新冠疫苗（ChAdOx-1s、科兴疫苗、BBIBP-CorV、mRNA-1273和BNT162b2）在雅加达的真实世界有效性：医疗保健数据检测阴性设计方案
Real-World Effectiveness of COVID-19 Vaccines (ChAdOx-1s, CoronaVac, BBIBP-CorV, mRNA-1273, and BNT162b2) in Jakarta: Protocol for Test-Negative Design of Health Care Data.
作者信息
Burhan Erlina, Azzumar Farchan, Sinuraya Fira Alyssa Gabriella, Rakasiwi Muhammad Ilham Dhiya, Akbar Ihya, Mubarak Farhan, Rengganis Anggit Tresna, Rachmadi Rizky Abi, Afidjati Hera
机构信息
Department of Pulmonology and Respiratory Medicine, Faculty of Medicine Universitas Indonesia-Persahabatan Hospital, Jakarta, Indonesia.
Indonesian Society of Respirology, Jakarta, Indonesia.
出版信息
JMIR Res Protoc. 2025 Apr 10;14:e56519. doi: 10.2196/56519.
BACKGROUND
ChAdOx-1s, CoronaVac, BBIBP-CorV, mRNA-1273, and BNT162b2 are the five common COVID-19 vaccines used in Jakarta. Randomized controlled trials have provided robust evidence of the safety and efficacy profile of these vaccines, but their real-world vaccine effectiveness against symptomatic COVID-19 and deaths in communities with social inequalities and health care constraints remains unclear.
OBJECTIVE
This study aims to evaluate the real-world effectiveness of these COVID-19 vaccines during the waves associated with the Delta and Omicron variants by analyzing existing electronic health care sources.
METHODS
A population-based study with a test-negative case-control design will be used to evaluate COVID-19 vaccine effectiveness in Jakarta, focusing on the Delta and Omicron waves. It includes adults 18 years and older who underwent reverse transcription polymerase chain reaction testing for symptomatic COVID-19, classifying them as cases or controls based on their test results. The analysis will consider multiple COVID-19 vaccines introduced during these periods, with participants categorized by vaccination status. Several potential confounders will be assessed, including demographic factors and comorbidities. Data will be linked from various health datasets, and statistical analyses will be performed to determine vaccine effectiveness and potential waning immunity over time. After data linkage, patients' identities will be encrypted.
RESULTS
The research, funded from 2022 to 2024, involved proposal preparation and ethical review in 2023 and enrollment from early 2024 to July 2024, resulting in about 4 million linked data points. Data analysis is ongoing, with initial results expected for publication in early 2025.
CONCLUSIONS
This study will be the first to evaluate the effectiveness of different types of COVID-19 vaccines (inactivated, viral-vector, and mRNA) used in Jakarta during the pandemic, providing valuable scientific evidence to inform future vaccination strategies in the country.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56519.
背景
ChAdOx-1s、科兴疫苗、BBIBP-CorV、mRNA-1273和BNT162b2是雅加达使用的五种常见新冠疫苗。随机对照试验已经为这些疫苗的安全性和有效性提供了有力证据，但在存在社会不平等和医疗保健限制的社区中，它们针对有症状新冠病毒感染和死亡的实际疫苗效果仍不明确。
目的
本研究旨在通过分析现有的电子医疗保健数据源，评估这些新冠疫苗在与德尔塔和奥密克戎变异株相关的疫情浪潮期间的实际效果。
方法
一项采用检测阴性病例对照设计的基于人群的研究将用于评估雅加达的新冠疫苗效果，重点关注德尔塔和奥密克戎疫情浪潮。研究对象包括18岁及以上因有症状的新冠病毒感染接受逆转录聚合酶链反应检测的成年人，并根据检测结果将他们分类为病例或对照。分析将考虑这些时期引入的多种新冠疫苗，参与者按疫苗接种状态分类。将评估几个潜在的混杂因素，包括人口统计学因素和合并症。数据将从各种健康数据集进行关联，并进行统计分析以确定疫苗效果和随时间推移可能出现的免疫力下降情况。在数据关联后，患者身份将被加密。
结果
该研究由2022年至2024年资助，2023年进行了提案准备和伦理审查，2024年初至2024年7月进行了入组，产生了约400万个关联数据点。数据分析正在进行中，初步结果预计于2025年初发表。
结论
本研究将首次评估疫情期间雅加达使用的不同类型新冠疫苗（灭活疫苗、病毒载体疫苗和mRNA疫苗）的效果，为该国未来的疫苗接种策略提供有价值的科学证据。
国际注册报告识别码（IRRID）：DERR1-10.2196/56519。
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