Fongwen, Noah; Wilder-Smith, Annelise; Gubler, Duane J; Ooi, Eng Eong; T Salvana, Edsel Maurice; de Lamballerie, Xavier; Olliaro, Piero L; Peeling, Rosanna W (2021). Target product profile for a dengue pre-vaccination screening test. PLoS neglected tropical diseases, 15(7), e0009557. Public Library of Science 10.1371/journal.pntd.0009557
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Fongwen_PLoSNeglTropDis_2021.pdf - Published Version Available under License Creative Commons: Attribution (CC-BY). Download (728kB) | Preview |
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.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM) |
UniBE Contributor: |
Wilder-Smith, Annelies |
Subjects: |
600 Technology > 610 Medicine & health 300 Social sciences, sociology & anthropology > 360 Social problems & social services |
ISSN: |
1935-2727 |
Publisher: |
Public Library of Science |
Language: |
English |
Submitter: |
Andrea Flükiger-Flückiger |
Date Deposited: |
04 Aug 2021 18:26 |
Last Modified: |
15 Feb 2024 15:51 |
Publisher DOI: |
10.1371/journal.pntd.0009557 |
PubMed ID: |
34324505 |
BORIS DOI: |
10.48350/157917 |
URI: |
https://boris.unibe.ch/id/eprint/157917 |
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