For Publishers
DiscoveryMetadataPeer reviewHostingPublishing
For Researchers
JoinPublishReviewCollect
Register
Blog
About
Search
Advanced search
My ScienceOpen
Search
For Publishers
For Researchers
Blog
About
114
views
8
references
 Top references
cited by
412
    
0 reviews
 Review
0
comments
 Comment
0
recommends
+1 Recommend
0 collections
    0
    shares
      22
      similar
       All similar
      • Record: found
      • Abstract: found
      • Article: not found

      Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease.

      Read this article at

      ScienceOpenPublisherPubMed
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses.

          Related collections

          Most cited references8

          • Record: found
          • Abstract: found
          • Article: not found

          The epidemiology of dengue in the americas over the last three decades: a worrisome reality.

          José San Martín, Olivia Brathwaite, Betzana Zambrano … (2010)
          We have reported the epidemic patterns of dengue disease in the Region of the Americas from 1980 through 2007. Dengue cases reported to the Pan American Health Organization were analyzed from three periods: 1980-1989 (80s), 1990-1999 (90s), and 2000-2007 (2000-7). Age distribution data were examined from Brazil, Venezuela, Honduras, and Mexico. Cases increased over time: 1,033,417 (80s) to 2,725,405 (90s) to 4,759,007 (2000-7). The highest concentrations were reported in the Hispanic Caribbean (39.1%) in the 80s shifting to the Southern Cone in the 90s (55%) and 2000-7 (62.9%). From 1980 through 1987, 242 deaths were reported compared with 1,391 during 2000-7. The most frequently isolated serotypes were DENV-1 and DENV-2 (90s) and DENV-2 and DENV-3 (2000-7). The highest incidence was observed among adolescents and young adults; dengue hemorrhagic fever incidence was highest among infants in Venezuela. Increasing dengue morbidity/mortality was observed in the Americas in recent decades.
          Article 0 comments Cited 184 times – based on 0 reviews     Review now
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Efficacy of a tetravalent dengue vaccine in children in Latin America.

            Luis A Villar, Gustavo Horacio Dayan, José Arredondo-García … (2015)
            In light of the increasing rate of dengue infections throughout the world despite vector-control measures, several dengue vaccine candidates are in development. In a phase 3 efficacy trial of a tetravalent dengue vaccine in five Latin American countries where dengue is endemic, we randomly assigned healthy children between the ages of 9 and 16 years in a 2:1 ratio to receive three injections of recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) or placebo at months 0, 6, and 12 under blinded conditions. The children were then followed for 25 months. The primary outcome was vaccine efficacy against symptomatic, virologically confirmed dengue (VCD), regardless of disease severity or serotype, occurring more than 28 days after the third injection. A total of 20,869 healthy children received either vaccine or placebo. At baseline, 79.4% of an immunogenicity subgroup of 1944 children had seropositive status for one or more dengue serotypes. In the per-protocol population, there were 176 VCD cases (with 11,793 person-years at risk) in the vaccine group and 221 VCD cases (with 5809 person-years at risk) in the control group, for a vaccine efficacy of 60.8% (95% confidence interval [CI], 52.0 to 68.0). In the intention-to-treat population (those who received at least one injection), vaccine efficacy was 64.7% (95% CI, 58.7 to 69.8). Serotype-specific vaccine efficacy was 50.3% for serotype 1, 42.3% for serotype 2, 74.0% for serotype 3, and 77.7% for serotype 4. Among the severe VCD cases, 1 of 12 was in the vaccine group, for an intention-to-treat vaccine efficacy of 95.5%. Vaccine efficacy against hospitalization for dengue was 80.3%. The safety profile for the CYD-TDV vaccine was similar to that for placebo, with no marked difference in rates of adverse events. The CYD-TDV dengue vaccine was efficacious against VCD and severe VCD and led to fewer hospitalizations for VCD in five Latin American countries where dengue is endemic. (Funded by Sanofi Pasteur; ClinicalTrials.gov number, NCT01374516.).
            Article 0 comments Cited 122 times – based on 0 reviews     Review now
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.

              Maria Capeding, Ngoc Huu Tran, Sri Hadinegoro … (2014)
              An estimated 100 million people have symptomatic dengue infection every year. This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed dengue in children. We did an observer-masked, randomised controlled, multicentre, phase 3 trial in five countries in the Asia-Pacific region. Between June 3, and Dec 1, 2011, healthy children aged 2-14 years were randomly assigned (2:1), by computer-generated permuted blocks of six with an interactive voice or web response system, to receive three injections of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV), or placebo, at months 0, 6, and 12. Randomisation was stratified by age and site. Participants were followed up until month 25. Trial staff responsible for the preparation and administration of injections were unmasked to group allocation, but were not included in the follow-up of the participants; allocation was concealed from the study sponsor, investigators, and parents and guardians. Our primary objective was to assess protective efficacy against symptomatic, virologically confirmed dengue, irrespective of disease severity or serotype, that took place more than 28 days after the third injection. The primary endpoint was for the lower bound of the 95% CI of vaccine efficacy to be greater than 25%. Analysis was by intention to treat and per procotol. This trial is registered with ClinicalTrials.gov, number NCT01373281. We randomly assigned 10,275 children to receive either vaccine (n=6851) or placebo (n=3424), of whom 6710 (98%) and 3350 (98%), respectively, were included in the primary analysis. 250 cases of virologically confirmed dengue took place more than 28 days after the third injection (117 [47%] in the vaccine group and 133 [53%] in the control group). The primary endpoint was achieved with 56·5% (95% CI 43·8-66·4) efficacy. We recorded 647 serious adverse events (402 [62%] in the vaccine group and 245 [38%] in the control group). 54 (1%) children in the vaccine group and 33 (1%) of those in the control group had serious adverse events that happened within 28 days of vaccination. Serious adverse events were consistent with medical disorders in this age group and were mainly infections and injuries. Our findings show that dengue vaccine is efficacious when given as three injections at months 0, 6, and 12 to children aged 2-14 years in endemic areas in Asia, and has a good safety profile. Vaccination could reduce the incidence of symptomatic infection and hospital admission and has the potential to provide an important public health benefit. Sanofi Pasteur. Copyright © 2014 Elsevier Ltd. All rights reserved.
              Article 0 comments Cited 102 times – based on 0 reviews     Review now
                Bookmark
                All references

                Author and article information

                Journal
                Journal ID (iso-abbrev): N. Engl. J. Med.
                Title: The New England journal of medicine
                ISSN (Electronic): 1533-4406
                ISSN (Print): 0028-4793
                Publication date (Electronic): Sep 24 2015
                Volume: 373
                Issue: 13
                Affiliations
                [1 ] From Cipto Mangunkusumo Hospital, University of Indonesia, Jakarta (S.R.H.); Instituto Nacional de Pediatria, Mexico City (J.L.A.-G.); Research Institute for Tropical Medicine, Muntinlupa City, the Philippines (M.R.C.); Caribbean Travel Medicine Clinic, San Juan, Puerto Rico (C.D.); Queen Sirikit National Institute of Child Health (T.C.), Faculty of Tropical Medicine, Mahidol University (K.L.), and Sanofi Pasteur (D.C.) - all in Bangkok, Thailand; Nucleo de Doencas Infecciosas, Universidade Federal do Espirito Santo, Vitoria, ES, Brazil (R.D.); Hospital Kuala Lumpur, Kuala Lumpur, Malaysia (H.I.H.M.I.); Centro de Atencion e Investigacion Medica SAS-CAIMED (H.R.), and Sanofi Pasteur (M.C.) - both in Bogota, Colombia; Organizacion para el Desarrollo y la Investigacion Salud en Honduras (ODIS), Tegucigalpa (D.M.R.-M.); Pasteur Institute in Ho Chi Minh City, Ho Chi Minh City, Vietnam (H.N.T.); Sanofi Pasteur, Singapore, Singapore (A.B., C.F., T.A.W.); Sanofi R&D, Chilly-Mazarin (K.F.), Marcy l'Etoile (R.F., E.P.), and Lyon (S.G., N.J., M.S.) - all in France; Sanofi Pasteur, Swiftwater, PA (F.N.); and Sanofi Pasteur, Montevideo, Uruguay (B.Z.).
                Article
                DOI: 10.1056/NEJMoa1506223
                PubMed ID: 26214039
                SO-VID: c9b24d33-6f3d-40a1-b596-41ce5fb67207
                History

                Data availability:

                Comments

                Comment on this article

                scite_

                Similar content22

                See all similar

                Cited by388

                See all cited by

                Most referenced authors216

                See all reference authors