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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.
This study is a prospective, single-arm, open-label clinical trial. A total of 200 patients with HIV infection were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronavirus vaccination | Experimental | Patients in the experimental need to accept the coronavirus vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronavirus vaccine | Biological | Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection | We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test. | Within 2 months after the first dose of COVID-19 vaccination |
| The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection | The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection. | Within 2 months after the first dose of COVID-19 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection | We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu-Sheng G Wang, MD | Contact | 8610-66933328 | fswang302@163.com | |
| Huihuang G Huang, MD | Contact | 8610-66933471 | hhh302@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shu-juan Li, MD | Beijing 302 Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100039 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Within 13 months after the first dose of COVID-19 vaccination |
| The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection | The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection. | Within 13 months after the first dose of COVID-19 vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |