A Study to Evaluate Vaccines Against COVID-19 in the Real World
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|ClinicalTrials.gov Identifier: NCT04775056|
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : March 2, 2021
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.
|Condition or disease|
|Chronic Liver Disease Hepatic Carcinoma|
|Study Type :||Observational|
|Estimated Enrollment :||30000 participants|
|Official Title:||A Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of Vaccines Against COVID-19 in the Real World|
|Estimated Study Start Date :||March 15, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 31, 2022|
- Immunogenicity index-seroconversion rates of neutralizing antibody [ Time Frame: 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.
- Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]Incidence of adverse reactions after each dose vaccination
- Immunogenicity index-seropositive rates of neutralizing antibody [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775056
|Humanity & Health Medical Group|
|Hong Kong, Hong Kong|
|Contact: George Lau, MD (852)28613777 email@example.com|
|Principal Investigator:||George Lau, MD||Humanity & Health Medical Group|