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Long-term safety assessment of live attenuated tetravalent dengue vaccines: deliberations from a WHO technical consultation
- Source :
- Vaccine
- Publication Year :
- 2013
-
Abstract
- Dengue is a rapidly growing public health threat with approximately 2.5billion 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.
- Subjects :
- Male
Vaccine safety
medicine.medical_specialty
DENV, dengue virus
MEDLINE
Dengue Vaccines
Dengue vaccine
Vaccines, Attenuated
World Health Organization
Article
WHO, World Health Organization
Dengue fever
Scientific evidence
Post-licensure monitoring
Dengue
Clinical Trials, Phase II as Topic
Immunology and Microbiology(all)
medicine
Product Surveillance, Postmarketing
Humans
Intensive care medicine
SAE, serious adverse event
General Veterinary
General Immunology and Microbiology
Clinical Trials, Phase I as Topic
business.industry
LATDV, live attenuated tetravalent dengue vaccine
Public health
Public Health, Environmental and Occupational Health
ADE, antibody-dependent enhancement
Infant
Dengue Virus
medicine.disease
veterinary(all)
Clinical trial
Natural history
Vaccination
Infectious Diseases
PBMC, peripheral blood mononuclear cells
Child, Preschool
Immunology
Molecular Medicine
Female
Public Health
business
Subjects
Details
- Language :
- English
- ISSN :
- 18732518 and 0264410X
- Volume :
- 31
- Issue :
- 23
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....63be717e63ed3954a0c86b4f9559e1a2