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

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Abstract

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).

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The REDCap consortium: Building an international community of software platform partners

Paul Harris, Robert Taylor, Brenda Minor … (2019)

The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.

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The global burden of typhoid and paratyphoid fevers: a systematic analysis for the Global Burden of Disease Study 2017

Jeffrey D Stanaway, Robert Reiner, Brigette F Blacker … (2019)

Summary Background Efforts to quantify the global burden of enteric fever are valuable for understanding the health lost and the large-scale spatial distribution of the disease. We present the estimates of typhoid and paratyphoid fever burden from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2017, and the approach taken to produce them. Methods For this systematic analysis we broke down the relative contributions of typhoid and paratyphoid fevers by country, year, and age, and analysed trends in incidence and mortality. We modelled the combined incidence of typhoid and paratyphoid fevers and split these total cases proportionally between typhoid and paratyphoid fevers using aetiological proportion models. We estimated deaths using vital registration data for countries with sufficiently high data completeness and using a natural history approach for other locations. We also estimated disability-adjusted life-years (DALYs) for typhoid and paratyphoid fevers. Findings Globally, 14·3 million (95% uncertainty interval [UI] 12·5–16·3) cases of typhoid and paratyphoid fevers occurred in 2017, a 44·6% (42·2–47·0) decline from 25·9 million (22·0–29·9) in 1990. Age-standardised incidence rates declined by 54·9% (53·4–56·5), from 439·2 (376·7–507·7) per 100 000 person-years in 1990, to 197·8 (172·0–226·2) per 100 000 person-years in 2017. In 2017, Salmonella enterica serotype Typhi caused 76·3% (71·8–80·5) of cases of enteric fever. We estimated a global case fatality of 0·95% (0·54–1·53) in 2017, with higher case fatality estimates among children and older adults, and among those living in lower-income countries. We therefore estimated 135·9 thousand (76·9–218·9) deaths from typhoid and paratyphoid fever globally in 2017, a 41·0% (33·6–48·3) decline from 230·5 thousand (131·2–372·6) in 1990. Overall, typhoid and paratyphoid fevers were responsible for 9·8 million (5·6–15·8) DALYs in 2017, down 43·0% (35·5–50·6) from 17·2 million (9·9–27·8) DALYs in 1990. Interpretation Despite notable progress, typhoid and paratyphoid fevers remain major causes of disability and death, with billions of people likely to be exposed to the pathogens. Although improvements in water and sanitation remain essential, increased vaccine use (including with typhoid conjugate vaccines that are effective in infants and young children and protective for longer periods) and improved data and surveillance to inform vaccine rollout are likely to drive the greatest improvements in the global burden of the disease. Funding Bill & Melinda Gates Foundation.

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Typhoid vaccines: WHO position paper, March 2018 – Recommendations

World Health Organization (2018)

This article presented the World Health Organization's (WHO) recommendations on the use of Typhoid vaccines excerpted from the Typhoid vaccines: WHO position paper - March 2018 published in the Weekly Epidemiological Record (World Health Organization, 2018) [1]. This position paper replaces the 2008 WHO position paper on typhoid vaccines (WHO, 2008) [2]. It re-emphasizes the importance of vaccination to control typhoid fever and presents the WHO recommendations on the use of a new generation of typhoid conjugate vaccines. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation tables. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. Recommendations on the use of cholera vaccines were discussed by the Strategic Advisory Group of Experts (SAGE) in October 2017; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/meetings/2017/October/presentations_background_docs/en/.

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Author and article information

Contributors

Ralph A. Tripp: Role: Academic Editor

Journal

Journal ID (nlm-ta): Vaccines (Basel)

Journal ID (iso-abbrev): Vaccines (Basel)

Journal ID (publisher-id): vaccines

Title: Vaccines

Publisher: MDPI

ISSN (Electronic): 2076-393X

Publication date (Electronic): 19 March 2021

Publication date Collection: March 2021

Volume: 9

Issue: 3

Electronic Location Identifier: 281

Affiliations

[1 ]International Vaccine Institute, Seoul 08826, Korea; birkneh.tadesse@ 123456ivi.int (B.T.T.); juyeon.park@ 123456ivi.int (J.P.); lcruz@ 123456ivi.int (L.M.C.E.); ariane.abreu@ 123456ivi.int (A.A.); craig.rensburg@ 123456ivi.int (C.V.R.); hyonjin.jeon@ 123456ivi.int (H.J.); sunju.park@ 123456ivi.int (S.P.); zenaida.mojares@ 123456ivi.int (Z.R.M.); justin.im@ 123456ivi.int (J.I.); drkim@ 123456ivi.int (D.K.); vmogasale@ 123456ivi.int (V.M.); jclemens@ 123456icddrb.org (J.C.)

[2 ]Cambridge Institute for Therapeutic Immunology and Infectious Disease, University of Cambridge, Cambridge CB2 0SL, UK; eeh48@ 123456cam.ac.uk (E.H.); mec82@ 123456cam.ac.uk (M.E.C.); st823@ 123456cam.ac.uk (S.T.); gd312@ 123456medschl.cam.ac.uk (G.D.)

[3 ]Department of Infectious Disease, Imperial College of Medicine, London SW7 2AZ, UK; m.gibani@ 123456imperial.ac.uk

[4 ]School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi 00000, Ghana; mikeansah@ 123456yahoo.com (M.O.-A.); sampson.ankrah@ 123456yahoo.com (S.T.-A.); michaelowusu80@ 123456gmail.com (M.O.); isaacaguna98@ 123456gmail.com (I.A.); yasax@ 123456hotmail.co.uk (Y.A.-S.); owusudabo@ 123456yahoo.com (E.O.-D.)

[5 ]Fondation Mérieux, 69002 Lyon, France; valentina.picot@ 123456fondation-merieux.org

[6 ]International Centre for Diarrhoeal Disease Research, Dhaka 1212, Bangladesh; farhanak@ 123456icddrb.org (F.K.); fqadri@ 123456icddrb.org (F.Q.)

[7 ]Seattle Epidemiologic Research and Information Center, Cooperative Studies Program, Office of Research and Development, United States Department of Veterans Affairs, Seattle, WA 98174, USA; jons@ 123456fredhutch.org

[8 ]Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA

[9 ]Department of Epidemiology, University of Washington, Seattle, WA 98195, USA

[10 ]Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD 21201, USA; kneuzil@ 123456som.umaryland.edu

[11 ]Fielding School of Public Health, University of California, Los Angeles, CA 90095, USA

[12 ]Laboratory of Microbiology and Parasitology, University of Antananarivo, Antananarivo 566, Madagascar

Author notes

[* ]Correspondence: andrea.haselbeck@ 123456ivi.int (A.H.H.); fmarks@ 123456ivi.int (F.M.)

[†]

Equal contribution.

Author information

Andrea Haekyung Haselbeck https://orcid.org/0000-0003-1740-0011

Malick M. Gibani https://orcid.org/0000-0003-1781-0053

Ligia María Cruz Espinoza https://orcid.org/0000-0003-0429-4723

Ariane Abreu https://orcid.org/0000-0002-5599-0991

Michael Owusu-Ansah https://orcid.org/0000-0003-3631-0564

Hyonjin Jeon https://orcid.org/0000-0002-2344-4574

Vittal Mogasale https://orcid.org/0000-0003-0596-8072

Yaw Adu-Sarkodie https://orcid.org/0000-0003-2093-1534

Florian Marks https://orcid.org/0000-0002-6043-7170

Article

Publisher ID: vaccines-09-00281

DOI: 10.3390/vaccines9030281

PMC ID: 8003794

SO-VID: 71416b98-ba78-4177-9898-e0068424df8a

License:

Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

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

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Malaria vaccine development

Most cited references 33

The REDCap consortium: Building an international community of software platform partners

The global burden of typhoid and paratyphoid fevers: a systematic analysis for the Global Burden of Disease Study 2017

Typhoid vaccines: WHO position paper, March 2018 – Recommendations

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