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| Name | Class |
|---|---|
| Zhejiang Provincial Center for Disease Control and Prevention | OTHER_GOV |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .
The subjects aged ≥18 years with HIV infected who have completed the schedule of two doses for 3 months recruited to receive a third dose of inactivated COVID-19 vaccine.
Blood samples will be collected 3 times: before the third dose of vaccinatioin,28 days and 6 months after the third dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Subjects receive a third dose of inactivated COVID-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated COVID-19 vaccine | Biological | receive a third dose of inactivated COVID-19 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | The rate of seroconversion against coronavirus | 28 days after the 3th dose (Day 28) |
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus before the 3th dose | Before the 3th dose (Day 0) |
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 28 days after the 3th dose (Day 28) |
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 6 months after the 3th dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events rate | Analyse the incidence of adverse events following vaccination, both solicited and unsolicited | 0-21days following vaccinations |
| Serious adverse event rate | Report and analyse serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanqing He | Contact | (0571)87115111 | hanqinghe@cdc.zj.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hanqing He | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang provincial center for disease control and prevention | Hangzhou | Zhejiang | 310051 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Subjects aged ≥18 with infected with HIV who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.
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| 0-6 months |
| T cell count | T cell count (CD4+T,CD8+T,etc.) | before the 3th dose (Day 0) |
| T cell count | T cell count (CD4+T,CD8+T,etc.) | 28 days after the 3th dose (Day 28) |
| HIV viral load | HIV viral load | before the 3th dose (Day 0) |
| HIV viral load | HIV viral load | 28 days after the 3th dose (Day 28) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |