Publication: Detection of dengue cases by serological testing in a dengue vaccine efficacy trial: Utility for efficacy evaluation and impact of future vaccine introduction
Issued Date
2016-05-23
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ISSN
18732518
0264410X
0264410X
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2-s2.0-84963936272
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Mahidol University
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SCOPUS
Bibliographic Citation
Vaccine. Vol.34, No.24 (2016), 2707-2712
Suggested Citation
Eric Plennevaux, Arunee Sabchareon, Kriengsak Limkittikul, Pornthep Chanthavanich, Chukiat Sirivichayakul, Annick Moureau, Mark Boaz, T. Anh Wartel, Melanie Saville, Alain Bouckenooghe Detection of dengue cases by serological testing in a dengue vaccine efficacy trial: Utility for efficacy evaluation and impact of future vaccine introduction. Vaccine. Vol.34, No.24 (2016), 2707-2712. doi:10.1016/j.vaccine.2016.04.028 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/43098
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Title
Detection of dengue cases by serological testing in a dengue vaccine efficacy trial: Utility for efficacy evaluation and impact of future vaccine introduction
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Abstract
© 2016 Elsevier Ltd. Background: Dengue diagnosis confirmation and surveillance are widely based on serological assays to detect anti-dengue IgM or IgG antibodies since such tests are affordable/user-friendly. The World Health Organization identified serological based diagnosis as a potential tool to define probable dengue cases in the context of vaccine trials, while acknowledging that this may have to be interpreted with caution. Methods: In a phase IIb randomized, placebo-controlled trial assessing the efficacy of a tetravalent dengue vaccine (CYD-TDV) in Thai schoolchildren, case definition was based on virological confirmation by either serotype-specific RT-PCRs or by NS1-antigen ELISA (Clinicaltrials.gov NCT00842530). Here, we characterized suspected dengue cases using IgM and IgG ELISA to assess their utility in evaluating probable dengue cases in the context of vaccine efficacy trials, comparing virologically-confirmed and serologically diagnosed dengue in the vaccine and placebo groups. Serologically probable cases were defined as: (1) IgM positive acute- or convalescent-phase samples, or (2) IgG positive acute-phase sample and ≥4-fold IgG increase between acute and convalescent-phase samples. Results: Serological diagnosis had good sensitivity (97.1%), but low specificity (85.1%) compared to virological confirmation. A high level of false positivity through serology diagnosis particularly in the 2 months post-vaccination was observed, and is most likely related to detection of the immune response to the dengue vaccine. This lack of specificity and bias with vaccination demonstrates the limitation of using IgM and IgG antibody responses to explore vaccine efficacy. Conclusion: Reliance on serological assessments would lead to a significant number of false positives during routine clinical practice and surveillance following the introduction of the dengue vaccine.