A Study to Evaluate Vaccines Against COVID-19 in the Real World

Chronic Liver Disease Clinical Trial

Official title:

A Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of Vaccines Against COVID-19 in the Real World

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04775056
• Other study ID #: APASL_COVID-19 Vaccine_Ab
• Status: Withdrawn
• Start date: August 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Humanity & Health Medical Group Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Chronic Liver Disease
• Hepatic Carcinoma
• Liver Diseases

Locations

Country	Name	City	State
Hong Kong	Humanity & Health Medical Group	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Humanity & Health Medical Group Limited

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity index-seroconversion rates of neutralizing antibody	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.	The 4 weeks after the second dose vaccination
Secondary	Safety index-incidence of adverse reactions	Incidence of adverse reactions after each dose vaccination	Day 0-28 after each dose vaccination
Secondary	Immunogenicity index-seropositive rates of neutralizing antibody	neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer =1:8 will defined as seropositive.	The 4, 12, 24, and 48 weeks after the second dose vaccination