optimising dengue pre vaccination screening CORD-Papers-2022-06-02 (Version 1)

Title: Optimising dengue pre-vaccination screening
Published: 2020-11-16
Journal: Lancet Infect Dis
DOI: 10.1016/s1473-3099(20)30722-2
DOI_URL: http://doi.org/10.1016/s1473-3099(20)30722-2
Author Name: Wilder Smith Annelies
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wilder_smith_annelies
Author Name: Peeling Rosanna W
Author link: https://covid19-data.nist.gov/pid/rest/local/author/peeling_rosanna_w
sha: 2436283e66bae8c0398568106e9e754933edaba6
license: no-cc
license_url: [no creative commons license associated]
source_x: PMC
source_x_url: https://www.ncbi.nlm.nih.gov/pubmed/
pubmed_id: 33212066
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/33212066
pmcid: PMC7834846
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834846
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834846/
has_full_text: TRUE
Keywords Extracted from Text Content: https://doi flaviviruses OnSite)-for ≤7 virus serotypes plasma COVID-19 children CYD-TDV vaccine CYD15 OnSite CYD-TDV serum Vaccine blood coronavirus 2 hepatitis B people mosquitoes Nile AW-S RDTs TELL ME FAST Zika blood samples participants
Extracted Text Content in Record: First 5000 Characters:www.thelancet.com/infection Published online November 16, 2020 https://doi. Optimising dengue pre-vaccination screening As the world is grappling with the global COVID-19 pandemic, dengue epidemics continue to rage relentlessly in the tropics and subtropics. 1 About 100 million dengue cases are reported every year, often overwhelming already fragile health-care systems, with the highest burden in southeast Asia followed by Latin America. 2 Dengue and COVID-19 have in common that epidemic transmission is driven by population densities, and both are rapidly spread via travellers. 3 The difference between the two diseases is the mode of transmission. The four dengue virus serotypes are transmitted by Aedes spp mosquitoes, which mainly proliferate in the climatic conditions of the tropics and subtropics, 4 whereas severe acute respiratory syndrome coronavirus 2 is transmitted via respiratory droplets ubiquitously. While the scientific community is racing towards developing a vaccine against COVID-19, we already have a vaccine at hand against dengue. First licensed in 2015, the tetravalent live attenuated dengue vaccine developed by Sanofi Pasteur (CYD-TDV, with the trade name of Dengvaxia) was evaluated in more than 30 000 children in ten countries in Asia and Latin America, with now more than 5 years of observation time since administration of the first dose. 5 The combined phase 3 trials showed a moderate-high efficacy, with increasing efficacy with age, serotype 4, and in settings with higher seroprevalence. Further post-hoc analyses with retrospective stratification into baseline serostatus (presence or absence of previous dengue infection at the time of administration of the first dose) revealed that vaccine performance was strongly driven by serostatus: seropositive individuals benefitted from high efficacy, whereas seronegative individuals experienced no statistically significant efficacy but an increase in hospitalised dengue from year 3 onwards after administration of the first dose. 5 Subsequently, WHO recommended that CYD-TDV should only be given to seropositive individuals. Hence screening for dengue serostatus before vaccination is needed. 6 In The Lancet Infectious Diseases, Carlos DiazGranados and colleagues evaluated five commercially available immunoassays-two IgG-based ELISAs (EUROIMMUN and Panbio) and three rapid diagnostic tests (RDTs; TELL ME FAST, SD BIOLINE, and OnSite)-for their potential to classify baseline dengue serostatus, using baseline samples from more than 3000 participants in the immunogenicity subsets of the phase 3 CYD14 and CYD15 efficacy trials. 7 7 These results are encouraging, and consistent with an earlier evaluation of various ELISA against RDTs, in which sensitivities for RDTs were found to generally be lower than those of the ELISAs (≥90%). 8, 9 Those studies also found that sensitivity for the assays evaluated by DiazGranados and colleagues appeared similar in samples from individuals with recent (<13 months) versus remote (3-4 years) virologically confirmed dengue. 8 Additionally, cross-reactivity to other flaviviruses was low with RDTs (≤7%), but more significant with ELISAs (up to 51% for West Nile and 34% for Zika). 8 DiazGranados and colleagues also re-evaluated CYD-TDV vaccine efficacy in participants identified as dengue seropositive by the five immunoassays. 7 Vaccine efficacy against symptomatic virologically confirmed dengue in immunoassay-positive participants was high across all five immunoassays (from 82·8% [95% CI 66·9-91·1] by SD BIOLINE RDT to 89·7% [64·6-97·0] by OnSite RDT), as was vaccine efficacy against hospitalised virologically confirmed dengue (from 72·8% [38·9-87·9] by EUROIMMUN ELISA to 92·4% [37·8-99·1] by TELL ME FAST RDT), underpinning the public health usefulness of the first licensed dengue vaccine. Vaccine efficacy against severe virologically confirmed dengue was similarly high, but lacked precision owing to very few severe virologically confirmed dengue cases over the follow-up. DiazGranados and colleagues' findings suggest that current commercially available immunoassays and RDTs could be used for pre-vaccination screening for CYD-TDV. Although a more sensitive or convenient test would improve the performance and efficiency of pre-vaccination screening programmes, countries can start to choose from existing screening tests for their vaccination programmes. The key considerations for selection are accuracy, ease of use, and affordability. Ideally, a screening test should be both highly sensitive and specific to minimise false positives and negatives to yield maximal population level benefit and minimise harm by correctly screening for seropositive individuals only. 6 It should also be affordable, simple to use, and provide a rapid result so that vaccination can be given immediately after serostatus is confirmed. RDTs fulfil these ease-of-use requirements as they can use finger-pricked blood samples and the test can be done outside o
Keywords Extracted from PMC Text: OnSite 15–20 ≤7 plasma CYD-TDV vaccine RDTs dengue.8 OnSite)—for TELL ME FAST 50·6 Vaccine needed.6 virus serotypes mosquitoes Nile hepatitis B children blood samples flaviviruses subtropics,4 COVID-19 participants blood Zika).8 people immunoassays.7 Vaccine CYD-TDV CYD15 54·4 serum
Extracted PMC Text Content in Record: First 5000 Characters:As the world is grappling with the global COVID-19 pandemic, dengue epidemics continue to rage relentlessly in the tropics and subtropics.1 About 100 million dengue cases are reported every year, often overwhelming already fragile health-care systems, with the highest burden in southeast Asia followed by Latin America.2 Dengue and COVID-19 have in common that epidemic transmission is driven by population densities, and both are rapidly spread via travellers.3 The difference between the two diseases is the mode of transmission. The four dengue virus serotypes are transmitted by Aedes spp mosquitoes, which mainly proliferate in the climatic conditions of the tropics and subtropics,4 whereas severe acute respiratory syndrome coronavirus 2 is transmitted via respiratory droplets ubiquitously. While the scientific community is racing towards developing a vaccine against COVID-19, we already have a vaccine at hand against dengue. First licensed in 2015, the tetravalent live attenuated dengue vaccine developed by Sanofi Pasteur (CYD-TDV, with the trade name of Dengvaxia) was evaluated in more than 30 000 children in ten countries in Asia and Latin America, with now more than 5 years of observation time since administration of the first dose.5 The combined phase 3 trials showed a moderate–high efficacy, with increasing efficacy with age, serotype 4, and in settings with higher seroprevalence. Further post-hoc analyses with retrospective stratification into baseline serostatus (presence or absence of previous dengue infection at the time of administration of the first dose) revealed that vaccine performance was strongly driven by serostatus: seropositive individuals benefitted from high efficacy, whereas seronegative individuals experienced no statistically significant efficacy but an increase in hospitalised dengue from year 3 onwards after administration of the first dose.5 Subsequently, WHO recommended that CYD-TDV should only be given to seropositive individuals. Hence screening for dengue serostatus before vaccination is needed.6 In The Lancet Infectious Diseases, Carlos DiazGranados and colleagues evaluated five commercially available immunoassays—two IgG-based ELISAs (EUROIMMUN and Panbio) and three rapid diagnostic tests (RDTs; TELL ME FAST, SD BIOLINE, and OnSite)—for their potential to classify baseline dengue serostatus, using baseline samples from more than 3000 participants in the immunogenicity subsets of the phase 3 CYD14 and CYD15 efficacy trials.7 All immunoassays exhibited high specificity (>98% for all immunoassays apart from SD BIOLINE RDT), but variable sensitivities, with higher sensitivities observed for the ELISAs (EUROIMMUN 89·2% [95% CI 87·9–90·3] and Panbio 92·5 [91·4 to 93·5]) than the RDTs (TELL ME FAST 52·5% [50·6 to 54·4], SD BIOLINE 71·1% [69·3 to 72·8], and OnSite 47·6% [45·7 to 49·5]).7 These results are encouraging, and consistent with an earlier evaluation of various ELISA against RDTs, in which sensitivities for RDTs were found to generally be lower than those of the ELISAs (≥90%).8, 9 Those studies also found that sensitivity for the assays evaluated by DiazGranados and colleagues appeared similar in samples from individuals with recent (<13 months) versus remote (3–4 years) virologically confirmed dengue.8 Additionally, cross-reactivity to other flaviviruses was low with RDTs (≤7%), but more significant with ELISAs (up to 51% for West Nile and 34% for Zika).8 DiazGranados and colleagues also re-evaluated CYD-TDV vaccine efficacy in participants identified as dengue seropositive by the five immunoassays.7 Vaccine efficacy against symptomatic virologically confirmed dengue in immunoassay-positive participants was high across all five immunoassays (from 82·8% [95% CI 66·9–91·1] by SD BIOLINE RDT to 89·7% [64·6–97·0] by OnSite RDT), as was vaccine efficacy against hospitalised virologically confirmed dengue (from 72·8% [38·9–87·9] by EUROIMMUN ELISA to 92·4% [37·8–99·1] by TELL ME FAST RDT), underpinning the public health usefulness of the first licensed dengue vaccine. Vaccine efficacy against severe virologically confirmed dengue was similarly high, but lacked precision owing to very few severe virologically confirmed dengue cases over the follow-up. DiazGranados and colleagues' findings suggest that current commercially available immunoassays and RDTs could be used for pre-vaccination screening for CYD-TDV. Although a more sensitive or convenient test would improve the performance and efficiency of pre-vaccination screening programmes, countries can start to choose from existing screening tests for their vaccination programmes. The key considerations for selection are accuracy, ease of use, and affordability. Ideally, a screening test should be both highly sensitive and specific to minimise false positives and negatives to yield maximal population level benefit and minimise harm by correctly screening for seropositive individuals only.6 It should also be affordable, simple to
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