PMID- 24351795
OWN - NLM
STAT- MEDLINE
DCOM- 20140714
LR  - 20240420
IS  - 1999-4915 (Electronic)
IS  - 1999-4915 (Linking)
VI  - 5
IP  - 12
DP  - 2013 Dec 9
TI  - Preclinical and clinical development of a YFV 17 D-based chimeric vaccine against 
      West Nile virus.
PG  - 3048-70
LID - 10.3390/v5123048 [doi]
AB  - Substantial success has been achieved in the development and implementation of 
      West Nile (WN) vaccines for horses; however, no human WN vaccines are approved. 
      This review focuses on the construction, pre-clinical and clinical 
      characterization of ChimeriVax-WN02 for humans, a live chimeric vaccine composed 
      of a yellow fever (YF) 17D virus in which the prM-E envelope protein genes are 
      replaced with the corresponding genes of the WN NY99 virus. Pre-clinical studies 
      demonstrated that ChimeriVax-WN02 was significantly less neurovirulent than YF 
      17D in mice and rhesus and cynomolgus monkeys. The vaccine elicited neutralizing 
      antibody titers after inoculation in hamsters and monkeys and protected immunized 
      animals from lethal challenge including intracerebral inoculation of high dose of 
      WN NY99 virus. Safety, viremia and immunogenicity of ChimeriVax-WN02 were 
      assessed in one phase I study and in two phase II clinical trials. No safety 
      signals were detected in the three clinical trials with no remarkable differences 
      in incidence of adverse events (AEs) between vaccine and placebo recipients. 
      Viremia was transient and the mean viremia levels were low. The vaccine elicited 
      strong and durable neutralizing antibody and cytotoxic T cell responses. WN 
      epidemiology impedes a classical licensure pathway; therefore, innovative 
      licensure strategies should be explored.
FAU - Dayan, Gustavo H
AU  - Dayan GH
AD  - Sanofi Pasteur, 1 Discovery Drive, Swiftwater,, PA 18370, USA. 
      Gustavo.Dayan@sanofipasteur.com.
FAU - Pugachev, Konstantin
AU  - Pugachev K
FAU - Bevilacqua, Joan
AU  - Bevilacqua J
FAU - Lang, Jean
AU  - Lang J
FAU - Monath, Thomas P
AU  - Monath TP
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20131209
PL  - Switzerland
TA  - Viruses
JT  - Viruses
JID - 101509722
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (ChimeriVax)
RN  - 0 (Drug Carriers)
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Vaccines, Synthetic)
RN  - 0 (West Nile Virus Vaccines)
SB  - IM
MH  - Animals
MH  - Antibodies, Neutralizing/blood
MH  - Antibodies, Viral/blood
MH  - Clinical Trials as Topic
MH  - Cricetinae
MH  - Disease Models, Animal
MH  - *Drug Carriers
MH  - Drug Evaluation, Preclinical
MH  - *Genetic Vectors
MH  - Humans
MH  - Macaca fascicularis
MH  - Mice
MH  - Survival Analysis
MH  - T-Lymphocytes, Cytotoxic/immunology
MH  - Vaccines, Attenuated/administration & dosage/adverse effects/genetics/immunology
MH  - Vaccines, Synthetic/administration & dosage/adverse effects/genetics/immunology
MH  - West Nile Virus Vaccines/administration & dosage/adverse 
      effects/genetics/*immunology
MH  - West Nile virus/genetics/*immunology
MH  - Yellow fever virus/*genetics
PMC - PMC3967160
EDAT- 2013/12/20 06:00
MHDA- 2014/07/16 06:00
PMCR- 2013/12/01
CRDT- 2013/12/20 06:00
PHST- 2013/08/16 00:00 [received]
PHST- 2013/11/11 00:00 [revised]
PHST- 2013/11/18 00:00 [accepted]
PHST- 2013/12/20 06:00 [entrez]
PHST- 2013/12/20 06:00 [pubmed]
PHST- 2014/07/16 06:00 [medline]
PHST- 2013/12/01 00:00 [pmc-release]
AID - v5123048 [pii]
AID - viruses-05-03048 [pii]
AID - 10.3390/v5123048 [doi]
PST - epublish
SO  - Viruses. 2013 Dec 9;5(12):3048-70. doi: 10.3390/v5123048.