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COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing
INTRODUCTION: Inactivated, viral vector and mRNA vaccines have been used in the Nepali COVID-19 vaccination programme but there is little evidence on the effectiveness of these vaccines in this setting. The aim of this study is to describe COVID-19 vaccine effectiveness in Nepal and provide informat...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10123857/ https://www.ncbi.nlm.nih.gov/pubmed/37072367 http://dx.doi.org/10.1136/bmjopen-2022-068334 |
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author | Bijukchhe, Sanjeev M O'Reilly, Peter J Theiss-Nyland, Katherine Gurung, Meeru Pokhrel, Bhishma Kelly, Sarah Acharya, Samita Maharjan, Shreekrishna Shrestha, Ashis Pandey, Bimal Lama, Mipsang Shrestha, Ira Voysey, Merryn Eordogh, Agnes Shrestha, Sonu Feng, Elaine Shuo Li, Grace Shah, Ganesh Pollard, Andrew J Shrestha, Shrijana |
author_facet | Bijukchhe, Sanjeev M O'Reilly, Peter J Theiss-Nyland, Katherine Gurung, Meeru Pokhrel, Bhishma Kelly, Sarah Acharya, Samita Maharjan, Shreekrishna Shrestha, Ashis Pandey, Bimal Lama, Mipsang Shrestha, Ira Voysey, Merryn Eordogh, Agnes Shrestha, Sonu Feng, Elaine Shuo Li, Grace Shah, Ganesh Pollard, Andrew J Shrestha, Shrijana |
author_sort | Bijukchhe, Sanjeev M |
collection | PubMed |
description | INTRODUCTION: Inactivated, viral vector and mRNA vaccines have been used in the Nepali COVID-19 vaccination programme but there is little evidence on the effectiveness of these vaccines in this setting. The aim of this study is to describe COVID-19 vaccine effectiveness in Nepal and provide information on infections with SARS-CoV-2 variants. METHODS AND ANALYSIS: This is a hospital-based, prospective test-negative case–control study conducted at Patan Hospital, Kathmandu. All patients >18 years of age presenting to Patan Hospital with COVID-19-like symptoms who have received a COVID-19 antigen/PCR test are eligible for inclusion. The primary outcome is vaccine effectiveness of licensed COVID-19 vaccines against laboratory-confirmed COVID-19 disease. After enrolment, information will be collected on vaccine status, date of vaccination, type of vaccine, demographics and other medical comorbidities. The primary outcome of interest is laboratory-confirmed SARS-CoV-2 infection. Cases (positive for SARS-CoV-2) and controls (negative for SARS-CoV-2) will be enrolled in a 1:4 ratio. Vaccine effectiveness against COVID-19 disease will be analysed by comparing vaccination status with SARS-CoV-2 test results. Positive SARS-CoV-2 samples will be sequenced to identify circulating variants and estimate vaccine effectiveness against common variants. Measuring vaccine effectiveness and identifying SARS-CoV-2 variants in Nepal will help to inform public health efforts. Describing disease severity in relation to specific SARS-CoV-2 variants and vaccine status will also inform future prevention and care efforts. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Oxford Tropical Ethics Committee (OxTREC) (ref: 561-21) and the Patan Academy of Health Sciences Institutional Review Board (ref: drs2111121578). The protocol and supporting study documents were approved for use by the Nepal Health Research Council (NHRC 550-2021). Results will be disseminated in peer-reviewed journals and to the public health authorities in Nepal. |
format | Online Article Text |
id | pubmed-10123857 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-101238572023-04-24 COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing Bijukchhe, Sanjeev M O'Reilly, Peter J Theiss-Nyland, Katherine Gurung, Meeru Pokhrel, Bhishma Kelly, Sarah Acharya, Samita Maharjan, Shreekrishna Shrestha, Ashis Pandey, Bimal Lama, Mipsang Shrestha, Ira Voysey, Merryn Eordogh, Agnes Shrestha, Sonu Feng, Elaine Shuo Li, Grace Shah, Ganesh Pollard, Andrew J Shrestha, Shrijana BMJ Open Public Health INTRODUCTION: Inactivated, viral vector and mRNA vaccines have been used in the Nepali COVID-19 vaccination programme but there is little evidence on the effectiveness of these vaccines in this setting. The aim of this study is to describe COVID-19 vaccine effectiveness in Nepal and provide information on infections with SARS-CoV-2 variants. METHODS AND ANALYSIS: This is a hospital-based, prospective test-negative case–control study conducted at Patan Hospital, Kathmandu. All patients >18 years of age presenting to Patan Hospital with COVID-19-like symptoms who have received a COVID-19 antigen/PCR test are eligible for inclusion. The primary outcome is vaccine effectiveness of licensed COVID-19 vaccines against laboratory-confirmed COVID-19 disease. After enrolment, information will be collected on vaccine status, date of vaccination, type of vaccine, demographics and other medical comorbidities. The primary outcome of interest is laboratory-confirmed SARS-CoV-2 infection. Cases (positive for SARS-CoV-2) and controls (negative for SARS-CoV-2) will be enrolled in a 1:4 ratio. Vaccine effectiveness against COVID-19 disease will be analysed by comparing vaccination status with SARS-CoV-2 test results. Positive SARS-CoV-2 samples will be sequenced to identify circulating variants and estimate vaccine effectiveness against common variants. Measuring vaccine effectiveness and identifying SARS-CoV-2 variants in Nepal will help to inform public health efforts. Describing disease severity in relation to specific SARS-CoV-2 variants and vaccine status will also inform future prevention and care efforts. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Oxford Tropical Ethics Committee (OxTREC) (ref: 561-21) and the Patan Academy of Health Sciences Institutional Review Board (ref: drs2111121578). The protocol and supporting study documents were approved for use by the Nepal Health Research Council (NHRC 550-2021). Results will be disseminated in peer-reviewed journals and to the public health authorities in Nepal. BMJ Publishing Group 2023-04-18 /pmc/articles/PMC10123857/ /pubmed/37072367 http://dx.doi.org/10.1136/bmjopen-2022-068334 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Public Health Bijukchhe, Sanjeev M O'Reilly, Peter J Theiss-Nyland, Katherine Gurung, Meeru Pokhrel, Bhishma Kelly, Sarah Acharya, Samita Maharjan, Shreekrishna Shrestha, Ashis Pandey, Bimal Lama, Mipsang Shrestha, Ira Voysey, Merryn Eordogh, Agnes Shrestha, Sonu Feng, Elaine Shuo Li, Grace Shah, Ganesh Pollard, Andrew J Shrestha, Shrijana COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing |
title | COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing |
title_full | COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing |
title_fullStr | COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing |
title_full_unstemmed | COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing |
title_short | COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing |
title_sort | covid-19 vaccine effectiveness and variants in nepal: study protocol for a test-negative case–control study with sars-cov-2 genetic sequencing |
topic | Public Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10123857/ https://www.ncbi.nlm.nih.gov/pubmed/37072367 http://dx.doi.org/10.1136/bmjopen-2022-068334 |
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