Simplified 0+1 and 1+1 pneumococcal vaccine schedules in Ho Chi Minh City, Vietnam: protocol for a randomised controlled trial

Beth Temple, Hau Phuc Tran, Vo Thi Trang Dai, Kathryn Bright, Doan Y Uyen, Anne Balloch, Paul Licciardi, Cattram Duong Nguyen, Catherine Satzke, Heidi Smith-Vaughan, Thuong Vu Nguyen, Kim Mulholland, Beth Temple, Hau Phuc Tran, Vo Thi Trang Dai, Kathryn Bright, Doan Y Uyen, Anne Balloch, Paul Licciardi, Cattram Duong Nguyen, Catherine Satzke, Heidi Smith-Vaughan, Thuong Vu Nguyen, Kim Mulholland

Abstract

Introduction: Reduced-dose schedules offer a more efficient and affordable way to use pneumococcal conjugate vaccines (PCVs). Such schedules rely primarily on the maintenance of herd protection. The Vietnam Pneumococcal Trial II (VPT-II) will evaluate reduced-dose schedules of PCV10 and PCV13 utilising an unvaccinated control group. Schedules will be compared in relation to their effect on nasopharyngeal carriage and immunogenicity.

Methods and analysis: VPT-II is a single-blind open-label randomised controlled trial of 2500 infants in three districts of Ho Chi Minh City, Vietnam. Eligible infants have no clinically significant maternal or perinatal history and are born at or after 36 weeks' gestation. Participants are recruited at 2 months of age and randomly assigned (4:4:4:4:9) using block randomisation, stratified by district, to one of five groups: four intervention groups that receive PCV10 in a 0+1 (at 12 months) or 1+1 (at 2 and 12 months) schedule or PCV13 in the same 0+1 or 1+1 schedule; and a control group (that receives a single dose of PCV10 at 24 months). Participants are followed up to 24 months of age. The primary outcome is vaccine-type pneumococcal carriage at 24 months of age. Secondary outcomes are carriage at 6, 12 and 18 months of age and the comparative immunogenicity of the different schedules in terms of antibody responses, functional antibody responses and memory B cell responses.

Ethics and dissemination: Ethical approval has been obtained from the Human Research Ethics Committee of the Royal Children's Hospital Melbourne and the Vietnam Ministry of Health Ethics Committee. The results, interpretation and conclusions will be presented to parents and guardians, at national and international conferences and published in peer-reviewed open access journals.

Trial registration number: NCT03098628.

Keywords: clinical trials; immunology; microbiology; paediatric infectious disease & immunisation.

Conflict of interest statement

Competing interests: All authors receive salary support from grants from the Bill & Melinda Gates Foundation. KM, CS and CDN are investigators on a collaborative study on PCV impact on adult pneumonia funded by Pfizer.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

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