Multiyear prospective cohort study to evaluate the risk potential of MERS-CoV infection among Malaysian Hajj pilgrims (MERCURIAL): a study protocol

Abstract

IntroductionMiddle East respiratory syndrome (MERS) is a viral respiratory infection caused by the MERS-CoV. MERS was first reported in the Kingdom of Saudi Arabia in 2012. Every year, the Hajj pilgrimage to Mecca attracts more than two million pilgrims from 184 countries, making it one of the largest annual religious mass gatherings (MGs) worldwide. MGs in confined areas with a high number of pilgrims’ movements worldwide continues to elicit significant global public health concerns. MERCURIAL was designed by adopting a seroconversion surveillance approach to provide multiyear evidence of MG-associated MERS-CoV seroconversion among the Malaysian Hajj pilgrims.Methods and analysisMERCURIAL is an ongoing multiyear prospective cohort study. Every year, for the next 5 years, a cohort of 1000 Hajj pilgrims was enrolled beginning in the 2016 Hajj pilgrimage season. Pre-Hajj and post-Hajj serum samples were obtained and serologically analysed for evidence of MERS-CoV seroconversion. Sociodemographic data, underlying medical conditions, symptoms experienced during Hajj pilgrimage, and exposure to camel and untreated camel products were recorded using structured pre-Hajj and post-Hajj questionnaires. The possible risk factors associated with the seroconversion data were analysed using univariate and multivariate logistic regression. The primary outcome of this study is to better enhance our understanding of the potential threat of MERS-CoV spreading through MG beyond the Middle East.Ethics and disseminationThis study has obtained ethical approval from the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia. Results from the study will be submitted for publication in peer-reviewed journals and presented in conferences and scientific meetings.Trial registration numberNMRR-15-1640-25391.

MERS-CoV seroconversion amongst Malaysian Hajj pilgrims returning from the Middle East, 2016–2018: results from the MERCURIAL multiyear prospective cohort study

“…A multiyear prospective cohort study was conducted amongst Malaysian pilgrims who performed Hajj between 2016 and 2018, were aged 18 years and above, and were residing around the Greater Kuala Lumpur metropolitan area (including Putrajaya and Selangor). The study protocol was based on MERCURIAL, a longitudinal seroconversion surveillance study by Johari et al [ 25 ]. This study received IRB ethical approval from the Medical Research and Ethics Committee (MREC), Ministry of Health, Malaysia (NMRR-15-1640-25391).…”

“…Pre-Hajj enrolment and serum sampling were conducted during routine health screenings of the prospective Malaysian Hajj pilgrims at six healthcare institutions around the Greater Kuala Lumpur metropolitan area [ 25 ]. Participants in the study were provided with an overview of the study's scope, objectives, and procedures.…”

COVID-19 and other respiratory tract infections at mass gathering religious and sporting events

“…The primary outcome of this study is to determine the risk of exposure to MERS- CoV by examining the rate of seroconversion and to ascertain the percentage of exposed individuals that go unreported due to a lack of symptoms or mild clinical presentations. It also aims to delineate risk factors such as age, gender, exposure to camels or untreated camel products associated with seroconversion to MERS-CoV within the described Hajj pilgrimage cohort [8 ▪▪ ].…”