Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings
Background: Crimean-Congo haemorrhagic fever (CCHF) is a priority emerging pathogen for which a licensed vaccine is not yet available. We aim to assess the feasibility of conducting phase III vaccine efficacy trials and the role of varying transmission dynamics. Methods: We calibrate models of CCHF virus (CCHFV) transmission among livestock and spillover to humans in endemic areas in Afghanistan, Turkey and South Africa. We propose an individual randomised controlled trial targeted to high-risk population, and use the calibrated models to simulate trial cohorts to estimate the minimum necessary number of cases (trial endpoints) to analyse a vaccine with a minimum efficacy of 60%, under different conditions of sample size and follow-up time in the three selected settings. Results: A mean follow-up of 160,000 person-month (75,000–550,000) would be necessary to accrue the required 150 trial endpoints for a target vaccine efficacy of 60 % and clinically defined endpoint, in a setting like Herat, Afghanistan. For Turkey, the same would be achieved with a mean follow-up of 175,000 person-month (50,000–350,000). The results suggest that for South Africa the low endemic transmission levels will not permit achieving the necessary conditions for conducting this trial within a realistic follow-up time. In the scenario of CCHFV vaccine trial designed to capture infection as opposed to clinical case as a trial endpoint, the required person-months is reduced by 70 % to 80 % in Afghanistan and Turkey, and in South Africa, a trial becomes feasible for a large number of person-months of follow-up (>600,000). Increased expected vaccine efficacy > 60 % will reduce the required number of trial endpoints and thus the sample size and follow-time in phase III trials. Conclusions: Underlying endemic transmission levels will play a central role in defining the feasibility of phase III vaccine efficacy trials. Endemic settings in Afghanistan and Turkey offer conditions under which such studies could feasibly be conducted.
id |
dig-cirad-fr-606387 |
---|---|
record_format |
koha |
institution |
CIRAD FR |
collection |
DSpace |
country |
Francia |
countrycode |
FR |
component |
Bibliográfico |
access |
En linea |
databasecode |
dig-cirad-fr |
tag |
biblioteca |
region |
Europa del Oeste |
libraryname |
Biblioteca del CIRAD Francia |
language |
eng |
topic |
fièvre hémorragique de Crimée-Congo épidémiologie modèle de simulation élevage vaccination genre humain virus de la fièvre hémorragique de Crimée-Congo bétail vaccin surveillance épidémiologique transmission des maladies http://aims.fao.org/aos/agrovoc/c_ac826b92 http://aims.fao.org/aos/agrovoc/c_2615 http://aims.fao.org/aos/agrovoc/c_24242 http://aims.fao.org/aos/agrovoc/c_8532 http://aims.fao.org/aos/agrovoc/c_15123 http://aims.fao.org/aos/agrovoc/c_4586 http://aims.fao.org/aos/agrovoc/c_f4435348 http://aims.fao.org/aos/agrovoc/c_4397 http://aims.fao.org/aos/agrovoc/c_8130 http://aims.fao.org/aos/agrovoc/c_16411 http://aims.fao.org/aos/agrovoc/c_2329 http://aims.fao.org/aos/agrovoc/c_7252 http://aims.fao.org/aos/agrovoc/c_163 http://aims.fao.org/aos/agrovoc/c_3081 http://aims.fao.org/aos/agrovoc/c_8013 fièvre hémorragique de Crimée-Congo épidémiologie modèle de simulation élevage vaccination genre humain virus de la fièvre hémorragique de Crimée-Congo bétail vaccin surveillance épidémiologique transmission des maladies http://aims.fao.org/aos/agrovoc/c_ac826b92 http://aims.fao.org/aos/agrovoc/c_2615 http://aims.fao.org/aos/agrovoc/c_24242 http://aims.fao.org/aos/agrovoc/c_8532 http://aims.fao.org/aos/agrovoc/c_15123 http://aims.fao.org/aos/agrovoc/c_4586 http://aims.fao.org/aos/agrovoc/c_f4435348 http://aims.fao.org/aos/agrovoc/c_4397 http://aims.fao.org/aos/agrovoc/c_8130 http://aims.fao.org/aos/agrovoc/c_16411 http://aims.fao.org/aos/agrovoc/c_2329 http://aims.fao.org/aos/agrovoc/c_7252 http://aims.fao.org/aos/agrovoc/c_163 http://aims.fao.org/aos/agrovoc/c_3081 http://aims.fao.org/aos/agrovoc/c_8013 |
spellingShingle |
fièvre hémorragique de Crimée-Congo épidémiologie modèle de simulation élevage vaccination genre humain virus de la fièvre hémorragique de Crimée-Congo bétail vaccin surveillance épidémiologique transmission des maladies http://aims.fao.org/aos/agrovoc/c_ac826b92 http://aims.fao.org/aos/agrovoc/c_2615 http://aims.fao.org/aos/agrovoc/c_24242 http://aims.fao.org/aos/agrovoc/c_8532 http://aims.fao.org/aos/agrovoc/c_15123 http://aims.fao.org/aos/agrovoc/c_4586 http://aims.fao.org/aos/agrovoc/c_f4435348 http://aims.fao.org/aos/agrovoc/c_4397 http://aims.fao.org/aos/agrovoc/c_8130 http://aims.fao.org/aos/agrovoc/c_16411 http://aims.fao.org/aos/agrovoc/c_2329 http://aims.fao.org/aos/agrovoc/c_7252 http://aims.fao.org/aos/agrovoc/c_163 http://aims.fao.org/aos/agrovoc/c_3081 http://aims.fao.org/aos/agrovoc/c_8013 fièvre hémorragique de Crimée-Congo épidémiologie modèle de simulation élevage vaccination genre humain virus de la fièvre hémorragique de Crimée-Congo bétail vaccin surveillance épidémiologique transmission des maladies http://aims.fao.org/aos/agrovoc/c_ac826b92 http://aims.fao.org/aos/agrovoc/c_2615 http://aims.fao.org/aos/agrovoc/c_24242 http://aims.fao.org/aos/agrovoc/c_8532 http://aims.fao.org/aos/agrovoc/c_15123 http://aims.fao.org/aos/agrovoc/c_4586 http://aims.fao.org/aos/agrovoc/c_f4435348 http://aims.fao.org/aos/agrovoc/c_4397 http://aims.fao.org/aos/agrovoc/c_8130 http://aims.fao.org/aos/agrovoc/c_16411 http://aims.fao.org/aos/agrovoc/c_2329 http://aims.fao.org/aos/agrovoc/c_7252 http://aims.fao.org/aos/agrovoc/c_163 http://aims.fao.org/aos/agrovoc/c_3081 http://aims.fao.org/aos/agrovoc/c_8013 Vesga, Juan F. Métras, Raphaëlle Clark, Madeleine H.A. Ayazi, Edris Apolloni, Andrea Leslie, Toby Msimang, Veerle Thompson, Peter Edmunds, John W. Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings |
description |
Background: Crimean-Congo haemorrhagic fever (CCHF) is a priority emerging pathogen for which a licensed vaccine is not yet available. We aim to assess the feasibility of conducting phase III vaccine efficacy trials and the role of varying transmission dynamics. Methods: We calibrate models of CCHF virus (CCHFV) transmission among livestock and spillover to humans in endemic areas in Afghanistan, Turkey and South Africa. We propose an individual randomised controlled trial targeted to high-risk population, and use the calibrated models to simulate trial cohorts to estimate the minimum necessary number of cases (trial endpoints) to analyse a vaccine with a minimum efficacy of 60%, under different conditions of sample size and follow-up time in the three selected settings. Results: A mean follow-up of 160,000 person-month (75,000–550,000) would be necessary to accrue the required 150 trial endpoints for a target vaccine efficacy of 60 % and clinically defined endpoint, in a setting like Herat, Afghanistan. For Turkey, the same would be achieved with a mean follow-up of 175,000 person-month (50,000–350,000). The results suggest that for South Africa the low endemic transmission levels will not permit achieving the necessary conditions for conducting this trial within a realistic follow-up time. In the scenario of CCHFV vaccine trial designed to capture infection as opposed to clinical case as a trial endpoint, the required person-months is reduced by 70 % to 80 % in Afghanistan and Turkey, and in South Africa, a trial becomes feasible for a large number of person-months of follow-up (>600,000). Increased expected vaccine efficacy > 60 % will reduce the required number of trial endpoints and thus the sample size and follow-time in phase III trials. Conclusions: Underlying endemic transmission levels will play a central role in defining the feasibility of phase III vaccine efficacy trials. Endemic settings in Afghanistan and Turkey offer conditions under which such studies could feasibly be conducted. |
format |
article |
topic_facet |
fièvre hémorragique de Crimée-Congo épidémiologie modèle de simulation élevage vaccination genre humain virus de la fièvre hémorragique de Crimée-Congo bétail vaccin surveillance épidémiologique transmission des maladies http://aims.fao.org/aos/agrovoc/c_ac826b92 http://aims.fao.org/aos/agrovoc/c_2615 http://aims.fao.org/aos/agrovoc/c_24242 http://aims.fao.org/aos/agrovoc/c_8532 http://aims.fao.org/aos/agrovoc/c_15123 http://aims.fao.org/aos/agrovoc/c_4586 http://aims.fao.org/aos/agrovoc/c_f4435348 http://aims.fao.org/aos/agrovoc/c_4397 http://aims.fao.org/aos/agrovoc/c_8130 http://aims.fao.org/aos/agrovoc/c_16411 http://aims.fao.org/aos/agrovoc/c_2329 http://aims.fao.org/aos/agrovoc/c_7252 http://aims.fao.org/aos/agrovoc/c_163 http://aims.fao.org/aos/agrovoc/c_3081 http://aims.fao.org/aos/agrovoc/c_8013 |
author |
Vesga, Juan F. Métras, Raphaëlle Clark, Madeleine H.A. Ayazi, Edris Apolloni, Andrea Leslie, Toby Msimang, Veerle Thompson, Peter Edmunds, John W. |
author_facet |
Vesga, Juan F. Métras, Raphaëlle Clark, Madeleine H.A. Ayazi, Edris Apolloni, Andrea Leslie, Toby Msimang, Veerle Thompson, Peter Edmunds, John W. |
author_sort |
Vesga, Juan F. |
title |
Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings |
title_short |
Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings |
title_full |
Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings |
title_fullStr |
Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings |
title_full_unstemmed |
Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings |
title_sort |
vaccine efficacy trials for crimean-congo haemorrhagic fever: insights from modelling different epidemiological settings |
url |
http://agritrop.cirad.fr/606387/ http://agritrop.cirad.fr/606387/1/ID606387.pdf |
work_keys_str_mv |
AT vesgajuanf vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT metrasraphaelle vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT clarkmadeleineha vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT ayaziedris vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT apolloniandrea vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT leslietoby vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT msimangveerle vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT thompsonpeter vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings AT edmundsjohnw vaccineefficacytrialsforcrimeancongohaemorrhagicfeverinsightsfrommodellingdifferentepidemiologicalsettings |
_version_ |
1798165109462269952 |
spelling |
dig-cirad-fr-6063872024-04-25T08:24:01Z http://agritrop.cirad.fr/606387/ http://agritrop.cirad.fr/606387/ Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings. Vesga Juan F., Métras Raphaëlle, Clark Madeleine H.A., Ayazi Edris, Apolloni Andrea, Leslie Toby, Msimang Veerle, Thompson Peter, Edmunds John W.. 2022. Vaccine, 40 (40) : 5806-5813.https://doi.org/10.1016/j.vaccine.2022.08.061 <https://doi.org/10.1016/j.vaccine.2022.08.061> Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings Vesga, Juan F. Métras, Raphaëlle Clark, Madeleine H.A. Ayazi, Edris Apolloni, Andrea Leslie, Toby Msimang, Veerle Thompson, Peter Edmunds, John W. eng 2022 Vaccine fièvre hémorragique de Crimée-Congo épidémiologie modèle de simulation élevage vaccination genre humain virus de la fièvre hémorragique de Crimée-Congo bétail vaccin surveillance épidémiologique transmission des maladies http://aims.fao.org/aos/agrovoc/c_ac826b92 http://aims.fao.org/aos/agrovoc/c_2615 http://aims.fao.org/aos/agrovoc/c_24242 http://aims.fao.org/aos/agrovoc/c_8532 http://aims.fao.org/aos/agrovoc/c_15123 http://aims.fao.org/aos/agrovoc/c_4586 http://aims.fao.org/aos/agrovoc/c_f4435348 http://aims.fao.org/aos/agrovoc/c_4397 http://aims.fao.org/aos/agrovoc/c_8130 http://aims.fao.org/aos/agrovoc/c_16411 http://aims.fao.org/aos/agrovoc/c_2329 Afrique du Sud Afghanistan France Türkiye http://aims.fao.org/aos/agrovoc/c_7252 http://aims.fao.org/aos/agrovoc/c_163 http://aims.fao.org/aos/agrovoc/c_3081 http://aims.fao.org/aos/agrovoc/c_8013 Background: Crimean-Congo haemorrhagic fever (CCHF) is a priority emerging pathogen for which a licensed vaccine is not yet available. We aim to assess the feasibility of conducting phase III vaccine efficacy trials and the role of varying transmission dynamics. Methods: We calibrate models of CCHF virus (CCHFV) transmission among livestock and spillover to humans in endemic areas in Afghanistan, Turkey and South Africa. We propose an individual randomised controlled trial targeted to high-risk population, and use the calibrated models to simulate trial cohorts to estimate the minimum necessary number of cases (trial endpoints) to analyse a vaccine with a minimum efficacy of 60%, under different conditions of sample size and follow-up time in the three selected settings. Results: A mean follow-up of 160,000 person-month (75,000–550,000) would be necessary to accrue the required 150 trial endpoints for a target vaccine efficacy of 60 % and clinically defined endpoint, in a setting like Herat, Afghanistan. For Turkey, the same would be achieved with a mean follow-up of 175,000 person-month (50,000–350,000). The results suggest that for South Africa the low endemic transmission levels will not permit achieving the necessary conditions for conducting this trial within a realistic follow-up time. In the scenario of CCHFV vaccine trial designed to capture infection as opposed to clinical case as a trial endpoint, the required person-months is reduced by 70 % to 80 % in Afghanistan and Turkey, and in South Africa, a trial becomes feasible for a large number of person-months of follow-up (>600,000). Increased expected vaccine efficacy > 60 % will reduce the required number of trial endpoints and thus the sample size and follow-time in phase III trials. Conclusions: Underlying endemic transmission levels will play a central role in defining the feasibility of phase III vaccine efficacy trials. Endemic settings in Afghanistan and Turkey offer conditions under which such studies could feasibly be conducted. article info:eu-repo/semantics/article Journal Article info:eu-repo/semantics/publishedVersion http://agritrop.cirad.fr/606387/1/ID606387.pdf text cc_by info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by/4.0/ https://doi.org/10.1016/j.vaccine.2022.08.061 10.1016/j.vaccine.2022.08.061 info:eu-repo/semantics/altIdentifier/doi/10.1016/j.vaccine.2022.08.061 info:eu-repo/semantics/altIdentifier/purl/https://doi.org/10.1016/j.vaccine.2022.08.061 info:eu-repo/semantics/reference/purl/https://github.com/juanvesga/cchfv-vaccine-trial-multicountry |