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 [version 1; peer review: 2 approved, 1 approved with reservations]
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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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2023-07-01
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| Series: | Gates Open Research |
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| Online Access: | https://gatesopenresearch.org/articles/7-110/v1 |
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| author | Lay-Myint Yoshida Kim Mulholland Stefan Flasche Cattram Nguyen Hien-Anh Nguyen Duc-Anh Dang Michiko Toizumi |
| author_facet | Lay-Myint Yoshida Kim Mulholland Stefan Flasche Cattram Nguyen Hien-Anh Nguyen Duc-Anh Dang Michiko Toizumi |
| author_sort | Lay-Myint Yoshida |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-03-11T21:15:43Z |
| format | Article |
| id | doaj.art-30b90f3aec9a417781601ce9ca0ebf91 |
| institution | Directory Open Access Journal |
| issn | 2572-4754 |
| language | English |
| last_indexed | 2024-03-11T21:15:43Z |
| publishDate | 2023-07-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | Gates Open Research |
| spelling | doaj.art-30b90f3aec9a417781601ce9ca0ebf912023-09-29T00:00:00ZengF1000 Research LtdGates Open Research2572-47542023-07-01716068Evaluation 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 [version 1; peer review: 2 approved, 1 approved with reservations]Lay-Myint Yoshida0https://orcid.org/0000-0002-7567-3248Kim Mulholland1Stefan Flasche2Cattram Nguyen3Hien-Anh Nguyen4Duc-Anh Dang5Michiko Toizumi6Department of Pediatric Infectious Diseases, Institute of Tropical Medicine, Nagasaki University, Nagasaki, JapanDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UKCentre For Mathematical Modelling of Infectious Diseases, London School of Hygiene and Tropical Medicine, London, UKDepartment of Infection and Immunity, Murdoch Children's Research Institute, Parkville, Victoria, AustraliaDepartment of Bacteriology, National Institute of Hygiene and Epidemiology, Hanoi, VietnamDepartment of Bacteriology, National Institute of Hygiene and Epidemiology, Hanoi, VietnamDepartment of Pediatric Infectious Diseases, Institute of Tropical Medicine, Nagasaki University, Nagasaki, JapanIntroduction: 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: NCT02961231https://gatesopenresearch.org/articles/7-110/v1Pneumococcal conjugate vaccine (PCV) Reduced dosing schedule Vietnam vaccine trialeng |
| spellingShingle | Lay-Myint Yoshida Kim Mulholland Stefan Flasche Cattram Nguyen Hien-Anh Nguyen Duc-Anh Dang Michiko Toizumi 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 [version 1; peer review: 2 approved, 1 approved with reservations] Gates Open Research Pneumococcal conjugate vaccine (PCV) Reduced dosing schedule Vietnam vaccine trial eng |
| 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 [version 1; peer review: 2 approved, 1 approved with reservations] |
| 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 [version 1; peer review: 2 approved, 1 approved with reservations] |
| 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 [version 1; peer review: 2 approved, 1 approved with reservations] |
| 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 [version 1; peer review: 2 approved, 1 approved with reservations] |
| 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 [version 1; peer review: 2 approved, 1 approved with reservations] |
| title_sort | evaluation of the effect of reduced dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naive population in vietnam protocol for a cluster randomized non inferiority trial version 1 peer review 2 approved 1 approved with reservations |
| topic | Pneumococcal conjugate vaccine (PCV) Reduced dosing schedule Vietnam vaccine trial eng |
| url | https://gatesopenresearch.org/articles/7-110/v1 |
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