Target product profile for a dengue pre-vaccination screening test.

With increasing geographic spread, frequency, and magnitude of outbreaks, dengue continues to pose a major public health threat worldwide. Dengvaxia, a dengue live-attenuated tetravalent vaccine, was licensed in 2015, but post hoc analyses of long-term data showed serostatus-dependent vaccine perfor...

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Autores principales:	Noah Fongwen, Annelise Wilder-Smith, Duane J Gubler, Eng Eong Ooi, Edsel Maurice T Salvana, Xavier de Lamballerie, Piero L Olliaro, Rosanna W Peeling
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/82bcccb1f74047b5a508563f3ef48ace
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spelling	oai:doaj.org-article:82bcccb1f74047b5a508563f3ef48ace2021-12-02T20:23:43ZTarget product profile for a dengue pre-vaccination screening test.1935-27271935-273510.1371/journal.pntd.0009557https://doaj.org/article/82bcccb1f74047b5a508563f3ef48ace2021-07-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009557https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735With increasing geographic spread, frequency, and magnitude of outbreaks, dengue continues to pose a major public health threat worldwide. Dengvaxia, a dengue live-attenuated tetravalent vaccine, was licensed in 2015, but post hoc analyses of long-term data showed serostatus-dependent vaccine performance with an excess risk of hospitalized and severe dengue in seronegative vaccine recipients. The World Health Organization (WHO) recommended that only persons with evidence of past dengue infection should receive the vaccine. A test for pre-vaccination screening for dengue serostatus is needed. To develop the target product profile (TPP) for a dengue pre-vaccination screening test, face-to-face consultative meetings were organized with follow-up regional consultations. A technical working group was formed to develop consensus on a reference test against which candidate pre-vaccination screening tests could be compared. The group also reviewed current diagnostic landscape and the need to accelerate the evaluation, regulatory approval, and policy development of tests that can identify seropositive individuals and maximize public health impact of vaccination while avoiding the risk of hospitalization in dengue-naive individuals. Pre-vaccination screening strategies will benefit from rapid diagnostic tests (RDTs) that are affordable, sensitive, and specific and can be used at the point of care (POC). The TPP described the minimum and ideal characteristics of a dengue pre-vaccination screening RDT with an emphasis on high specificity. The group also made suggestions for accelerating access to these RDTs through streamlining regulatory approval and policy development. Risk and benefit based on what can be achieved with RDTs meeting minimal and optimal characteristics in the TPP across a range of seroprevalences were defined. The final choice of RDTs in each country will depend on the performance of the RDT, dengue seroprevalence in the target population, tolerance of risk, and cost-effectiveness.Noah FongwenAnnelise Wilder-SmithDuane J GublerEng Eong OoiEdsel Maurice T SalvanaXavier de LamballeriePiero L OlliaroRosanna W PeelingPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 7, p e0009557 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Noah Fongwen Annelise Wilder-Smith Duane J Gubler Eng Eong Ooi Edsel Maurice T Salvana Xavier de Lamballerie Piero L Olliaro Rosanna W Peeling Target product profile for a dengue pre-vaccination screening test.
description	With increasing geographic spread, frequency, and magnitude of outbreaks, dengue continues to pose a major public health threat worldwide. Dengvaxia, a dengue live-attenuated tetravalent vaccine, was licensed in 2015, but post hoc analyses of long-term data showed serostatus-dependent vaccine performance with an excess risk of hospitalized and severe dengue in seronegative vaccine recipients. The World Health Organization (WHO) recommended that only persons with evidence of past dengue infection should receive the vaccine. A test for pre-vaccination screening for dengue serostatus is needed. To develop the target product profile (TPP) for a dengue pre-vaccination screening test, face-to-face consultative meetings were organized with follow-up regional consultations. A technical working group was formed to develop consensus on a reference test against which candidate pre-vaccination screening tests could be compared. The group also reviewed current diagnostic landscape and the need to accelerate the evaluation, regulatory approval, and policy development of tests that can identify seropositive individuals and maximize public health impact of vaccination while avoiding the risk of hospitalization in dengue-naive individuals. Pre-vaccination screening strategies will benefit from rapid diagnostic tests (RDTs) that are affordable, sensitive, and specific and can be used at the point of care (POC). The TPP described the minimum and ideal characteristics of a dengue pre-vaccination screening RDT with an emphasis on high specificity. The group also made suggestions for accelerating access to these RDTs through streamlining regulatory approval and policy development. Risk and benefit based on what can be achieved with RDTs meeting minimal and optimal characteristics in the TPP across a range of seroprevalences were defined. The final choice of RDTs in each country will depend on the performance of the RDT, dengue seroprevalence in the target population, tolerance of risk, and cost-effectiveness.
format	article
author	Noah Fongwen Annelise Wilder-Smith Duane J Gubler Eng Eong Ooi Edsel Maurice T Salvana Xavier de Lamballerie Piero L Olliaro Rosanna W Peeling
author_facet	Noah Fongwen Annelise Wilder-Smith Duane J Gubler Eng Eong Ooi Edsel Maurice T Salvana Xavier de Lamballerie Piero L Olliaro Rosanna W Peeling
author_sort	Noah Fongwen
title	Target product profile for a dengue pre-vaccination screening test.
title_short	Target product profile for a dengue pre-vaccination screening test.
title_full	Target product profile for a dengue pre-vaccination screening test.
title_fullStr	Target product profile for a dengue pre-vaccination screening test.
title_full_unstemmed	Target product profile for a dengue pre-vaccination screening test.
title_sort	target product profile for a dengue pre-vaccination screening test.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/82bcccb1f74047b5a508563f3ef48ace
work_keys_str_mv	AT noahfongwen targetproductprofileforadengueprevaccinationscreeningtest AT annelisewildersmith targetproductprofileforadengueprevaccinationscreeningtest AT duanejgubler targetproductprofileforadengueprevaccinationscreeningtest AT engeongooi targetproductprofileforadengueprevaccinationscreeningtest AT edselmauricetsalvana targetproductprofileforadengueprevaccinationscreeningtest AT xavierdelamballerie targetproductprofileforadengueprevaccinationscreeningtest AT pierololliaro targetproductprofileforadengueprevaccinationscreeningtest AT rosannawpeeling targetproductprofileforadengueprevaccinationscreeningtest
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Target product profile for a dengue pre-vaccination screening test.

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