Browsing by Author "Danaya Chansinghakul"

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    Impact of Dengue Vaccination on Serological Diagnosis: Insights from Phase III Dengue Vaccine Efficacy Trials
    (2018-04-03) Eric Plennevaux; Annick Moureau; José L. Arredondo-García; Luis Villar; Punnee Pitisuttithum; Ngoc H. Tran; Matthew Bonaparte; Danaya Chansinghakul; Diana L. Coronel; Maïna L'Azou; R. Leon Ochiai; Myew Ling Toh; Fernando Noriega; Alain Bouckenooghe; Pasteur Institute in Ho Chi Minh City; Sanofi Pasteur SA; Universidad Industrial de Santander; Mahidol University; Instituto Nacional de Pediatría; Clinical Sciences; Global Epidemiology; Sanofi Pasteur; Clinical Sciences; Sanofi Pasteur
    © 2017 The Author(s). Published by Oxford University Press for the Infectious Diseases Society of America. Background We previously reported that vaccination with the tetravalent dengue vaccine (CYD-TDV; Dengvaxia) may bias the diagnosis of dengue based on immunoglobulin M (IgM) and immunoglobulin G (IgG) assessments. Methods We undertook a post hoc pooled analysis of febrile episodes that occurred during the active surveillance phase (the 25 months after the first study injection) of 2 pivotal phase III, placebo-controlled CYD-TDV efficacy studies that involved ≥31000 children aged 2-16 years across 10 countries in Asia and Latin America. Virologically confirmed dengue (VCD) episode was defined with a positive test for dengue nonstructural protein 1 antigen or dengue polymerase chain reaction. Probable dengue episode was serologically defined as (1) IgM-positive acute- or convalescent-phase sample, or (2) IgG-positive acute-phase sample and ≥4-fold IgG increase between acute- and convalescent-phase samples. Results There were 1284 VCD episodes (575 and 709 in the CYD-TDV and placebo groups, respectively) and 17673 other febrile episodes (11668 and 6005, respectively). Compared with VCD, the sensitivity and specificity of probable dengue definition were 93.1% and 77.2%, respectively. Overall positive and negative predictive values were 22.9% and 99.5%, respectively, reflecting the much lower probability of correctly confirming probable dengue in a population including a vaccinated cohort. Vaccination-induced bias toward false-positive diagnosis was more pronounced among individuals seronegative at baseline. Conclusions Caution will be required when interpreting IgM and IgG data obtained during routine surveillance in those vaccinated with CYD-TDV. There is an urgent need for new practical, dengue-specific diagnostic algorithms now that CYD-TDV is approved in a number of dengue-endemic countries.
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    Long-term safety follow-up of children from a randomized - Controlled phase II b proof - Of - concept efficacy study of the live, attenuated, tetravalent dengue vaccine (CYD - TDV) in Thailand
    (2019-09-01) Kriengsak Limkittikul; Weerawan Hattasingh; Danaya Chansinghakul; Arunee Sabchareon; Wut Dulyachai; Carina Frago; T. Anh Wartel; Edith Langevin; Sophia Gailhardou; Alain Bouckenooghe; Sanofi Pasteur SA; Mahidol University; Ratchaburi Regional Hospital; Sanofi Pasteur; Sanofi Pasteur
    © 2019 Wolters Kluwer Medknow Publications. All rights reserved. Objective: To investigate the long-term safety of a tetravalent dengue vaccine (CYD-TDV) in children in a phase Π b follow-up study in Thailand. Methods: In the phase Π b study, children aged 4-11 years were randomized (2:1) to receive three injections of CYD-TDV or serve as control at 6-month intervals, with 25 months' active follow-up (active phase). This study was an additional four-year passive surveillance for hospitalized virologically-confirmed dengue (VCD; hospital phase). Cases of hospitalized VCD, severe hospitalized VCD, vaccine-related serious adverse events, and deaths were reported for the total population, with post-hoc analyses by enrollment age (<9 and years). Results: Of 3 997 participants receiving injection, 80.1% were recruited to the hospital phase [2 131 (CYD-TDV); 1 072 (control)]. Eighty-five hospitalized VCD cases were reported in the CYD-TDV group and 46 in the control group during the four-year hospital phase [relative risk (RR): 0.93, 95% confidence interval (CI): 0.64-1.36]. The RR over six years of follow-up was 0.77 (95% CI: 0.57-1.05). In those aged ≥9 years, the cumulative RRs in the active phase, hospital phase, and entire six years were 0.28 (95% CI: 0.08-0.81), 0.51 (95% CI: 0.25-1.05), and 0.42 (95% CI: 0.24-0.75), respectively. In the overall population, there were ten severe hospitalized VCD cases in the CYD-TDV group and five in the control group over six years (RR: 1.00, 95% CI: 0.31-3.75). Conclusions: Over six years of follow-up, in children aged ≥9 years, CYD-TDV administration is associated with a reduced risk of hospitalized VCD.
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    Serological Evidence of Japanese Encephalitis Virus Circulation in Asian Children From Dengue-Endemic Countries
    (2019-01-09) Joshua Nealon; Anne Frieda Taurel; Sutee Yoksan; Annick Moureau; Matt Bonaparte; Luong Chan Quang; Maria R. Capeding; Ari Prayitno; Sri Rezeki Hadinegoro; Danaya Chansinghakul; Alain Bouckenooghe; Pasteur Institute in Ho Chi Minh City; Gokila; Universitas Indonesia; Sanofi Pasteur SA; Mahidol University; Sanofi Pasteur; Sanofi Pasteur; Sanofi Pasteur
    © 2018 The Author(s). Background. Japanese encephalitis virus (JEV) is a zoonotic, mosquito-borne flavivirus, distributed across Asia. Infections are mostly mild or asymptomatic, but symptoms include neurological disorders, sequelae, and fatalities. Data to inform control strategies are limited due to incomplete case reporting. Methods. We used JEV serological data from a multicountry Asian dengue vaccine study in children aged 2-14 years to describe JEV endemicity, measuring antibodies by plaque reduction neutralization test (PRNT50). Results. A total 1479 unvaccinated subjects were included. A minimal estimate of pediatric JEV seroprevalence in dengue-naive individuals was 8.1% in Indonesia, 5.8% in Malaysia, 10.8% in the Philippines, and 30.7% in Vietnam, translating to annual infection risks varying from 0.8% (in Malaysia) to 5.2% (in Vietnam). JEV seroprevalence and annual infection estimates were much higher in children with history of dengue infection, indicating cross-neutralization within the JEV PRNT50 assay. Conclusions. These data confirm JEV transmission across predominantly urban areas and support a greater emphasis on JEV case finding, diagnosis, and prevention.