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Determining the pneumococcal conjugate vaccine coverage required for indirect protection against vaccine-type pneumococcal carriage in low and middle-income countries: a protocol for a prospective observational study
  1. Jocelyn Chan1,2,
  2. Cattram D Nguyen1,2,
  3. Jana Y R Lai1,
  4. Eileen M Dunne1,2,
  5. Ross Andrews3,4,
  6. Christopher C Blyth5,6,
  7. Siddhartha Datta7,
  8. Kim Fox8,
  9. Rebecca Ford9,
  10. Jason Hinds10,11,
  11. Sophie La Vincente1,
  12. Deborah Lehmann12,
  13. Ruth Lim1,
  14. Tuya Mungun13,
  15. Paul N Newton14,15,
  16. Rattanaphone Phetsouvanh14,15,
  17. Willam S Pomat9,12,
  18. Anonh Xeuatvongsa16,
  19. Claire von Mollendorf1,2,
  20. David A B Dance15,
  21. Catherine Satzke1,17,
  22. Kim Muholland1,18,
  23. Fiona M Russell1,19
  24. for the PneuCAPTIVE Protocol Group
  1. 1 Pneumococcal Research Group, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
  2. 2 Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia
  3. 3 Global & Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Australia
  4. 4 National Centre for Epidemiology & Population Health, Australian National University, Canberra, Australia
  5. 5 School of Medicine, University of Western Australia, Perth, Australia
  6. 6 Department of Infectious Diseases, Princess Margaret Hospital, Perth, Australia
  7. 7 World Health Organization, Vientiane, Lao People’s Democratic Republic
  8. 8 Regional Office for the Western Pacific, World Health Organization, Manila, Philippines
  9. 9 Infection and Immunity Unit, Papua New Guinea Institute of Medical Research, Goroka, Eastern Highlands, Papua New Guinea
  10. 10 Institute for Infection and Immunity, St George’s, University of London, London, UK
  11. 11 BUGS Bioscience, London Bioscience Innovation Centre, London, UK
  12. 12 Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Australia
  13. 13 National Center of Communicable Diseases (NCCD), Ministry of Health, Ulaanbaatar, Mongolia
  14. 14 Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK
  15. 15 Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMHWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic
  16. 16 National Immunization Programme, Ministry of Health, Vientiane, Lao People’s Democratic Republic
  17. 17 Department of Microbiology and Immunology, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
  18. 18 Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK
  19. 19 Centre for International Child Health, Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Dr Jocelyn Chan; jocelyn.chan{at}mcri.edu.au

Abstract

Introduction Pneumococcal conjugate vaccines (PCVs) prevent disease through both direct protection of vaccinated individuals and indirect protection of unvaccinated individuals by reducing nasopharyngeal (NP) carriage and transmission of vaccine-type (VT) pneumococci. While the indirect effects of PCV vaccination are well described, the PCV coverage required to achieve the indirect effects is unknown. We will investigate the relationship between PCV coverage and VT carriage among undervaccinated children using hospital-based NP pneumococcal carriage surveillance at three sites in Asia and the Pacific.

Methods and analysis We are recruiting cases, defined as children aged 2–59 months admitted to participating hospitals with acute respiratory infection in Lao People’s Democratic Republic, Mongolia and Papua New Guinea. Thirteen-valent PCV status is obtained from written records. NP swabs are collected according to standard methods, screened using lytA qPCR and serotyped by microarray. Village-level vaccination coverage, for the resident communities of the recruited cases, is determined using administrative data or community survey. Our analysis will investigate the relationship between VT carriage among undervaccinated cases (indirect effects) and vaccine coverage using generalised estimating equations.

Ethics and dissemination Ethical approval has been obtained from the relevant ethics committees at participating sites. The results are intended for publication in open-access peer-reviewed journals and will demonstrate methods suitable for low- and middle-income countries to monitor vaccine impact and inform vaccine policy makers about the PCV coverage required to achieve indirect protection.

  • public health
  • respiratory infections

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors FMR conceived the idea and designed the study. JYRL, SD, KF, PNN, RL, RP, AX, DABD and FMR supported the development of country-specific protocols and study implementation in Lao PDR. CCB, RF, DL, WP and FMR supported the development of country-specific protocols and study implementation in PNG. TM, SLV, CvM, KM, JC and FR supported the development of country-specific protocols and study implementation in Mongolia. CS, EMD and JH devised the microbiological approach and laboratory protocols. JC, CDN, RA and FR devised the analysis plan. JC and FR drafted the manuscript. All authors provided feedback to the draft manuscript and have read and approved the final version.

  • Funding This work is supported by the Bill & Melinda Gates Foundation grant number (OPP1115490). JC is completing a PhD at The University of Melbourne, funded by an Australian Government Research Training Program scholarship.

  • Competing interests None declared.

  • Patient consent Guardian consent obtained.

  • Ethics approval The study is being conducted according to protocols approved by the following ethics committees: Lao PDR Ministry of Health National Ethics Committee for Health Research (057/2013 NECHR), Oxford Tropical Research Ethics Committee (1050-13), Mongolian National Ethics Committee for Health Research, the WHO Regional Office for the Western Pacific (WPRO) Ethics Review Committee (2013.30.LAO.2.EPI, Mongolia), PNG IMR Institutional Review Board (1510), Government of PNG Medical Research Advisory Committee (15.18) and the Royal Children’s Hospital/MCRI Human Research Ethics Committee (33177B and 33203E).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement We have an agreement with Bill & Melinda Gates Foundation to share datasets that are requested by non-profit institutions and/or scientific researchers for a particular purpose, such as a meta-analysis or systematic review. We would make them available after ensuring appropriate ethical considerations. Proposals should be directed to Associate Professor Fiona Russell (fmruss@unimelb.edu.au).

  • Collaborators The PneuCAPTIVE protocol development group includes the authors of the paper listed in the byline and the following: Dashtseren Luvsantseren (NCCD, Ulaanbaatar, Mongolia), Bujinlkham Suuri (NCCD, Ulaanbaatar, Mongolia), Mukhchuluun Ulziibayar (NCCD, Ulaanbaatar, Mongolia), Dashpagam Otgonbayer (NCCD, Ulaanbaatar, Mongolia), Audrey Dubot-Pérès (LOMHWRU, Vientiane, Lao PDR), Keodomphone Vilavong (LOMHWRU, Vientiane, Lao PDR), Anisone Chanthongthip (LOMHWRU, Vientiane, Lao PDR), Syladeth Chanthaphone (LOMHWRU, Vientiane, Lao PDR), Joycelyn Sapura (PNG IMR, Goroka, PNG), John Kave (PNG IMR, Goroka, PNG), Tonny Kumani (PNG IMR, Goroka, PNG) and Wendy Kirarock (PNG IMR, Goroka, PNG).

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