Novel coronavirus pneumonia (COVID-19)
Conditions
Interventions
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. People aged>= 18 years; 2. Before entering this study,the axillary temperature is under 37.3 degree after medical history and physical examination; 3. Patients who meet the diagnostic criteria for HIV-infected and AIDS patients; 4. Female subjects of childbearing age declared that they were not pregnant, had no family planning within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before enrollment. The above statements are signed for confirmation; For those who are unknown whether they are pregnant or not, it is necessary to confirm that they are not pregnant by negative urine pregnancy test; 5. The subjects who are able and willing to complete the whole research plan during the whole follow-up period; 6. The subjects have the ability to understand the research procedure, and voluntarily sign the informed consent after informed consent, and can comply with the requirements of the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1. The subjects were previously confirmed cases of novel coronavirus or asymptomatic infection; 2. The subjects had a history of COVID-19 vaccination; 3. People who are known to be allergic to any ingredients (including excipients) contained in this product; 4. Previous severe allergic reactions to vaccination (such as acute allergic reactions, angioneurotic edema, dyspnea, etc.); 5. People who has uncontrolled epilepsy and other progressive neurological diseases, and has a history of Guillain-Barré syndrome; 6. Pregnant and lactating women; 7. The recipient is suffering from an acute disease; or a patient with thrombocytopenia has a platelet count of less than 20x10^9/L within three days before vaccination, that is, a patient at high risk of spontaneous bleeding; 8. During the acute phase of HIV and opportunistic infections; 9. People with opportunistic infections who have not received antiviral treatment; 10. HIV-infected persons who have not received antiviral treatment and have a CD4 count of less than 50/ul; 11. HIV-infected persons who are undergoing treatment with severe drug interactions and overlapping toxicities (kidney damage, liver damage, blood system problems, etc.); 12. Patients with malignant tumors are undergoing chemotherapy and radiotherapy before and after surgery; 13. Other patients who have been judged by the researchers that their physical condition is not suitable for inclusion in the scope of active monitoring.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Novel coronavirus antibody 4 times growth rate and antibody level;incidence of adverse reactions/events;incidence of adverse reactions/events;incidence of Serious Adverse Events(SAE); | — |
Countries
China
Contacts
Public ContactZhang Xianfeng
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed