PMID- 21150279
OWN - NLM
STAT- MEDLINE
DCOM- 20110727
LR  - 20211020
IS  - 1554-8619 (Electronic)
IS  - 1554-8600 (Print)
IS  - 1554-8600 (Linking)
VI  - 6
IP  - 12
DP  - 2010 Dec
TI  - Long term immunity to live attenuated Japanese encephalitis chimeric virus 
      vaccine: randomized, double-blind, 5-year phase II study in healthy adults.
PG  - 1038-46
AB  - In a randomized, double-blind study, 202 healthy adults were randomized to 
      receive a live, attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) 
      and placebo 28 days apart in a cross-over design. A subgroup of 98 volunteers 
      received a JE-CV booster at month 6. Safety, immunogenicity, and persistence of 
      antibodies to month 60 were evaluated. There were no unexpected adverse events 
      (AEs) and the incidence of AEs between JE-CV and placebo were similar. There were 
      three serious adverse events (SAE) and no deaths. A moderately severe case of 
      acute viral illness commencing 39 days after placebo administration was the only 
      SAE considered possibly related to immunization. 99% of vaccine recipients 
      achieved a seroprotective antibody titer >/= 10 to JE-CV 28 days following the 
      single dose of JE-CV, and 97% were seroprotected at month 6. Kaplan Meier 
      analysis showed that after a single dose of JE-CV, 87% of the participants who 
      were seroprotected at month 6 were still protected at month 60. This rate was 96% 
      among those who received a booster immunization at month 6. 95% of subjects 
      developed a neutralizing titer >/= 10 against at least three of the four strains of 
      a panel of wild-type Japanese encephalitis virus (JEV) strains on day 28 after 
      immunization. At month 60, that proportion was 65% for participants who received 
      a single dose of JE-CV and 75% for the booster group. These results suggest that 
      JE-CV is safe, well tolerated and that a single dose provides long-lasting 
      immunity to wild-type strains.
FAU - Nasveld, Peter E
AU  - Nasveld PE
AD  - Australian Army Malaria Institute, Queensland, Australia.
FAU - Ebringer, Andrew
AU  - Ebringer A
FAU - Elmes, Nathan
AU  - Elmes N
FAU - Bennett, Sonya
AU  - Bennett S
FAU - Yoksan, Sutee
AU  - Yoksan S
FAU - Aaskov, John
AU  - Aaskov J
FAU - McCarthy, Karen
AU  - McCarthy K
FAU - Kanesa-thasan, Niranjan
AU  - Kanesa-thasan N
FAU - Meric, Claude
AU  - Meric C
FAU - Reid, Mark
AU  - Reid M
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101201
PL  - United States
TA  - Hum Vaccin
JT  - Human vaccines
JID - 101265291
RN  - 0 (Antibodies, Viral)
RN  - 0 (Japanese Encephalitis Vaccines)
RN  - 0 (Placebos)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral/blood
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Encephalitis, Japanese/prevention & control
MH  - Female
MH  - Human Experimentation
MH  - Humans
MH  - Immunization, Secondary/methods
MH  - Japanese Encephalitis Vaccines/administration & dosage/adverse 
      effects/*immunology
MH  - Male
MH  - Middle Aged
MH  - Placebos/administration & dosage
MH  - Time Factors
MH  - Vaccination/methods
MH  - Vaccines, Attenuated/administration & dosage/adverse effects/immunology
MH  - Young Adult
PMC - PMC3060383
EDAT- 2010/12/15 06:00
MHDA- 2011/07/28 06:00
PMCR- 2010/12/01
CRDT- 2010/12/15 06:00
PHST- 2010/12/15 06:00 [entrez]
PHST- 2010/12/15 06:00 [pubmed]
PHST- 2011/07/28 06:00 [medline]
PHST- 2010/12/01 00:00 [pmc-release]
AID - 13057 [pii]
AID - 1554-8600-6-12-14 [pii]
AID - 10.4161/hv.6.12.13057 [doi]
PST - ppublish
SO  - Hum Vaccin. 2010 Dec;6(12):1038-46. doi: 10.4161/hv.6.12.13057. Epub 2010 Dec 1.