PMID- 25997707
OWN - NLM
STAT- MEDLINE
DCOM- 20160401
LR  - 20161125
IS  - 1708-8305 (Electronic)
IS  - 1195-1982 (Linking)
VI  - 22
IP  - 4
DP  - 2015 Jul-Aug
TI  - Short-Term Immunogenicity and Safety of an Accelerated Pre-Exposure Prophylaxis 
      Regimen With Japanese Encephalitis Vaccine in Combination With a Rabies Vaccine: 
      A Phase III, Multicenter, Observer-Blind Study.
PG  - 225-31
LID - 10.1111/jtm.12210 [doi]
AB  - BACKGROUND: The current Japanese encephalitis (JE) vaccination regimen requires 
      two doses and 4 weeks to complete, which may not always be feasible for travelers 
      on short notice. One of the primary endpoints of this phase III study was to 
      demonstrate noninferiority of immune responses to a JE vaccine following an 
      accelerated 1-week JE vaccination regimen administered concomitantly with a 
      rabies vaccine as compared to a standard 4-week JE regimen alone. In addition, 
      the immunogenicity of concomitant administration of JE and rabies vaccines 
      following standard regimens was evaluated, as well as the tolerability and safety 
      profile of each regimen under study. METHODS: Healthy adults aged 18 to </=65 years 
      were randomized to regimens with an accelerated or standard schedule: 
      JE+rabies-standard (n = 167), JE+rabies-accelerated (n = 217) or JE-standard (n = 
      56). Immunogenicity against JE antigen was assessed by a 50% plaque reduction 
      neutralization test (PRNT50 ) titer of >/=1 : 10, measured 28 days after last 
      active vaccine (LAV) administration. Solicited reactions were collected 7 days 
      after each vaccination; spontaneously reported adverse events (AEs) and serious 
      AEs were monitored up to day 57. This paper reports results until day 57. 
      RESULTS: Noninferiority of immune responses was established for 
      JE+rabies-accelerated compared to the JE-standard regimen 28 days after LAV 
      administration. Overall, 99% and 100% of subjects in the JE+rabies-accelerated 
      and JE-standard groups, respectively, achieved PRNT50 titers of >/=1 : 10 at 28 
      days after LAV administration. No impact of concomitant rabies vaccination was 
      observed either on immune responses or on the safety profile of the JE vaccine. 
      CONCLUSIONS: This was the first randomized, controlled trial that demonstrated 
      the strong short-term immunogenicity of a new, accelerated, 1-week JE-regimen, 
      which was noninferior to that of the standard regimen, with a satisfactory 
      tolerability and safety profile and no impact of concomitant rabies vaccination. 
      This accelerated regimen, if licensed, could potentially be a valid alternative 
      for individuals requiring a primary series of JE vaccination and rabies 
      pre-exposure prophylaxis on short notice.
CI  - (c) 2015 International Society of Travel Medicine.
FAU - Jelinek, Tomas
AU  - Jelinek T
AD  - The Berlin Center for Travel and Tropical Medicine, Berlin, Germany.
FAU - Burchard, Gerd D
AU  - Burchard GD
AD  - Bernhard-Nocht Institute for Tropical Medicine, Hamburg, Germany.
FAU - Dieckmann, Sebastian
AU  - Dieckmann S
AD  - Institute of Tropical Medicine and International Health, Charite, Berlin, 
      Germany.
FAU - Buhler, Silja
AU  - Buhler S
AD  - Institute of Social and Preventive Medicine, University of Zurich, Zurich, 
      Switzerland.
FAU - Paulke-Korinek, Maria
AU  - Paulke-Korinek M
AD  - Institute of Specific Prophylaxis and Tropical Medicine, Medical University of 
      Vienna, Vienna, Austria.
FAU - Nothdurft, Hans D
AU  - Nothdurft HD
AD  - Department of Infectious Diseases and Tropical Medicine, University of Munich, 
      Munich, Germany.
FAU - Reisinger, Emil
AU  - Reisinger E
AD  - Department of Tropical Medicine and Infectious Diseases, Rostock University 
      Medical Center, Rostock, Germany.
FAU - Ahmed, Khaleel
AU  - Ahmed K
AD  - Novartis Healthcare Pvt. Ltd., Hyderabad, India.
FAU - Bosse, Dietrich
AU  - Bosse D
AD  - Novartis Vaccines and Diagnostics, GmbH, Marburg, Germany.
FAU - Meyer, Seetha
AU  - Meyer S
AD  - Novartis Vaccines and Diagnostics, GmbH, Marburg, Germany.
FAU - Costantini, Marco
AU  - Costantini M
AD  - Novartis Vaccines and Diagnostics, S.r.l., Siena, Italy.
FAU - Pellegrini, Michele
AU  - Pellegrini M
AD  - Novartis Vaccines and Diagnostics, S.r.l., Siena, Italy.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150522
PL  - England
TA  - J Travel Med
JT  - Journal of travel medicine
JID - 9434456
RN  - 0 (Japanese Encephalitis Vaccines)
RN  - 0 (Rabies Vaccines)
SB  - IM
CIN - J Travel Med. 2015 Jul-Aug;22(4):219-20. PMID: 26146818
MH  - Adult
MH  - Drug Monitoring/methods
MH  - Drug Therapy, Combination/methods
MH  - Encephalitis, Japanese/*prevention & control
MH  - Humans
MH  - Immunogenetic Phenomena/*drug effects
MH  - *Japanese Encephalitis Vaccines/administration & dosage/immunology
MH  - Middle Aged
MH  - Neutralization Tests/methods
MH  - Pre-Exposure Prophylaxis/*methods
MH  - Rabies/*prevention & control
MH  - *Rabies Vaccines/administration & dosage/immunology
MH  - Time Factors
MH  - *Travel
MH  - Travel Medicine/methods
MH  - Treatment Outcome
MH  - Vaccination/methods
EDAT- 2015/05/23 06:00
MHDA- 2016/04/02 06:00
CRDT- 2015/05/23 06:00
PHST- 2015/05/23 06:00 [entrez]
PHST- 2015/05/23 06:00 [pubmed]
PHST- 2016/04/02 06:00 [medline]
AID - 10.1111/jtm.12210 [doi]
PST - ppublish
SO  - J Travel Med. 2015 Jul-Aug;22(4):225-31. doi: 10.1111/jtm.12210. Epub 2015 May 
      22.