@Article{info:doi/10.2196/56519,
author="Burhan, Erlina
and Azzumar, Farchan
and Sinuraya, Fira Alyssa Gabriella
and Rakasiwi, Muhammad Ilham Dhiya
and Akbar, Ihya
and Mubarak, Farhan
and Rengganis, Anggit Tresna
and Rachmadi, Rizky Abi
and Afidjati, Hera",
title="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",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="10",
volume="14",
pages="e56519",
keywords="COVID-19; protocol; vaccine; vaccine effectiveness; Delta; Omicron",
abstract="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 ",
issn="1929-0748",
doi="10.2196/56519",
url="https://www.researchprotocols.org/2025/1/e56519",
url="https://doi.org/10.2196/56519",
url="http://www.ncbi.nlm.nih.gov/pubmed/39902869"
}