A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico
| العنوان: | A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico |
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| المؤلفون: | Stefan Fernandez, Bruce L. Innis, Rafael De La Barrera, Kristen M. Bauer, Stephen J. Thomas, Simon Carlo, Ana I. Quintero del Rio, Clemente Diaz, Jorge Bertran-Pasarell, Jean-François Toussaint, Wellington Sun, Ines O. Esquilin, Alberto S. Cornier, Elodie Tournay, Arthur Lyons, Kenneth H. Eckels, Javier O. Morales Ramirez |
| المصدر: | The American Journal of Tropical Medicine and Hygiene |
| بيانات النشر: | American Society of Tropical Medicine and Hygiene, 2015. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Adolescent, Dengue Vaccines, Dengue virus, Antibodies, Viral, Vaccines, Attenuated, Placebo, medicine.disease_cause, law.invention, Dengue fever, Dengue, Young Adult, Double-Blind Method, Randomized controlled trial, law, Virology, Internal medicine, Humans, Medicine, Child, Adverse effect, Dengue vaccine, business.industry, Immunogenicity, Puerto Rico, Antibody titer, Infant, Articles, Dengue Virus, Middle Aged, medicine.disease, Antibodies, Neutralizing, Infectious Diseases, Child, Preschool, Immunology, Female, Parasitology, business |
| الوصف: | This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1–50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2–4 years], 60% [5–20 years], and 93% [21–50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858. |
| تدمد: | 1476-1645 0002-9637 |
| DOI: | 10.4269/ajtmh.14-0625 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c557a2cc6080f01043b9a1eb969eac90 https://doi.org/10.4269/ajtmh.14-0625 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....c557a2cc6080f01043b9a1eb969eac90 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14761645 00029637 |
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| DOI: | 10.4269/ajtmh.14-0625 |