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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Liver Disease; Hepatic Carcinoma

• Study Type: Observational

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Humanity & Health Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects who received COVID-19 vaccines under real-life practice conditions in the World

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety index-incidence of adverse reactions	Incidence of adverse reactions after each dose vaccination	Day 0-28 after each dose vaccination
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

Collaborators and Investigators

• Sponsor: Humanity & Health Medical Group Limited
• Investigators: Principal Investigator: George Lau, MD, Humanity & Health Medical Group

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Neoplasms; Liver Diseases; Carcinoma, Hepatocellular
• Other Study ID Numbers: APASL_COVID-19 Vaccine_Ab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No