6/24/2019 Disclosures No disclosures Evaluating Rabies Pre ‐ exposure Prophylaxis Vaccination Schedules: PATRICK SOENTJENS CHIEF PHYSICIAN, POLYCLINIC, ITM, ANTWERP CHAIR, BELGIAN STUDY GROUP TRAVEL MEDICINE MED LT COL, HEAD, CENTER FOR INFECTIOUS DISEASES, MILITARY HOSPITAL BRUSSELS 1 2 Rabies Background Background Rabies causes fatal encephalitis “The Belgium experience” Rabies PrEP Rabies PrEP: prospective studies ‐ an estimated 59.000 ‐ 70.000 human deaths every year in endemic regions Rabies PrEP: retrospective studies Discussion ‐ estimated risk for an animal bite in travellers: Conclusion calculated 0,4 % per month staying in an endemic country ‐ 3 deaths per year in travellers Hampson et al. PloS Negl Trop Dis 2015 WHO Wkly Epidemiol Rec 2010 Gautret: JTravelMed 2012; Vaccine 2012; Curr Opin Infect Dis 2012 3 4 Background Institut Pasteur de Paris The 10th of October 2017 The 12 th of Nov 2018 Un cas de rage importé en France chez un enfant 58 old Briton dies from rabies after cat bite in Morocco Hospitalisé à Lyon, le garçon de 10 ans avait été mordu par un chien contaminé lors d’un séjour en août 2017 au Sri Lanka . Only the seventh known case in the United Kingdom since 2000. England's health service issued a reminder Monday for travellers to avoid coming into contact with animals when travelling to rabies affected countries, particularly those in Asia and Africa 5 5 6 1
6/24/2019 Family statement of Brigitte the 15th of May at www.promed.org The 6th of May 2019 Norwegian woman dies from rabies "Our dear Birgitte loved animals. Our fear is that such fate may happen to others after Philippines puppy bite who have a warm heart like her. We want rabies vaccine to be included in the program for travellers to locations where the disease is present, and that people Birgitte Kallestad, 24 year old, was on holiday with become more aware of the danger. If we manage to achieve this, the death of friends when they found the puppy on a street. our sunbeam can save others. Warm greetings from the family." She fell ill soon after returning to Norway, and died on Monday at the hospital where she worked. 7 8 Background Background Rabies risk during travel: low risk – animal bite: high risk Rabies risk: prevention Start PEP Increase awareness immediately Avoid contact with street dogs, monkeys and other mammals Steffen: J Travel Med 2015 and adapted 2018 Shlim: J Travel Med 2019 9 10 Background Background Rabies risk: have a back ‐ up plan Rabies risk: start Rabies PEP procedure in time Travel insurance Washing ‐ Soap ‐ Desinfection Respective PEP schedule and HRIG WHO report 2018 Shlim: J Travel Med 2019 11 12 2
6/24/2019 Background Background Rabies risk: difficulties with Human Rabies Immunoglobulins (HRIG) Belgian Rabies PEP data 2017 with use of HRIG in BE N = 75 44 of the cases (58%) were female. In time ‐ Availability ‐ Costs? Mean age was 33 years (interquartile range 24 ‐ 51; range: 4 ‐ 85). Mean time delay between exposure and the administered HRIG was 8.7 days: Equine Rabies Immunoglobulins? ‐ 9.6 days (IQR 2,5 ‐ 9) for abroad travel ‐ 6 days (IQR 1 ‐ 4) for inland bat ‐ related risks. Mean time delay between exposure and the first administered dose of rabies vaccine was 7.7 days: ‐ 8.3 days (IQR 0 ‐ 8,5) for abroad travel ‐ 6 days (IQR 1 ‐ 4) for inland bat ‐ related risks Soentjens et al Acta Clin Belgica 2019 13 14 Background Immunescence following Rabies PEP: research gaps Belgian Rabies PEP data 2017 ITM N = 63 (of 75) One single patient had no response (RFFIT < 0.5 IU/mL) after a full 5 1 IM PEP schedule with HRIG The timing of the vaccinations and the serology test were in accordance Age = 80 years Serology testing (RFFIT) is crucial in Rabies PEP when decreasing PrEP and PEP doses Clin Infect Dis 2012 Soentjens et al Acta Clin Belgica 2019 15 16 Concept BOOST Rabies PEP schedules in Belgium (2019) Rabies pre ‐ and postexposure prophylaxis (PEP without PrEP) RFFIT: rabies rapid fluorescent focus inhibition test is key in rabies prevention procedures ‘Adequate immune response = lifelong antibodies RFFIT > 0.5 IU/mL’ Schedules D0 D3 D7 D14 D21 D28 D+10 Indications Rabies PEP after PrEP Schedule 1: 1 x 1 x No RFFIT Contact category II en III 2 intramuscular njections / 2 visits 4 intradermal injections / 1 visit 1 x 1 injection = 0.1 mL Rabies PEP without previous PrEP Schedule 2: 2 x 1 x 1 x No RFFIT Contact category II RFFIT > 0.5 IU/ml WHO guideline Exception to do RFFIT on D31 if: 4 intramuscular injections / 3 visits ‐ vaccination schedule started overseas ‐ in ‘vulnerable’ patients No PrEP schedule Risk cat III PEP IM schedule 1 x 1 x 1 x 1 x 1 x RFFIT Contact category III Schedule 3: D38 Result RFFIT > 3.0 IU/ml 5 intramuscular injections / 5 visits Naive B ‐ cells Result RFFIT > 5.0 IU/ml + Human rabies immunoglobulins (if bat ‐ related or (HRIG) immunosuppression) PEP: post ‐ exposure prophylaxis – PrEP: pre ‐ exposure prophylaxis – RFFIT: rabies rapid fluorescent focus inhibition test 17 18 3
6/24/2019 Concept BOOST Rabies PEP 2019 Rabies pre ‐ and postexposure prophylaxis (PEP without PrEP) New BE guideline 2019: sparing HRIG ‘Adequate immune response = lifelong antibodies RFFIT > 0.5 IU/mL’ HRIG only in wound ‐ same dosage (20 IU/kg) or less inject minimal 2 mL RFFIT > 3.0 IU/ml BE guideline RFFIT > 0.5 IU/ml WHO guideline No PrEP schedule Risk cat III PEP schedule https://www.itg.be/Files/docs/Reisgeneeskunde/PEP_Rabies_ENG.pdf 19 20 Background Background Tackling the high rabies human case fatality rate Rabies risk: promote pre ‐ exposure vaccination To use newer practical regimens ‐ 1 deceased 10 y France ‐ 1 deceased 58 y UK Revised WHO recommendations for rabies pre ‐ exposure prophylaxis ‐ 1 deceased 24 y Norway in travellers: avoid bumpy roads, select the highway! PrEP + PEP 2ID mL Intradermal PrEP 2 0.4 mL PEP 1 0.4 mL Total visits 3 0.8 mL Knopf, Steffen: J Travel Med 2019 21 22 Rabies Rabies PrEP Background “The Belgium experience” New WHO publication since the 17th of April 2018: Rabies PrEP Technical Report Rabies PrEP: prospective studies Guidelines on PrEP and PEP Rabies PrEP: retrospective studies Discussion Conclusion 23 24 4
6/24/2019 Background Rabies PrEP WHO publication of the 17th of Apr 2018: WHO guidelines > 2 ‐ visit regimen for rabies PrEP: 2ID or 2IM Promote intradermal (ID) schedules = ‐ ID as effective as IM injection ‐ Technical guidance: ID technique is not difficult ‐ Use always single ‐ dose injections on two sites during each visit 2²ID 2 1 IM But ID schedules are off ‐ label… 25 26 Rabies PrEP Rabies PrEP WHO guidelines: BE guideline from 1st May 2018: two ‐ visit regimens WHO guidelines: 1 ‐ visit regimen: 1ID or 1IM New Rabies PrEP regimens that are recommended in first line for individuals of all ages are: Day 0 Day 7 ‐ 2 ‐ site ID vaccine administration on day 0 and 7 2²ID double dose 2x 0.1 ml on day 0 and day 7 ‐ 1 ‐ site IM vaccine administration on day 0 and 7 2 1 IM single dose 1x ampoule (1ml) on day 0 and day 7 1²ID Rabies PrEP completed, 1 1 IM additional vaccines needed after bite / risk 27 28 Who is using this PrEP regimens? Off ‐ label Rabies PrEP guideline in BE (from 1st of May 2018) Guideline to use off ‐ label Preferred rabies PrEP schedule: two ‐ visit schedules 2²ID Belgium, The Netherlands, Canada, Japan, … Use a one visit rabies PrEP schedule in last ‐ minute travelers 2 1 IM Belgium, Denmark, The Netherlands, Canada,… 1²ID or 1 1 IM Belgium,… ‐ ID 0.1ml No guideline to use off ‐ label: optional by practitioner d 0 ID (double dose) > d X ID after travel (double dose) 2²ID Ireland?, Australia?, New Zealand? ‐ IM 1.0 ml 2 1 IM d 0 IM > d X after travel Germany Add stamp Guidelines on 2IM + booster Rabies PrEP completed, additional vaccines needed Adapted 3 1 IM: 2 1 IM + 1 1 IM Switzerland after bite / risk Unchanged guidelines on 3IM + booster Adapted 3 1 IM + booster 1 1 IM UK, USA, Germany, France, Italy, Changing the PrEP strategy from strictly 3 visits to 2 visits > to 1 visit as an option Spain,… 29 30 5
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