Chronic Liver Disease, Hepatic Carcinoma
Conditions
Brief summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have afflicted tens of millions of people in a worldwide pandemic. Considering its high mortality and rapid spread, an effective vaccine is urgently needed to control this pandemic. Recently, mass vaccination campaigns using newly approved vaccines, ranging from conventional viral and protein-based vaccines to those that are more cutting edge, including DNA- and mRNA-based vaccines are beginning in many parts of the world. Randomized clinical trials of different vaccines reported efficacies for preventing COVID-19 in the range of 50% to 95%. Although these randomized clinical trials are considered the gold standard for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout. The aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of different vaccines against COVID-19 under real-world practice conditions.
Interventions
None listed
Sponsors
Humanity & Health Medical Group Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects received COVID-19 vaccines; * Able to comprehend and provide written informed consent in accordance with institutional guidelines.
Exclusion criteria
* Not received any COVID-19 vaccines; * Not willing to participate and/or give their written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity index-seroconversion rates of neutralizing antibody | The 4 weeks after the second dose vaccination | Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety index-incidence of adverse reactions | Day 0-28 after each dose vaccination | Incidence of adverse reactions after each dose vaccination |
| Immunogenicity index-seropositive rates of neutralizing antibody | The 4, 12, 24, and 48 weeks after the second dose vaccination | neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive. |
Countries
Hong Kong
Outcome results
None listed