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Constructing Mutants in Serotype 1 Streptococcus pneumoniae strain 519/43
Published on: September 11, 2020
Multicentre case-control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia
Nurul Hanis Ramzi1, Andrew Tan Chun Hoong2, Nur Alia Johari2
1Institute for Research, Development and Innovation, IMU University (formerly known as International Medical University), Kuala Lumpur, 57000, Malaysia. nurulhanis@imu.edu.my.
Insights
This study establishes a surveillance program in Malaysia to understand pneumococcal pneumonia in young children. Data will inform public health strategies and vaccine policy decisions regarding pneumococcal conjugate vaccine (PCV10) effectiveness.
Area of Science:
- Pediatric Infectious Diseases
- Public Health Surveillance
- Vaccinology
Background:
- Streptococcus pneumoniae (SPN) is a leading cause of childhood pneumonia, preventable by vaccination.
- Malaysia's National Immunisation Programme (NIP) includes the 10-valent pneumococcal conjugate vaccine (PCV10) for infants.
- Limited understanding of pneumonia epidemiology hinders targeted public health interventions.
Purpose of the Study:
- To establish a multicentre surveillance study (MY-Pneumo) in Peninsular Malaysia.
- To determine the burden of pneumococcal pneumonia in children under 5 years old.
- To generate data on SPN epidemiology, including serotype variations and carriage rates, during PCV implementation.
Main Methods:
- A prospective case-control study enrolling at least 500 cases and 500 age-matched controls.
- Cases are hospitalized children <5 years with radiologically confirmed pneumonia.
- Samples (nasopharyngeal swabs, urine, blood, CSF, pleural fluid) analyzed by PCR and urine antigen tests.
Main Results:
- The study will generate crucial surveillance data on SPN carriage rates and serotype distribution.
- Regional trends and patterns of pneumococcal serotypes will be identified.
- Baseline information will be established for evaluating PCV10 impact.
Conclusions:
- The MY-Pneumo study will provide essential data to guide public health strategies in Malaysia.
- Findings will inform policymakers on the potential need to upgrade from PCV10 to higher-valency vaccines.
- This research addresses a critical knowledge gap in pediatric pneumococcal disease epidemiology.
Background:
S. pneumoniae (SPN) is the most common cause of pneumonia. The disease can be effectively prevented through immunisation. Since December 2020, the Malaysian Government has included the 10-valent pneumococcal conjugate vaccine (PCV10) for all infants born on or after 1 January 2020 as part of the National Immunisation Programme (NIP). However, the epidemiology of pneumonia remains poorly understood. To fill the knowledge gap, we established a multicentre surveillance study to understand the burden of pneumococcal pneumonia among young children in Peninsular Malaysia.
Methods:
MY-Pneumo is a multicentre prospective case-control study conducted in three sentinel sites located in three different states of Peninsular Malaysia - Kuala Lumpur, Pahang, and Kelantan. A cohort of at least 500 incident cases and 500 controls is enrolled beginning in October 2021 and matched for age. Cases are hospitalised children < 5 years with radiologically confirmed pneumonia, and the controls are children without any features suggestive of pneumonia. Clinical samples, including nasopharyngeal swabs (NPS) and urine, are collected according to the study protocol. Biological fluids such as blood, cerebrospinal fluid (CSF) and pleural fluid are obtained from invasive pneumonia disease (IPD) patients, if available. All children are tested for SPN using polymerase chain reaction (PCR) and pneumococcal urine antigen test (PUAT) using BinaxNow.
Discussion:
Surveillance data, including carriage rate, serotype variations and the phylogeny data structure of SPN among young children in Malaysia during PCV implementation, will be generated from this study. Trends and patterns of pneumococcal serotypes by different regions are important for targeted public health strategies. Our data will provide baseline information for estimating the impact of PCV10 implementation and will influence policymakers' decisions regarding the upgrade from PCV10 to a higher-valency conjugate vaccine in Malaysia.
Trial Registration:
This project was registered at ClinicalTrials.gov (NCT04923035) on 2021, June 11. The study protocol was approved by the International Medical University Joint-Committee on Research & Ethics (4.15/JCM-216/2021) and the Institutional Review Board at sentinel sites (USM/JEPeM/21020190, IREC 2021-114, MREC ID No: 2021128-9769) and University of Southampton's Ethics and Research Governance (ERGo II 64844).
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