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An open experimental design was used in this study, and 240 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential intensification in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
One dose of recombinant novel coronavirus vaccine (CHO cell) for test was injected into the upper arm deltoid muscle muscle of the subject
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 1 dose of the test recombinant novel coronavirus vaccine (CHO cell) was injected into the deltoid muscle of the subject's upper arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Novel Coronavirus vaccine (CHO Cells) | Biological | The experimental vaccine dose used in this study is 25μg/0.5mL. All subjects recruited should have received two doses of novel Coronavirus inactivated vaccine on the market for 6-9 months, and all eligible subjects will receive one dose of recombinant Novel Coronavirus vaccine (CHO cells). |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-COV-2 neutralizing antibody | Titers of SARS-COV-2 neutralizing Antibody at 14 days and 6 months after vaccination of recombinant Novel Coronavirus vaccine (CHO cells) (GMT) | 14 days and 6 months after inoculation |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-COV-2 neutralizing antibody | GMI and 4-fold increase in SARS-COV-2 neutralizing antibody at 14 days and 6 months after intensification of recombinant Novel Coronavirus vaccine (CHO cells) | 14 days and 6 months after inoculation |
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Inclusion Criteria:
Exclusion Criteria:
History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection;
SARS virus disease history or SARS-COV-2 history;
Have taken antipyretics or painkillers within 24 hours before vaccination;
Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angiopantic edema, etc.;
Persons suffering from the following diseases:
Subunit vaccine and inactivated vaccine should be administered within 14 days before experimental vaccine, and live attenuated vaccine should be administered within 30 days before experimental vaccine;
Have received blood or blood-related products, including immunoglobulin, within 3 months prior to the trial vaccine; Or planned for use during the study period;
People aged 3-17 years who have participated in or are participating in other COVID-19 related clinical trials or have received other COVID-19 vaccines, except those who have completed two doses of marketed Novel Coronavirus inactivated vaccine within 6-9 months;
Pregnant (including positive urine pregnancy), or breast-feeding; The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center for Disease Control and Prevention | Changsha | Hunan | 410005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38641791 | Derived | Huang T, Hu Q, Zhou X, Yang H, Xia W, Cao F, Deng M, Teng X, Ding F, Zhong Z, Gao L, Sun J, Gong L. Immunogenicity and safety of a recombinant COVID-19 vaccine (ZF2001) as heterologous booster after priming with inactivated vaccine in healthy children and adolescents aged 3-17 years: an open-labeled, single-arm clinical trial. BMC Infect Dis. 2024 Apr 19;24(1):413. doi: 10.1186/s12879-024-09293-1. |
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|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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