RECOGNISE

Real-world effectiveness of ChAdOx-1s, CoronaVac, BBIBP CorV, mRNA-1273, and BNT162b2 in Jakarta: test-negative design study based in existing health care data sources

Information

This study is a population-based study employing a test-negative case–control design. The study population includes adults aged 18 years and older residing in Jakarta who underwent RT-PCR testing for symptomatic COVID-19 during the Delta and Omicron waves. Participants will be classified as cases if they test positive for SARS-CoV-2 and as controls if they test negative. Vaccination status will be categorized based on the type of vaccine received and the number of doses administered.

Potential confounders will be assessed, including demographic characteristics (age, sex), comorbidities, and other relevant clinical factors. Data will be obtained through linkage of multiple electronic healthcare databases, including laboratory testing records, vaccination registries, and clinical databases. Statistical analyses will be conducted to estimate vaccine effectiveness (VE) against symptomatic COVID-19 and death, as well as to assess waning immunity over time. Following data linkage, all individual identifiers will be encrypted to ensure data confidentiality and privacy.

Astrazeneca

Type of Study

Stakeholders Involved

COVID-19 Vaccine Clinical Trial

Background

ChAdOx-1s, CoronaVac, BBIBP-CorV, mRNA-1273, and BNT162b2 are the five common COVID-19 vaccines that have been used in Jakarta. Randomized control trials have provided robust evidence of 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 healthcare constraints remains unclear.