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

NCT ID: NCT04775056

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-12-31

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.

Conditions

Chronic Liver Disease; Hepatic Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Humanity & Health Medical Group Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Humanity & Health Medical Group

Locations

Humanity & Health Medical Group

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

APASL_COVID-19 Vaccine_Ab

Identifier Type: -

Identifier Source: org_study_id