PMID- 21813857
OWN - NLM
STAT- MEDLINE
DCOM- 20111004
LR  - 20211020
IS  - 1476-1645 (Electronic)
IS  - 0002-9637 (Print)
IS  - 0002-9637 (Linking)
VI  - 85
IP  - 2
DP  - 2011 Aug
TI  - Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in 
      flavivirus-naive infants.
PG  - 341-51
LID - 10.4269/ajtmh.2011.10-0501 [doi]
AB  - A Phase I/II observer-blind, randomized, controlled trial evaluated the safety 
      and immunogenicity of a dengue virus (DENV) vaccine candidate in healthy Thai 
      infants (aged 12-15 months) without measurable pre-vaccination neutralizing 
      antibodies to DENV and Japanese encephalitis virus. Fifty-one subjects received 
      two doses of either DENV (N = 34; four received 1/10th dose) or control vaccine 
      (N = 17; dose 1, live varicella; dose 2, Haemophilus influenzae type b). After 
      each vaccine dose, adverse events (AEs) were solicited for 21 days, and 
      non-serious AEs were solicited for 30 days; serious AEs (SAEs) were recorded 
      throughout the study. Laboratory safety assessments were performed at 10 and 30 
      days; neutralizing antibodies were measured at 30 days. The DENV vaccine was 
      well-tolerated without any related SAEs. After the second dose, 85.7% of 
      full-dose DENV vaccinees developed at least trivalent and 53.6% developed 
      tetravalent neutralizing antibodies >/= 1:10 to DENV (control group = 0%). This 
      vaccine candidate, therefore, warrants continued development in this age group 
      (NCT00322049; clinicaltrials.gov).
FAU - Watanaveeradej, Veerachai
AU  - Watanaveeradej V
AD  - Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand. 
      veerachaiw@yahoo.com
FAU - Simasathien, Sriluck
AU  - Simasathien S
FAU - Nisalak, Ananda
AU  - Nisalak A
FAU - Endy, Timothy P
AU  - Endy TP
FAU - Jarman, Richard G
AU  - Jarman RG
FAU - Innis, Bruce L
AU  - Innis BL
FAU - Thomas, Stephen J
AU  - Thomas SJ
FAU - Gibbons, Robert V
AU  - Gibbons RV
FAU - Hengprasert, Sumetha
AU  - Hengprasert S
FAU - Samakoses, Rudiwilai
AU  - Samakoses R
FAU - Kerdpanich, Angkool
AU  - Kerdpanich A
FAU - Vaughn, David W
AU  - Vaughn DW
FAU - Putnak, J Robert
AU  - Putnak JR
FAU - Eckels, Kenneth H
AU  - Eckels KH
FAU - Barrera, Rafael De La
AU  - Barrera Rde L
FAU - Mammen, Mammen P Jr
AU  - Mammen MP Jr
LA  - eng
SI  - ClinicalTrials.gov/NCT00322049
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PL  - United States
TA  - Am J Trop Med Hyg
JT  - The American journal of tropical medicine and hygiene
JID - 0370507
RN  - 0 (Dengue Vaccines)
RN  - 0 (Japanese Encephalitis Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Dengue/*prevention & control
MH  - Dengue Vaccines/administration & dosage/adverse effects/*immunology
MH  - Encephalitis, Japanese/prevention & control
MH  - Humans
MH  - Immunization Schedule
MH  - Infant
MH  - Japanese Encephalitis Vaccines/immunology
MH  - Vaccines, Attenuated/administration & dosage/adverse effects/immunology
PMC - PMC3144835
EDAT- 2011/08/05 06:00
MHDA- 2011/10/05 06:00
PMCR- 2012/08/01
CRDT- 2011/08/05 06:00
PHST- 2011/08/05 06:00 [entrez]
PHST- 2011/08/05 06:00 [pubmed]
PHST- 2011/10/05 06:00 [medline]
PHST- 2012/08/01 00:00 [pmc-release]
AID - 85/2/341 [pii]
AID - 10.4269/ajtmh.2011.10-0501 [doi]
PST - ppublish
SO  - Am J Trop Med Hyg. 2011 Aug;85(2):341-51. doi: 10.4269/ajtmh.2011.10-0501.