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

1
International Vaccine Institute, Seoul 08826, Korea
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Cambridge Institute for Therapeutic Immunology and Infectious Disease, University of Cambridge, Cambridge CB2 0SL, UK
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Department of Infectious Disease, Imperial College of Medicine, London SW7 2AZ, UK
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School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi 00000, Ghana
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Fondation Mérieux, 69002 Lyon, France
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International Centre for Diarrhoeal Disease Research, Dhaka 1212, Bangladesh
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Seattle Epidemiologic Research and Information Center, Cooperative Studies Program, Office of Research and Development, United States Department of Veterans Affairs, Seattle, WA 98174, USA
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Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA
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Department of Epidemiology, University of Washington, Seattle, WA 98195, USA
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Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD 21201, USA
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Fielding School of Public Health, University of California, Los Angeles, CA 90095, USA
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Laboratory of Microbiology and Parasitology, University of Antananarivo, Antananarivo 566, Madagascar
*
Authors to whom correspondence should be addressed.
Equal contribution.
Academic Editor: Ralph A. Tripp
Vaccines 2021, 9(3), 281; https://doi.org/10.3390/vaccines9030281
Received: 10 February 2021 / Revised: 12 March 2021 / Accepted: 15 March 2021 / Published: 19 March 2021
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). View Full-Text
Keywords: typhoid conjugate vaccine; typhoid fever; cluster randomized trial; Ghana typhoid conjugate vaccine; typhoid fever; cluster randomized trial; Ghana
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MDPI and ACS Style

Haselbeck, A.H.; Tadesse, B.T.; Park, J.; Gibani, M.M.; Espinoza, L.M.C.; Abreu, A.; Van Rensburg, C.; Owusu-Ansah, M.; Twuamsi-Ankrah, S.; Owusu, M.; Aguna, I.; Picot, V.; Jeon, H.; Higginson, E.; Park, S.; Mojares, Z.R.; Im, J.; Carey, M.E.; Khanam, F.; Tonks, S.; Dougan, G.; Kim, D.; Sugimoto, J.; Mogasale, V.; Neuzil, K.M.; Qadri, F.; Adu-Sarkodie, Y.; Owusu-Dabo, E.; Clemens, J.; Marks, F. Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA) Using a Cluster-Randomized Controlled Phase IV Trial: Trial Design and Population Baseline Characteristics. Vaccines 2021, 9, 281. https://doi.org/10.3390/vaccines9030281

AMA Style

Haselbeck AH, Tadesse BT, Park J, Gibani MM, Espinoza LMC, Abreu A, Van Rensburg C, Owusu-Ansah M, Twuamsi-Ankrah S, Owusu M, Aguna I, Picot V, Jeon H, Higginson E, Park S, Mojares ZR, Im J, Carey ME, Khanam F, Tonks S, Dougan G, Kim D, Sugimoto J, Mogasale V, Neuzil KM, Qadri F, Adu-Sarkodie Y, Owusu-Dabo E, Clemens J, Marks F. Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA) Using a Cluster-Randomized Controlled Phase IV Trial: Trial Design and Population Baseline Characteristics. Vaccines. 2021; 9(3):281. https://doi.org/10.3390/vaccines9030281

Chicago/Turabian Style

Haselbeck, Andrea H., Birkneh T. Tadesse, Juyeon Park, Malick M. Gibani, Ligia M.C. Espinoza, Ariane Abreu, Craig Van Rensburg, Michael Owusu-Ansah, Sampson Twuamsi-Ankrah, Michael Owusu, Isaac Aguna, Valentina Picot, Hyonjin Jeon, Ellen Higginson, Sunju Park, Zenaida R. Mojares, Justin Im, Megan E. Carey, Farhana Khanam, Susan Tonks, Gordon Dougan, Deokryun Kim, Jonathan Sugimoto, Vittal Mogasale, Kathleen M. Neuzil, Firdausi Qadri, Yaw Adu-Sarkodie, Ellis Owusu-Dabo, John Clemens, and Florian Marks. 2021. "Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA) Using a Cluster-Randomized Controlled Phase IV Trial: Trial Design and Population Baseline Characteristics" Vaccines 9, no. 3: 281. https://doi.org/10.3390/vaccines9030281

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