Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal study

Introduction Neutralising antibodies (NAbs) have been shown to be correlative of immune protection against SARS-CoV-2. We report the protocol for a national longitudinal study to assess and compare the level of NAbs generated in response to COVID-19 vaccines in Brunei Darussalam in adults 2–6 weeks...

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Main Authors: Yan Wang, Feng Zhu, Yuan Wei, Lin Naing, Justin Wong, Hazim Ghani, Liyana Ahmad, Hanisah Sharif, Saifuddien Bagol, Mohammad Fathi Alikhan, Surita Taib, Chee Wah Tan, Xin Mei Ong, Chin Yee Shim, Si Yee Chan, Fazean Idris, Lin-Fa Wang, Anne Catherine Cunningham
Format: Article
Language:English
Published: BMJ Publishing Group 2022-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/12/e067020.full
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author Yan Wang
Feng Zhu
Yuan Wei
Lin Naing
Justin Wong
Hazim Ghani
Liyana Ahmad
Hanisah Sharif
Saifuddien Bagol
Mohammad Fathi Alikhan
Surita Taib
Chee Wah Tan
Xin Mei Ong
Chin Yee Shim
Si Yee Chan
Fazean Idris
Lin-Fa Wang
Anne Catherine Cunningham
author_facet Yan Wang
Feng Zhu
Yuan Wei
Lin Naing
Justin Wong
Hazim Ghani
Liyana Ahmad
Hanisah Sharif
Saifuddien Bagol
Mohammad Fathi Alikhan
Surita Taib
Chee Wah Tan
Xin Mei Ong
Chin Yee Shim
Si Yee Chan
Fazean Idris
Lin-Fa Wang
Anne Catherine Cunningham
author_sort Yan Wang
collection DOAJ
description Introduction Neutralising antibodies (NAbs) have been shown to be correlative of immune protection against SARS-CoV-2. We report the protocol for a national longitudinal study to assess and compare the level of NAbs generated in response to COVID-19 vaccines in Brunei Darussalam in adults 2–6 weeks post primary series (BBIBP-CorV, AZD1222, or mRNA-1273 vaccines) and their subsequent follow-up after administration of a third (booster-1) dose (BBIBP-CorV, mRNA-1273, or BNT162b2).Methods and analysis Participant data will be extracted and processed from the national electronic health record system (Bru-HIMS) and the national mobile health application (BruHealth) into a research data platform. Eligible adults who have received their primary or booster vaccine will be invited using a stratified random sampling strategy based on age, gender and vaccine type (baseline target population, n=3000; 2–6 weeks post last dose). Blood serum will be isolated, and NAb levels assessed using the cPass surrogate virus neutralisation test. Baseline participants will then be screened for eligibility for subsequent longitudinal analysis. Those who have received a third dose will be followed up at 1, 3, 6, 9 and up to 12 months. NAb levels will be evaluated across the participant population according to vaccine platform/booster type, time since the last dose and correlated with demographic data. The study period is from December 2021 to January 2023 and aims to evaluate how NAb levels wane following a third vaccine dose across different vaccine platforms and determine the impact and rate of breakthrough infections.Ethics and dissemination This study has been approved by the Medical and Ethical Research Committee of Ministry of Health, Brunei Darussalam. Individual NAb test results will be shared with each participant by text message. The findings from this study will help policy-makers in Brunei develop future vaccination strategies and establish regulations across multiple agencies.
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spelling doaj-art-d170f2132e344b2fb3f3eaca79281a9b2025-08-20T02:57:20ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-067020Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal studyYan Wang0Feng Zhu1Yuan Wei2Lin Naing3Justin Wong4Hazim Ghani5Liyana Ahmad6Hanisah Sharif7Saifuddien Bagol8Mohammad Fathi Alikhan9Surita Taib10Chee Wah Tan11Xin Mei Ong12Chin Yee Shim13Si Yee Chan14Fazean Idris15Lin-Fa Wang16Anne Catherine Cunningham17Department of Medical Science and Strategy Oncology, Innovent Biologics, Inc, Suzhou, ChinaMedicine (Neurology), University of British Columbia, Vancouver, British Columbia, CanadaLonggang District People’s Hospital of Shenzhen & The Third Affiliated Hospital (Provisional) of The Chinese University of Hong Kong, Shenzhen, Guangdong, ChinaPAPRSB Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamPAPRSB Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamPAPRSB Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamPAPRSB Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamPAPRSB Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamDepartment of Laboratory Services, Ministry of Health Brunei Darussalam, Bandar Seri Begawan, Brunei-Muara, Brunei DarussalamEVYD Research Pte Ltd, A Subsidiary of EVYD Technology Limited, SingaporeDepartment of Laboratory Services, Ministry of Health Brunei Darussalam, Bandar Seri Begawan, Brunei-Muara, Brunei DarussalamProgramme in Emerging Infectious Diseases, Duke-NUS Medical School, SingaporeProgramme in Emerging Infectious Diseases, Duke-NUS Medical School, SingaporeEVYD Research Pte Ltd, A Subsidiary of EVYD Technology Limited, SingaporeEVYD Research Pte Ltd, A Subsidiary of EVYD Technology Limited, SingaporePAPRSB Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamProgramme in Emerging Infectious Diseases, Duke-NUS Medical School, SingaporePAPRSB Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamIntroduction Neutralising antibodies (NAbs) have been shown to be correlative of immune protection against SARS-CoV-2. We report the protocol for a national longitudinal study to assess and compare the level of NAbs generated in response to COVID-19 vaccines in Brunei Darussalam in adults 2–6 weeks post primary series (BBIBP-CorV, AZD1222, or mRNA-1273 vaccines) and their subsequent follow-up after administration of a third (booster-1) dose (BBIBP-CorV, mRNA-1273, or BNT162b2).Methods and analysis Participant data will be extracted and processed from the national electronic health record system (Bru-HIMS) and the national mobile health application (BruHealth) into a research data platform. Eligible adults who have received their primary or booster vaccine will be invited using a stratified random sampling strategy based on age, gender and vaccine type (baseline target population, n=3000; 2–6 weeks post last dose). Blood serum will be isolated, and NAb levels assessed using the cPass surrogate virus neutralisation test. Baseline participants will then be screened for eligibility for subsequent longitudinal analysis. Those who have received a third dose will be followed up at 1, 3, 6, 9 and up to 12 months. NAb levels will be evaluated across the participant population according to vaccine platform/booster type, time since the last dose and correlated with demographic data. The study period is from December 2021 to January 2023 and aims to evaluate how NAb levels wane following a third vaccine dose across different vaccine platforms and determine the impact and rate of breakthrough infections.Ethics and dissemination This study has been approved by the Medical and Ethical Research Committee of Ministry of Health, Brunei Darussalam. Individual NAb test results will be shared with each participant by text message. The findings from this study will help policy-makers in Brunei develop future vaccination strategies and establish regulations across multiple agencies.https://bmjopen.bmj.com/content/12/12/e067020.full
spellingShingle Yan Wang
Feng Zhu
Yuan Wei
Lin Naing
Justin Wong
Hazim Ghani
Liyana Ahmad
Hanisah Sharif
Saifuddien Bagol
Mohammad Fathi Alikhan
Surita Taib
Chee Wah Tan
Xin Mei Ong
Chin Yee Shim
Si Yee Chan
Fazean Idris
Lin-Fa Wang
Anne Catherine Cunningham
Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal study
BMJ Open
title Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal study
title_full Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal study
title_fullStr Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal study
title_full_unstemmed Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal study
title_short Immunogenicity of COVID-19 vaccines and levels of SARS-CoV-2 neutralising antibody in the Bruneian population: Protocol for a national longitudinal study
title_sort immunogenicity of covid 19 vaccines and levels of sars cov 2 neutralising antibody in the bruneian population protocol for a national longitudinal study
url https://bmjopen.bmj.com/content/12/12/e067020.full
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