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Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial

Introduction: The WHO currently recommends giving pneumococcal conjugate vaccines (PCVs) as three doses – either three doses in infancy with Pentavalent vaccine (3p+0), or two doses in infancy followed by a booster around 12 months (2p+1). However, their high price is a barrier to introduction and s...

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Autores principales: Yoshida, Lay-Myint, Flasche, Stefan, Mulholland, Kim, Nguyen, Hien-Anh, Nguyen, Cattram, Toizumi, Michiko, Dang, Duc-Anh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10539539/
https://www.ncbi.nlm.nih.gov/pubmed/37780234
http://dx.doi.org/10.12688/gatesopenres.14742.1
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author Yoshida, Lay-Myint
Flasche, Stefan
Mulholland, Kim
Nguyen, Hien-Anh
Nguyen, Cattram
Toizumi, Michiko
Dang, Duc-Anh
author_facet Yoshida, Lay-Myint
Flasche, Stefan
Mulholland, Kim
Nguyen, Hien-Anh
Nguyen, Cattram
Toizumi, Michiko
Dang, Duc-Anh
author_sort Yoshida, Lay-Myint
collection PubMed
description Introduction: The WHO currently recommends giving pneumococcal conjugate vaccines (PCVs) as three doses – either three doses in infancy with Pentavalent vaccine (3p+0), or two doses in infancy followed by a booster around 12 months (2p+1). However, their high price is a barrier to introduction and sustainability in low and middle-income countries. We hypothesize that a schedule with a single priming and a booster dose (1p+1) may maintain similar levels of protection for the community by sustaining herd immunity, once circulation of vaccine types has been controlled. Methods and analysis: We will conduct a cluster randomized trial with four intervention arms (1p+1, 0p+1, 2p+1, 3p+0) and three unvaccinated clusters in the 27 communes of Nha Trang, central Vietnam. A PCV catch-up vaccination campaign to all children under three years of age will be performed at the start of the trial. The primary endpoint is non-inferiority of the1p+1 schedule if compared to the WHO standard 2p+1 and 3p+0 schedules in reducing vaccine serotype carriage prevalence in infants. We will also explore impact of 0p+1 schedule. A baseline and annual pneumococcal carriage surveys of 6480 participants per survey covering infants, toddlers and their mothers will be conducted. Ethics and dissemination: Ethical approvals were obtained from the ethical review committees of Institute of Tropical Medicine, Nagasaki University (151203149-2) and the Ministry of Health, Vietnam (1915/QD-BYT). The results, interpretation and conclusions will be presented at national and international conferences, and published in peer-reviewed open access journals. Trial registration number: NCT02961231
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spelling pubmed-105395392023-09-30 Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial Yoshida, Lay-Myint Flasche, Stefan Mulholland, Kim Nguyen, Hien-Anh Nguyen, Cattram Toizumi, Michiko Dang, Duc-Anh Gates Open Res Study Protocol Introduction: The WHO currently recommends giving pneumococcal conjugate vaccines (PCVs) as three doses – either three doses in infancy with Pentavalent vaccine (3p+0), or two doses in infancy followed by a booster around 12 months (2p+1). However, their high price is a barrier to introduction and sustainability in low and middle-income countries. We hypothesize that a schedule with a single priming and a booster dose (1p+1) may maintain similar levels of protection for the community by sustaining herd immunity, once circulation of vaccine types has been controlled. Methods and analysis: We will conduct a cluster randomized trial with four intervention arms (1p+1, 0p+1, 2p+1, 3p+0) and three unvaccinated clusters in the 27 communes of Nha Trang, central Vietnam. A PCV catch-up vaccination campaign to all children under three years of age will be performed at the start of the trial. The primary endpoint is non-inferiority of the1p+1 schedule if compared to the WHO standard 2p+1 and 3p+0 schedules in reducing vaccine serotype carriage prevalence in infants. We will also explore impact of 0p+1 schedule. A baseline and annual pneumococcal carriage surveys of 6480 participants per survey covering infants, toddlers and their mothers will be conducted. Ethics and dissemination: Ethical approvals were obtained from the ethical review committees of Institute of Tropical Medicine, Nagasaki University (151203149-2) and the Ministry of Health, Vietnam (1915/QD-BYT). The results, interpretation and conclusions will be presented at national and international conferences, and published in peer-reviewed open access journals. Trial registration number: NCT02961231 F1000 Research Limited 2023-07-20 /pmc/articles/PMC10539539/ /pubmed/37780234 http://dx.doi.org/10.12688/gatesopenres.14742.1 Text en Copyright: © 2023 Yoshida LM et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Yoshida, Lay-Myint
Flasche, Stefan
Mulholland, Kim
Nguyen, Hien-Anh
Nguyen, Cattram
Toizumi, Michiko
Dang, Duc-Anh
Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial
title Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial
title_full Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial
title_fullStr Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial
title_full_unstemmed Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial
title_short Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial
title_sort evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in vietnam: protocol for a cluster randomized non-inferiority trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10539539/
https://www.ncbi.nlm.nih.gov/pubmed/37780234
http://dx.doi.org/10.12688/gatesopenres.14742.1
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