Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA) using a Cluster-Randomized Controlled Phase IV Trial: Trial Design and Population Baseline Characteristics

Vaccines

Gordon Dougan¹  Susan Tonks¹  MeganE. Carey¹  Ellen Higginson¹  Kathleen Neuzil²  MalickM. Gibani³  Valentina Picot⁴  Firdausi Qadri⁵  Farhana Khanam⁵  CraigVan Rensburg⁶  Hyonjin Jeon⁶  Sunju Park⁶  BirknehTilahun Tadesse⁶  Ariane Abreu⁶  ZenaidaR. Mojares⁶  Florian Marks⁶  AndreaHaekyung Haselbeck⁶  Deokryun Kim⁶  John Clemens⁶  Justin Im⁶  Juyeon Park⁶  Vittal Mogasale⁶  LigiaMaría Cruz Espinoza⁶  Sampson Twuamsi-Ankrah⁷  Isaac Aguna⁷  Michael Owusu⁷  Michael Owusu-Ansah⁷  Yaw Adu-Sarkodie⁷  Ellis Owusu-Dabo⁷  Jonathan Sugimoto⁸ 

[1] Cambridge Institute for Therapeutic Immunology and Infectious Disease, University of Cambridge, Cambridge CB2 0SL, UK;Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD 21201, USA;Department of Infectious Disease, Imperial College of Medicine, London SW7 2AZ, UK;Fondation Mérieux, 69002 Lyon, France;International Centre for Diarrhoeal Disease Research, Dhaka 1212, Bangladesh;International Vaccine Institute, Seoul 08826, Korea;School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi 00000, Ghana;Seattle Epidemiologic Research and Information Center, Cooperative Studies Program, Office of Research and Development, United States Department of Veterans Affairs, Seattle, WA 98174, USA;

关键词: typhoid conjugate vaccine;    typhoid fever;    cluster randomized trial;    Ghana;   

DOI  :  10.3390/vaccines9030281

来源: DOAJ

【 摘 要 】

Typhoid fever remains a significant health problem in sub-Saharan Africa, with incidence rates of >100 cases per 100,000 person-years of observation. Despite the prequalification of safe and effective typhoid conjugate vaccines (TCV), some uncertainties remain around future demand. Real-life effectiveness data, which inform public health programs on the impact of TCVs in reducing typhoid-related mortality and morbidity, from an African setting may help encourage the introduction of TCVs in high-burden settings. Here, we describe a cluster-randomized trial to investigate population-level protection of TYPBAR-TCV^®, a Vi-polysaccharide conjugated to a tetanus-toxoid protein carrier (Vi-TT) against blood-culture-confirmed typhoid fever, and the synthesis of health economic evidence to inform policy decisions. A total of 80 geographically distinct clusters are delineated within the Agogo district of the Asante Akim region in Ghana. Clusters are randomized to the intervention arm receiving Vi-TT or a control arm receiving the meningococcal A conjugate vaccine. The primary study endpoint is the total protection of Vi-TT against blood-culture-confirmed typhoid fever. Total, direct, and indirect protection are measured as secondary outcomes. Blood-culture-based enhanced surveillance enables the estimation of incidence rates in the intervention and control clusters. Evaluation of the real-world impact of TCVs and evidence synthesis improve the uptake of prequalified/licensed safe and effective typhoid vaccines in public health programs of high burden settings. This trial is registered at the Pan African Clinical Trial Registry, accessible at Pan African Clinical Trials Registry (ID: PACTR202011804563392).

【 授权许可】

Unknown