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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04775056
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Humanity & Health Medical Group Limited

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.


Condition or disease
Chronic Liver Disease Hepatic Carcinoma

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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]
    Incidence of adverse reactions after each dose vaccination

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects who received COVID-19 vaccines under real-life practice conditions in the World
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.

Information from the National Library of Medicine

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


Locations
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Hong Kong
Humanity & Health Medical Group
Hong Kong, Hong Kong
Contact: George Lau, MD    (852)28613777    info@hnhmgl.com   
Sponsors and Collaborators
Humanity & Health Medical Group Limited
Investigators
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Principal Investigator: George Lau, MD Humanity & Health Medical Group
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Responsible Party: Humanity & Health Medical Group Limited
ClinicalTrials.gov Identifier: NCT04775056    
Other Study ID Numbers: APASL_COVID-19 Vaccine_Ab
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site