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

Gates Open Research

article

Lay-Myint Yoshida¹  Stefan Flasche²  Kim Mulholland³  Hien-Anh Nguyen⁵  Cattram Nguyen⁴  Michiko Toizumi¹  Duc-Anh Dang⁵ 

[1] Department of Pediatric Infectious Diseases, Institute of Tropical Medicine, Nagasaki University;Centre For Mathematical Modelling of Infectious Diseases, London School of Hygiene and Tropical Medicine;Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine;Department of Infection and Immunity;Department of Bacteriology, National Institute of Hygiene and Epidemiology

关键词: Pneumococcal conjugate vaccine (PCV);    Reduced dosing schedule;    Vietnam;    vaccine trial;   

DOI  :  10.12688/gatesopenres.14742.1

学科分类：电子与电气工程

来源: American Journal Of Pharmtech Research

【 摘 要 】

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.

【 授权许可】

CC BY