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

Humanity & Health Medical Group Limited

Overview

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 Type

OBSERVATIONAL

Conditions

Chronic Liver Disease Hepatic Carcinoma

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

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.

Time frame: The 4 weeks after the second dose vaccination

Secondary Outcomes

Safety index-incidence of adverse reactions

Incidence of adverse reactions after each dose vaccination

Time frame: 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.

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