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

NCT04775056 | Withdrawn DMC

• 1 other identifier: APASL_COVID-19 Vaccine_Ab
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety index-incidence of adverse reactions

  Day 0-28 after each dose vaccination

• Immunogenicity index-seropositive rates of neutralizing antibody

  The 4, 12, 24, and 48 weeks after the second dose vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subjects received COVID-19 vaccines;
• Able to comprehend and provide written informed consent in accordance with institutional guidelines.

You may not qualify if:

• Not received any COVID-19 vaccines;
• Not willing to participate and/or give their written informed consent.

Sponsors & Collaborators

• Humanity & Health Medical Group Limited: lead

Study Sites (1)

Humanity & Health Medical Group

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• George Lau, MD

  Humanity & Health Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 1, 2021
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)