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Forrat R., Dayan G.H., DiazGranados C.A., Bonaparte M., Laot T., Capeding M.R., Sanchez L., Coronel D.L., Reynales H., Chansinghakul D., Hadinegoro S.R.S., Perroud A.P., Frago C., Zambrano B., Machabert T., Wu Y., Luedtke A., Price B., Vigne C., Haney O., Savarino S.J., Bouckenooghe A., Noriega F. |
36339272700;6701860993;56721307400;56614799700;24471016000;6602161242;57201082261;56418742600;55343075300;29067671300;56893685800;57198777256;56255310300;7801355579;57201364463;57215829074;54395741500;57002517700;57192890936;57215866119;57220410062;18233281300;7005980306; |
Analysis of Hospitalized and Severe Dengue Cases Over the 6 years of Follow-up of the Tetravalent Dengue Vaccine (CYD-TDV) Efficacy Trials in Asia and Latin America |
2021 |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America |
73 |
6 |
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1003 |
1012 |
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https://www.scopus.com/inward/record.uri?eid=2-s2.0-85116958578&doi=10.1093%2fcid%2fciab288&partnerID=40&md5=cceec1a946e6b236b138dcb4bb663855 |
Clinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France; Clinical Sciences Sanofi PasteurPA, United States; Translation Sciences and Biomarkers, Sanofi PasteurPA, United States; Global Clinical Science, Sanofi Pasteur, Taguig City, Philippines; Research Institute for Tropical Medicine, Medical Department, Muntinlupa, Philippines; Clinical Sciences, Sanofi PasteurMexico City, Mexico; Centro de Atencion e Investigación Médica, Bogotá, Colombia; Research & Development, Sanofi PasteurBangkok, Thailand; Cipto Mangunkusumo Hospital, University of IndonesiaJakarta, Indonesia; Clinical Sciences, Sanofi Pasteur, São Paulo, Brazil; Clinical Sciences, Sanofi Pasteur, Singapore; Clinical Sciences, Sanofi Pasteur, Uruguay; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States; Global Pharmacovigilance, Sanofi PasteurPA, United States |
Forrat, R., Clinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France; Dayan, G.H., Clinical Sciences Sanofi PasteurPA, United States; DiazGranados, C.A., Clinical Sciences Sanofi PasteurPA, United States; Bonaparte, M., Translation Sciences and Biomarkers, Sanofi PasteurPA, United States; Laot, T., Global Clinical Science, Sanofi Pasteur, Taguig City, Philippines; Capeding, M.R., Research Institute for Tropical Medicine, Medical Department, Muntinlupa, Philippines; Sanchez, L., Global Clinical Science, Sanofi Pasteur, Taguig City, Philippines; Coronel, D.L., Clinical Sciences, Sanofi PasteurMexico City, Mexico; Reynales, H., Centro de Atencion e Investigación Médica, Bogotá, Colombia; Chansinghakul, D., Research & Development, Sanofi PasteurBangkok, Thailand; Hadinegoro, S.R.S., Cipto Mangunkusumo Hospital, University of IndonesiaJakarta, Indonesia; Perroud, A.P., Clinical Sciences, Sanofi Pasteur, São Paulo, Brazil; Frago, C., Clinical Sciences, Sanofi Pasteur, Singapore; Zambrano, B., Clinical Sciences, Sanofi Pasteur, Uruguay; Machabert, T., Clinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France; Wu, Y., Clinical Sciences Sanofi PasteurPA, United States; Luedtke, A., Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States; Price, B., Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States; Vigne, C., Clinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France; Haney, O., Global Pharmacovigilance, Sanofi PasteurPA, United States; Savarino, S.J., Translation Sciences and Biomarkers, Sanofi PasteurPA, United States; Bouckenooghe, A., Clinical Sciences, Sanofi Pasteur, São Paulo, Brazil; Noriega, F., Clinical Sciences Sanofi PasteurPA, United States |
BACKGROUND: CYD-TDV, a live, attenuated, tetravalent dengue vaccine, has been approved for the prevention of symptomatic dengue in previously dengue exposed individuals. This post hoc analysis assessed hospitalized and severe virologically confirmed dengue (VCD) over the complete 6-year follow-up of 3 CYD-TDV efficacy studies (CYD14, CYD15, and CYD23/CYD57). METHODS: The main outcomes were hazard ratios (HRs) for hospitalized or severe VCD by baseline dengue serostatus, focusing on those who were seropositive, and by age at immunization (<9 years/≥9 years). Baseline dengue serostatus was measured or inferred using several methods. Hospitalized VCD cases were characterized in terms of clinical signs and symptoms and wild-type viremia level. Antibody persistence was assessed up to 5 years after the last injection. RESULTS: In those aged ≥9 years and baseline seropositive, CYD-TDV protected against hospitalized and severe VCD over 6 years compared to placebo (HR [95% confidence interval] multiple imputation from month 0 method, .19 [.12-.30] and .15 [.06-.39]; other methods were consistent). Vaccine protection was observed over the different study periods, being highest during the first 2 years. Evidence for a decreased risk of hospitalized and severe VCD was also observed in seropositive participants aged 6-8 years. Clinical signs and symptoms, and quantified dengue viremia from participants with hospitalized VCD were comparable between groups. CONCLUSIONS: CYD-TDV demonstrated robust protection against hospitalized and severe VCD over the entire 6-year follow-up in participants who were seropositive and ≥9 years old. Protection was also observed in seropositive 6-8 year-olds. Clinical Trials Registration: NCT00842530, NCT01983553, NCT01373281, NCT01374516. © The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. |
CYD-TDV; dengue; serostatus; VCD |
dengue vaccine; live vaccine; vaccine; virus antibody; Asia; child; controlled study; dengue; Dengue virus; follow up; human; randomized controlled trial; severe dengue; South and Central America; Antibodies, Viral; Asia; Child; Dengue; Dengue Vaccines; Dengue Virus; Follow-Up Studies; Humans; Latin America; Severe Dengue; Vaccines, Attenuated; Vaccines, Combined |
NLM (Medline) |
15376591 |
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33822015 |
Article |
Q1 |
3440 |
518 |
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