Comparative immunogenicity and safety trial of 2 different schedules of single-visit intradermal rabies postexposure vaccination

Patrick Soentjens, Katrien De Koninck, Achilleas Tsoumanis, Natacha Herssens, Dorien Van Den Bossche, Sanne Terryn, Steven Van Gucht, Pierre Van Damme, Yven Van Herrewege, Emmanuel Bottieau

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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.

Original languageEnglish
JournalClinical Infectious Diseases
Issue number5
Pages (from-to)797-804
Number of pages8
Publication statusPublished - 2019


  • Rabies
  • postexposure prophylaxis
  • pre-exposure prophylaxis
  • intradermal
  • single-visit
  • 4-SITE


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