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this is a voluntary, investigator-initiated, inactivated COVID-19 vaccine controlled clinical trial to evaluate the immunogenicity and safety of COVID-19 mRNA vaccine in adults aged 18 years and above which have immunized with two dose of inactivated COVID-19 vaccine at least 6 months ago.
A total of 112 participants will be enrolled in the study. All the participants have immunized with two doses of inactivated COVID-19 vaccine at least 6 months ago. The 98 participants will be inoculated with one dose COVID-19 messenger ribonucleic acid(mRNA) vaccine from Stemirna Therapeutics Co., Ltd and the others will be inoculated with one dose inactivated COVID-19 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS). Before the inoculation, 14 days and 28 days after the immunization, blood samples will be taken for determination of neutralizing antibody and immunoglobulin G(IgG) antibody against severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) N protein and S protein (enzyme-linked immuno sorbent assay, ELISA method); and before the inoculation and 28 days after the immunization, blood samples will be taken for detecting specific T cells with the enzyme-linked immunospot(ELISPOT) assay with an aim to evaluate immunogenicity. Safety observations for all participants will be conducted from the inoculation to 28 days, and follow-up of severe adverse events (SAEs) will also be conducted from inoculation to at least 12 months to evaluate the safety of the investigational vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-Cov-2 mRNA vaccine immunization group | Experimental | The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd. |
|
| Inactivated SARS-Cov-2 vaccine immunization group | Experimental | The 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-Cov-2 mRNA vaccine immunization | Biological | The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd and . |
|
| Measure | Description | Time Frame |
|---|---|---|
| the geometric mean titer (GMT) of neutralizing antibody | the geometric mean titer (GMT) of neutralizing antibody against SARS-Cov-2 14 days and 28 days after vaccine inoculation | 14 days and 28 days |
| the incident of solicited adverse events(AEs) | the incident of solicited AEs at the inoculation (local) and solicited AEs at the non-inoculation (systemic) within 7 days after immunization. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Titer (GMT) of IgG antibody | The Geometric Mean Titer (GMT) of IgG antibody against SARS-CoV-2 N protein and S protein (ELISA method) 14 days and 28 days after vaccine inoculation | 14 days and 28 days |
| Specific T cells with ELISPOT assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Inactivated SARS-Cov-2 vaccine immunization | Biological | The 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS). |
|
Detecting specific T cells with ELISPOT assay 28 days after vaccine inoculation |
| 28 days |
| The incidence of AEs | The incidence of AEs from the inoculation to 28 days after the immunization. | 28 days |
| The incidence of SAEs | The incidence of AEs from the inoculation to at least 12 months after the immunization. | 1 year |