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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
| Health and Medical Research Fund | OTHER_GOV |
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(a) Objectives
The health conditions of adults (N=300) who recovered from varying severity of COVID-19 will be assessed and their blood are collected at 6, 12, 24 and 36 months after discharge. The assessment package includes: lung function tests, 6-min walk distance, chest radiographs/CT, and SF36 General Health questionnaire. Blood samples from community cohorts will be collected from before and up to 36 months after receiving one of the three COVID-19 vaccines (N=200 per vaccine type). The kinetics of SARS-CoV-2 specific humoral and cellular immunities from both convalescent and vaccinated cohorts are determined by neutralization assay and by measuring specific T cell responses upon stimulation of SARS-CoV-2 specific peptide library respectively. The antiviral level of the human plasma with various neutralization titer collected from different vaccinated cohorts will be tested in mouse model and ADCC assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID survivors | |||
| Vaccination with CoronaVac vaccine |
| ||
| Vaccination with BionTech vaccine |
| ||
| third dose vaccination with CoronaVac vaccine | We propose to invite 80 participants who have already completed the 2 doses vaccination of CoronaVac with low level of neutralizing antibody at 1-month post-vaccination to join this additional study. They will be randomized to receive a booster dose of Coronavac or BionTech in equal numbers (n=40 each group). |
| |
| third dose vaccination with BionTech vaccine | We propose to invite 80 participants who have already completed the 2 doses vaccination of CoronaVac with low level of neutralizing antibody at 1-month post-vaccination to join this additional study. They will be randomized to receive a booster dose of Coronavac or BionTech in equal numbers (n=40 each group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| third dose vaccination with CoronaVac vaccine | Biological | Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of CoronaVac vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| spirometry | FEV1 and FVC | 3 years |
| Lung volume | Litres | 3 years |
| 6 minute walk distance | meters | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life by SF36 questionnaire | scores in all domains | 3 years |
| serology and T cell response | titers | 3 years |
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Inclusion Criteria: Patients who have been discharged from hospital following treatment for COVID-19 -
Exclusion Criteria: Unwilling to be follow up
-
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Adult patients (about 80) who have been discharged following treatment for COVID-19 will be followed up at the Prince of Wales Hospital at 4 weeks after discharge, 6, 12, 18 and 24 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanna Ng, MBChB | Contact | 85235053128 | drsssng@gmail.com | |
| Karen Yiu, BSc | Contact | 85235053532 | ysyiu@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| David S Hui, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37964259 | Derived | Chan KKP, Ng SSS, Lui GCY, Leung HS, Wong KT, Chu WCW, Chan TO, Yiu KYS, Tso EYK, To KW, Ngai JCL, Yip TWH, Lo RLP, Ng JKC, Ko FWS, Hui DSC. Comparison of the 12-month impact of COVID-19 and SARS on physiological capacity and health-related quality of life. BMC Pulm Med. 2023 Nov 14;23(1):441. doi: 10.1186/s12890-023-02750-8. |
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data pending
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Blood will be taken for serology testing and T cell response after discharge, 6, 12, 18 and 24 months.
| third dose vaccination with BionTech vaccine | Biological | Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine |
|
| Vaccination with Coronavac vaccine | Biological | Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart |
|
| Vaccination with BionTech Vaccine | Biological | Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart |
|
| 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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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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