregnant, or planning to become pregnant during 6 months after full-course vaccination (based on the subject's self-report and blood pregnancy test results for women of childbearing age).
- Have a history of asthma, a history of vaccine or vaccine component allergy, have serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
- Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
- Subjects with severe chronic diseases, severe cardiovascular diseases, hypertension(sbp≥160mmHg and/or dbp≥100mmHg) and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.
- Subjects with severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
- Subjects with thyroid disease or history of thyroidectomy, no spleen, functional asthenia, and any spleen or splenectomy caused by any condition.
- Abnormal blood coagulation function diagnosed by a doctor (such as coagulation factor deficiency, coagulopathy, abnormal platelet) or obvious bruise or coagulation disorder.
- Have received immunosuppressant therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis).
- Received blood products within 3 months before receiving trial vaccine.
- Received other study drugs within 30 days before receiving the trail vaccine.
- Received a live attenuated vaccine within 14 days before receiving the experimental vaccine.
- Received a subunit or inactivated vaccine within 7 days before receiving the experimental vaccine.
- Various acute or chronic diseases occurred in the past 7 days.
- Have a long history of alcohol or drug abuse.
- Had urticaria one year before receiving the experimental vaccine;
- congenital or acquired angioedema/neuroedema;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial, or Or influence the subject to sign the informed consent.
- Patients with severe allergic reactions after the previous dose of vaccination;
- Patients with serious adverse reactions causally related to the previous dose of vaccination.
- For those newly discovered or newly discovered after the first vaccination that does not meet the first-dose selection criteria or meets the first-dose exclusion criteria, the investigator will determine whether to continue participating in the study.
- Other exclusion reasons suggested by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu
Mingwei Wei, 15950529760, wnmcwmw@163.com
About this study
Official title: A Single-center, Randomized, Double Blinded, Placebo Controlled, Phase 2 Clinical Trial of Recombinant COVID-19 Vaccine (CHO Cells), in the Subjects From Healthy Aged 18 Years and Above
This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).
Read the detailed description
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 480 in total.
Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.
- Conditions
- COVID-19
- Being tested
- a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56, a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56, a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56, a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56, a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56
- Keywords
- Immunogenicity, Safety, COVID-19 vaccine, Recombinant vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56Biological
18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56Biological
18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56Biological
60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56Biological
60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56Biological
18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56Biological
18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56Biological
60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56Biological
60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
| Study group | Role | What they receive |
|---|---|---|
| Middle-dose vaccine (18-59 years) | Experimental | Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56 Receives: Biological: a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56 |
| High-dose vaccine (18-59 years) | Experimental | Two doses of High-dose vaccine at the schedule of day 0, 28, 56 Receives: Biological: a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56 |
| Middle-dose vaccine (60-85 years) | Experimental | Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56 Receives: Biological: a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56 |
| High-dose vaccine (60-85 years) | Experimental | Two doses of High-dose experimental vaccine at the schedule of day 0, 28, 56 Receives: Biological: a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56 |
| Middle-dose placebo (18-59 years) | Placebo comparator | Three doses of middle-dose placebo at the schedule of day 0, 28, 56 Receives: Biological: a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56 |
| High-dose placebo (18-59 years) | Placebo comparator | Two doses of High-dose placebo at the schedule of day 0, 28, 56 Receives: Biological: a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56 |
| Middle-dose placebo (60-85 years) | Placebo comparator | Three doses of middle-dose placebo at the schedule of day 0, 28, 56 Receives: Biological: a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56 |
| High-dose placebo (60-85 years) | Placebo comparator | Two doses of High-dose placebo at the schedule of day 0, 28, 56 Receives: Biological: a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
Measured: 30 days after full-course vaccination in each study group
The incidence of adverse reaction (AR)
Measured: 0 to 7 days after vaccination in each study group
Secondary outcomes (9)
The incidence of adverse events (AE)
Measured: 0 to 30 days after vaccination in each study group
The incidence of severe adverse events (SAE)
Measured: 12 months after prime and boost vaccination
The Geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)
Measured: 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group
The Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)
Measured: 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
Measured: 14 days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (pseudovirus neutralization assays)
Measured: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Measured: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The GMT of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Measured: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The GMI of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Measured: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start23 Mar 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- 307 Hospital of PLA
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Doctor, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813562
- Sponsor's protocol ID
- JSVCT097
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016.
PubMed 36103390
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double Blinded, Placebo Controlled, Phase 2 Clinical Trial of Recombinant COVID-19 Vaccine (CHO Cells), in the Subjects From Healthy Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT04813562
- Acronym / sponsor ID
- JSVCT097
- Conditions
- COVID-19
- Keywords
- Immunogenicity, Safety, COVID-19 vaccine, Recombinant vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- 307 Hospital of PLA
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 24 Mar 2021 (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 Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).
Detailed description
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 480 in total.
Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Middle-dose vaccine (18-59 years) | Experimental | Biological: a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56 |
| High-dose vaccine (18-59 years) | Experimental | Biological: a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56Two doses of High-dose vaccine at the schedule of day 0, 28, 56 |
| Middle-dose vaccine (60-85 years) | Experimental | Biological: a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56 |
| High-dose vaccine (60-85 years) | Experimental | Biological: a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56Two doses of High-dose experimental vaccine at the schedule of day 0, 28, 56 |
| Middle-dose placebo (18-59 years) | Placebo comparator | Biological: a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56Three doses of middle-dose placebo at the schedule of day 0, 28, 56 |
| High-dose placebo (18-59 years) | Placebo comparator | Biological: a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56Two doses of High-dose placebo at the schedule of day 0, 28, 56 |
| Middle-dose placebo (60-85 years) | Placebo comparator | Biological: a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56Three doses of middle-dose placebo at the schedule of day 0, 28, 56 |
| High-dose placebo (60-85 years) | Placebo comparator | Biological: a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56Two doses of High-dose placebo at the schedule of day 0, 28, 56 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects of ≥ 18 years old.
- The subject can understand and voluntarily sign the informed consent.
- Axillary temperature ≤37.0℃.
- General good health as established by medical history and physical examination
Key exclusion criteria (30 listed)
- Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
- Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
- Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
- In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
- Have a history of SARS.
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 |
|---|---|---|
| a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 5618-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. | Biological | Middle-dose vaccine (18-59 years) |
| a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 5618-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. | Biological | High-dose vaccine (18-59 years) |
| a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 5660-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. | Biological | Middle-dose vaccine (60-85 years) |
| a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 5660-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. | Biological | High-dose vaccine (60-85 years) |
| a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 5618-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56. | Biological | Middle-dose placebo (18-59 years) |
| a high-dose placebo (18-59 years) at the schedule of day 0, 28, 5618-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56. | Biological | High-dose placebo (18-59 years) |
| a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 5660-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56. | Biological | Middle-dose placebo (60-85 years) |
| a high-dose placebo (60-85 years) at the schedule of day 0, 28, 5660-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56. | Biological | High-dose placebo (60-85 years) |
Primary outcome
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
Time frame: 30 days after full-course vaccination in each study group
The incidence of adverse reaction (AR)
Time frame: 0 to 7 days after vaccination in each study group
9 secondary outcomes
The incidence of adverse events (AE)
Time frame: 0 to 30 days after vaccination in each study group
The incidence of severe adverse events (SAE)
Time frame: 12 months after prime and boost vaccination
The Geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)
Time frame: 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group
The Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)
Time frame: 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
Time frame: 14 days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (pseudovirus neutralization assays)
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The GMT of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The GMI of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 36103390Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016.
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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.
Fengcai Zhu, Doctor principal investigator
Jiangsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56, a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56 and a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56 in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention 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 4 inclusion and 30 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 31 Mar 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. 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?
Contact Fanyue Meng, Doctor (18915999245, mfy19780712@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays) (time frame: 30 days after full-course vaccination in each study group). 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 NCT04813562, which also lists 1 linked publication.
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 31 Mar 2022.