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COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. To further improve COVID-19 vaccine immunization strategy, we start the clinic research about sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine in Zhejiang province.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant adenovirus type-5-vectored COVID-19 vaccine | Experimental |
| |
| Inactivated COVID-19 vaccine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant adenovirus type-5-vectored COVID-19 vaccine | Biological | One dose COVID-19 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions (AR) in 0-14 days after immunization | Incidence of adverse reactions (AR) | 14 days |
| Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2 at 14 days after immunization | Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2 | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
5) Acute febrile disease, infectious disease, SARS history; 6) Axillary body temperature > 37.0℃; 7) Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured on site); 8) Patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) Congenital or acquired angioedema/neuroedema; 10) Urticaria 1 year before receiving the test vaccine; 11) No spleen or functional no spleen; 12) Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) History of novel coronavirus infection/illness; 14) Have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel Coronavirus 2019-epidemiological contact; 15) The researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hangjie Zhang, phD | Contact | +86-13634159682 | hjzhang@cdc.zj.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xihu District Center for Disease Control and Prevention | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37553338 | Derived | Zhang H, Xu N, Xu Y, Qin P, Dai R, Xu B, Wang S, Ding L, Fu J, Zhang S, Hua Q, Liao Y, Yang J, Hu X, Jiang J, Lv H. Safety and immunogenicity of Ad5-nCoV immunization after three-dose priming with inactivated SARS-CoV-2 vaccine in Chinese adults. Nat Commun. 2023 Aug 8;14(1):4757. doi: 10.1038/s41467-023-40489-2. |
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