PMID- 30566636
OWN - NLM
STAT- MEDLINE
DCOM- 20200917
LR  - 20200917
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 69
IP  - 5
DP  - 2019 Aug 16
TI  - Comparative Immunogenicity and Safety Trial of 2 Different Schedules of 
      Single-visit Intradermal Rabies Postexposure Vaccination.
PG  - 797-804
LID - 10.1093/cid/ciy983 [doi]
AB  - BACKGROUND: Effective and safe single-visit rabies vaccination for pre- and 
      postexposure prophylaxis (PrEP and PEP) could substantially simplify rabies 
      prevention and therefore increase compliance. METHODS: In a comparative trial, 
      303 healthy adults received a primary vaccination that consisted of 2 intradermal 
      (ID) doses of 0.1 mL of the purified chicken embryo cell vaccine (PCEV) during a 
      single visit. One year later, participants were randomly assigned to receive 
      either 4 or 2 ID PEP booster doses of 0.1 mL PCEV during a single visit. The 
      primary endpoint for immunogenicity was the percentage of participants with an 
      adequate antibody level (>0.5 IU/mL) 7 days after the booster doses. The safety 
      endpoint was the proportion of participants who developed adverse events (AEs) 
      following primary and/or booster vaccination. RESULTS: All participants, except 1 
      (99.3%) in each study group, had a rabies antibody titer >0.5 IU/mL on day 7 
      following the booster schedules. Participants exposed to the 4-dose PEP schedule 
      had a geometric mean titer of 20 IU/mL vs 14 IU/mL for the 2-dose PEP schedule (P 
      = .0228). Local reactions at the injection site following PrEP and PEP were mild 
      and transient and only seen in 14.9% and 49.6%-53% of the participants, 
      respectively. No serious AEs were reported. CONCLUSIONS: In healthy adults, a 
      2-dose (2 x 0.1 mL) single-visit ID PEP schedule was as immunologically adequate 
      and safe as a 4-dose (4 x 0.1 mL) single-visit PEP schedule 7 to 28 months 
      following a 2-dose (2 x 0.1 mL) single-visit ID PREP. CLINICAL TRIALS 
      REGISTRATION: EudraCT 2014-00183612.
CI  - (c) The Author(s) 2018. Published by Oxford University Press for the Infectious 
      Diseases Society of America. All rights reserved. For permissions, e-mail: 
      journals.permissions@oup.com.
FAU - Soentjens, Patrick
AU  - Soentjens P
AD  - Center for Infectious Diseases, Queen Astrid Military Hospital, Brussels.
AD  - Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.
FAU - De Koninck, Katrien
AU  - De Koninck K
AD  - Center for Infectious Diseases, Queen Astrid Military Hospital, Brussels.
FAU - Tsoumanis, Achilleas
AU  - Tsoumanis A
AD  - Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.
FAU - Herssens, Natacha
AU  - Herssens N
AD  - Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.
FAU - Van Den Bossche, Dorien
AU  - Van Den Bossche D
AD  - Center for Infectious Diseases, Queen Astrid Military Hospital, Brussels.
AD  - Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.
FAU - Terryn, Sanne
AU  - Terryn S
AD  - National Reference Centre for Rabies, Sciensano, Brussels.
FAU - Van Gucht, Steven
AU  - Van Gucht S
AD  - National Reference Centre for Rabies, Sciensano, Brussels.
FAU - Van Damme, Pierre
AU  - Van Damme P
AD  - Center for the Evaluation of Vaccination, University of Antwerp, Belgium.
FAU - Van Herrewege, Yven
AU  - Van Herrewege Y
AD  - Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.
FAU - Bottieau, Emmanuel
AU  - Bottieau E
AD  - Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.
LA  - eng
SI  - EudraCT/2014-00183612
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Rabies Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Neutralizing/immunology
MH  - Antibodies, Viral/immunology
MH  - Female
MH  - Humans
MH  - *Immunization Schedule
MH  - Immunization, Secondary
MH  - Injections, Intradermal
MH  - Injections, Intramuscular
MH  - Male
MH  - *Post-Exposure Prophylaxis
MH  - Rabies/*prevention & control
MH  - Rabies Vaccines/administration & dosage/*immunology
MH  - Vaccination/statistics & numerical data
MH  - Young Adult
OTO - NOTNLM
OT  - Rabies
OT  - intradermal
OT  - postexposure prophylaxis
OT  - pre-exposure prophylaxis
OT  - single-visit
EDAT- 2018/12/20 06:00
MHDA- 2020/09/18 06:00
CRDT- 2018/12/20 06:00
PHST- 2018/08/14 00:00 [received]
PHST- 2018/12/10 00:00 [accepted]
PHST- 2018/12/20 06:00 [pubmed]
PHST- 2020/09/18 06:00 [medline]
PHST- 2018/12/20 06:00 [entrez]
AID - 5253211 [pii]
AID - 10.1093/cid/ciy983 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2019 Aug 16;69(5):797-804. doi: 10.1093/cid/ciy983.