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

Abstract

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.

British HIV Association Guidelines on the Use of Vaccines in HIV‐Positive Adults 2015

“…Responses are long‐lived, and emerging data suggest that further booster doses may be scheduled 10 years following the first booster . A randomised clinical trial evaluated short‐term antibody responses to an accelerated course of 2 vaccine doses 1 week apart (and co‐administered with rabies vaccine) in healthy persons aged 18–65 years . Short‐term immunogenicity with the accelerated course was non‐inferior to that measured with the standard schedule.…”

The changing epidemiology of Japanese encephalitis and New data: the implications for New recommendations for Japanese encephalitis vaccine

“…A recent accelerated dosing study design (1,7 days) v49-23 Phase 3 observer blinded randomized multicenter study of 661 adults was conducted [ 29 ]. The study was also designed to look at compatibility with rabies vaccine which may be given on a similar schedule.…”

“…Injection site tenderness was the most common event in both groups with similar numbers of events. Both the standard schedule and accelerated dosing schedule require a booster after one year and require three doses but accelerated dosing should allow more coverage [ 29 ].…”

Risk assessment for Japanese encephalitis vaccination

“…IXIARO is usually given with a dose interval of one month, however this can be shortened to one week if needed. 31 The long-term duration of protection of JE vaccines is not yet clear, but immunity is likely to wane faster in the absence of boosting by natural exposure to JEV such as might result from long term residence in an endemic area. In the majority of cases only one vaccine will be availableoutside rare instances of intolerance or allergy the decision as to which vaccine to use is relatively unimportant compared with the decision whether to vaccinate or not.…”