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Long-term safety assessment of live attenuated tetravalent dengue vaccines: Deliberations from a WHO technical consultation

Abstract Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of... Full description

Journal Title: Vaccine 2013, Vol.31 (23), p.2603-2609
Main Author: Bentsi-Enchill, Adwoa D
Other Authors: Schmitz, Julia , Edelman, Robert , Durbin, Anna , Roehrig, John T , Smith, Peter G , Hombach, Joachim , Farrar, Jeremy
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0264-410X
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5355209
title: Long-term safety assessment of live attenuated tetravalent dengue vaccines: Deliberations from a WHO technical consultation
format: Article
creator:
  • Bentsi-Enchill, Adwoa D
  • Schmitz, Julia
  • Edelman, Robert
  • Durbin, Anna
  • Roehrig, John T
  • Smith, Peter G
  • Hombach, Joachim
  • Farrar, Jeremy
subjects:
  • ADE, antibody-dependent enhancement
  • Allergy and Immunology
  • Analysis
  • antibody
  • Applied microbiology
  • Arboviroses
  • Article
  • Biological and medical sciences
  • Child, Preschool
  • Clinical trials
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Dengue
  • Dengue - immunology
  • Dengue - prevention & control
  • Dengue fever
  • Dengue fevers
  • Dengue vaccine
  • Dengue Vaccines - administration & dosage
  • Dengue Vaccines - adverse effects
  • Dengue Vaccines - immunology
  • dengue virus
  • Dengue Virus - immunology
  • DENV, dengue virus
  • dependent enhancement
  • Environmental
  • Female
  • Fundamental and applied biological sciences. Psychology
  • Human viral diseases
  • Humans
  • Illnesses
  • Immunology
  • Infant
  • Infections
  • Infectious Diseases
  • LATDV, live attenuated tetravalent dengue vaccine
  • Licenses
  • licensure monitoring
  • live attenuated tetravalent dengue vaccine
  • Male
  • Medical sciences
  • Microbiology
  • Microbiology(all)
  • Molecular Medicine
  • Occupational Health
  • Pathogenesis
  • PBMC, peripheral blood mononuclear cells
  • peripheral blood mononuclear cells
  • Post
  • Post-licensure monitoring
  • Product Surveillance, Postmarketing
  • Public Health
  • SAE, serious adverse event
  • serious adverse event
  • Studies
  • Tropical diseases
  • Tropical viral diseases
  • Vaccination
  • Vaccine safety
  • Vaccines
  • Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
  • Vaccines, Attenuated - administration & dosage
  • Vaccines, Attenuated - adverse effects
  • Vaccines, Attenuated - immunology
  • veterinary(all)
  • Viral diseases
  • WHO, World Health Organization
  • World Health Organization
ispartof: Vaccine, 2013, Vol.31 (23), p.2603-2609
description: Abstract Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0264-410X
fulltext: fulltext
issn:
  • 0264-410X
  • 1873-2518
url: Link


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titleLong-term safety assessment of live attenuated tetravalent dengue vaccines: Deliberations from a WHO technical consultation
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creatorBentsi-Enchill, Adwoa D ; Schmitz, Julia ; Edelman, Robert ; Durbin, Anna ; Roehrig, John T ; Smith, Peter G ; Hombach, Joachim ; Farrar, Jeremy
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descriptionAbstract Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use.
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publisherKidlington: Elsevier Ltd
subjectADE, antibody-dependent enhancement ; Allergy and Immunology ; Analysis ; antibody ; Applied microbiology ; Arboviroses ; Article ; Biological and medical sciences ; Child, Preschool ; Clinical trials ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Dengue ; Dengue - immunology ; Dengue - prevention & control ; Dengue fever ; Dengue fevers ; Dengue vaccine ; Dengue Vaccines - administration & dosage ; Dengue Vaccines - adverse effects ; Dengue Vaccines - immunology ; dengue virus ; Dengue Virus - immunology ; DENV, dengue virus ; dependent enhancement ; Environmental ; Female ; Fundamental and applied biological sciences. Psychology ; Human viral diseases ; Humans ; Illnesses ; Immunology ; Infant ; Infections ; Infectious Diseases ; LATDV, live attenuated tetravalent dengue vaccine ; Licenses ; licensure monitoring ; live attenuated tetravalent dengue vaccine ; Male ; Medical sciences ; Microbiology ; Microbiology(all) ; Molecular Medicine ; Occupational Health ; Pathogenesis ; PBMC, peripheral blood mononuclear cells ; peripheral blood mononuclear cells ; Post ; Post-licensure monitoring ; Product Surveillance, Postmarketing ; Public Health ; SAE, serious adverse event ; serious adverse event ; Studies ; Tropical diseases ; Tropical viral diseases ; Vaccination ; Vaccine safety ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, Attenuated - administration & dosage ; Vaccines, Attenuated - adverse effects ; Vaccines, Attenuated - immunology ; veterinary(all) ; Viral diseases ; WHO, World Health Organization ; World Health Organization
ispartofVaccine, 2013, Vol.31 (23), p.2603-2609
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62013 World Health Organization 2013
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2Edelman, Robert
3Durbin, Anna
4Roehrig, John T
5Smith, Peter G
6Hombach, Joachim
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8Live Dengue Vaccines Technical Consultation Reporting Group
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0Long-term safety assessment of live attenuated tetravalent dengue vaccines: Deliberations from a WHO technical consultation
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descriptionAbstract Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use.
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0ADE, antibody-dependent enhancement
1Allergy and Immunology
2Analysis
3antibody
4Applied microbiology
5Arboviroses
6Article
7Biological and medical sciences
8Child, Preschool
9Clinical trials
10Clinical Trials, Phase I as Topic
11Clinical Trials, Phase II as Topic
12Dengue
13Dengue - immunology
14Dengue - prevention & control
15Dengue fever
16Dengue fevers
17Dengue vaccine
18Dengue Vaccines - administration & dosage
19Dengue Vaccines - adverse effects
20Dengue Vaccines - immunology
21dengue virus
22Dengue Virus - immunology
23DENV, dengue virus
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26Female
27Fundamental and applied biological sciences. Psychology
28Human viral diseases
29Humans
30Illnesses
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33Infections
34Infectious Diseases
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36Licenses
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38live attenuated tetravalent dengue vaccine
39Male
40Medical sciences
41Microbiology
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43Molecular Medicine
44Occupational Health
45Pathogenesis
46PBMC, peripheral blood mononuclear cells
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48Post
49Post-licensure monitoring
50Product Surveillance, Postmarketing
51Public Health
52SAE, serious adverse event
53serious adverse event
54Studies
55Tropical diseases
56Tropical viral diseases
57Vaccination
58Vaccine safety
59Vaccines
60Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
61Vaccines, Attenuated - administration & dosage
62Vaccines, Attenuated - adverse effects
63Vaccines, Attenuated - immunology
64veterinary(all)
65Viral diseases
66WHO, World Health Organization
67World Health Organization
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titleLong-term safety assessment of live attenuated tetravalent dengue vaccines: Deliberations from a WHO technical consultation
authorBentsi-Enchill, Adwoa D ; Schmitz, Julia ; Edelman, Robert ; Durbin, Anna ; Roehrig, John T ; Smith, Peter G ; Hombach, Joachim ; Farrar, Jeremy
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9Clinical trials
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15Dengue fever
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19Dengue Vaccines - adverse effects
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36Licenses
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39Male
40Medical sciences
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42Microbiology(all)
43Molecular Medicine
44Occupational Health
45Pathogenesis
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50Product Surveillance, Postmarketing
51Public Health
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57Vaccination
58Vaccine safety
59Vaccines
60Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
61Vaccines, Attenuated - administration & dosage
62Vaccines, Attenuated - adverse effects
63Vaccines, Attenuated - immunology
64veterinary(all)
65Viral diseases
66WHO, World Health Organization
67World Health Organization
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abstractAbstract Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use.
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