PMID- 24189367
OWN - NLM
STAT- MEDLINE
DCOM- 20140226
LR  - 20211021
IS  - 1476-1645 (Electronic)
IS  - 0002-9637 (Print)
IS  - 0002-9637 (Linking)
VI  - 89
IP  - 6
DP  - 2013 Dec
TI  - Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children 
      and adolescents ages 9-16 years in Brazil.
PG  - 1058-1065
LID - 10.4269/ajtmh.13-0304 [doi]
AB  - Immunogenicity and safety of a recombinant, live-attenuated, tetravalent dengue 
      disease vaccine (CYD-TDV) was evaluated in children/adolescents in Brazil. In 
      this observer-blind, placebo-controlled, phase II single-center study, 
      children/adolescents (ages 9-16 years) were randomized to receive CYD-TDV or 
      placebo at 0, 6, and 12 months. Immunogenicity was assessed using a 50% plaque 
      neutralization test. Overall, 150 participants were enrolled (CYD-TDV: N = 100; 
      placebo: N = 50). Injection site pain and headache were the most common solicited 
      injection site and systemic reactions. Unsolicited adverse events (AEs) and 
      serious AEs were similar between groups. No serious AEs were vaccine-related. 
      Geometric mean titers against all dengue virus serotypes increased with CYD-TDV 
      vaccination and were 267, 544, 741, and 432 1/dil for serotypes 1-4, 
      respectively, after dose 3, representing a mean fold increase from baseline of 5, 
      6, 6, and 20, respectively. CYD-TDV vaccination elicited a neutralizing antibody 
      response against serotypes 1-4 and was well-tolerated in children/adolescents in 
      a dengue-endemic region.
FAU - Dayan, Gustavo H
AU  - Dayan GH
FAU - Garbes, Pedro
AU  - Garbes P
FAU - Noriega, Fernando
AU  - Noriega F
FAU - Izoton de Sadovsky, Ana Daniela
AU  - Izoton de Sadovsky AD
FAU - Rodrigues, Patricia Marques
AU  - Rodrigues PM
FAU - Giuberti, Camila
AU  - Giuberti C
FAU - Dietze, Reynaldo
AU  - Dietze R
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131104
PL  - United States
TA  - Am J Trop Med Hyg
JT  - The American journal of tropical medicine and hygiene
JID - 0370507
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Dengue Vaccines)
RN  - 0 (Vaccines, Synthetic)
SB  - IM
MH  - Adolescent
MH  - Antibodies, Neutralizing/blood
MH  - Antibodies, Viral/*blood
MH  - Brazil
MH  - Child
MH  - Cohort Studies
MH  - Dengue/immunology/*prevention & control
MH  - Dengue Vaccines/administration & dosage/adverse effects/*immunology
MH  - Dengue Virus/*immunology
MH  - Female
MH  - Headache
MH  - Humans
MH  - Injections, Subcutaneous/adverse effects
MH  - Male
MH  - Single-Blind Method
MH  - Vaccination
MH  - Vaccines, Synthetic/administration & dosage/adverse effects/immunology
PMC - PMC3854882
EDAT- 2013/11/06 06:00
MHDA- 2014/02/27 06:00
PMCR- 2013/12/04
CRDT- 2013/11/06 06:00
PHST- 2013/11/06 06:00 [entrez]
PHST- 2013/11/06 06:00 [pubmed]
PHST- 2014/02/27 06:00 [medline]
PHST- 2013/12/04 00:00 [pmc-release]
AID - 10.4269/ajtmh.13-0304 [doi]
PST - ppublish
SO  - Am J Trop Med Hyg. 2013 Dec;89(6):1058-1065. doi: 10.4269/ajtmh.13-0304. Epub 
      2013 Nov 4.