Single dose for rabies preimmunization P Khawplod 1

Single dose for rabies pre-immunization P. Khawplod 1 , H. Wilde 2 , T. Kamolthum 3 , Visith Sitprija 1. 1 Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok, Thailand. 2 Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand. 3 Provincial Public Health Office of Pitsanulok , Thailand.

The Ab response in incomplete PET cases (1 - 3 injections) Subjects I. No previous rabies vaccination II. 1 -3 injections previously n Day 0 10 <0. 03 20 Day 7 Day 14 Day 28 0. 06 7. 13 6. 44 (<0. 03– 0. 2) (1. 15 -58. 8) (1. 8 -20. 7) 0. 26 6. 73 38. 91 23. 86 (<0. 03 -22. 0) (1. 1 -80. 5) (16. 7 -248. 4) (6. 7 -175. 6) All subjects received TRC-ID 2 -2 -2 -0 -1 -1 (PVRV lot. no. L 1012, potency 8. 7 IU/0. 5 m. L)

Pre-exposure vaccination Shorten time & reduce cost

Objective : To evaluate the immune memory of two abbreviated pre-exposure rabies vaccination schedules

Study 1 n One week schedule ( 3 injections on day 0, 3, 7) Study 2 n One clinic visit (Single dose)

One week schedule Gr. A ID (2 sites) on day 0, 7 , 28 Gr. B ID (2 sites) on day 0, 3, 7 Gr. C IM on day 0, 3, 7 PVRV potency 7. 5 IU/0. 5 m. L

One week schedule Booster : ID (2 sites) on day 0, 3 1 year later Blood collection : before booster (1 year) , 7 and 14 days PVRV potency 7. 5 IU/0. 5 m. L

Booster : ID(2 sites) on day 0, 3 1 year later Group A. IDx 2 day 0, 7, 28 Day 360 Day 367 Age 18 -35 GMT M/F 5/11 Range >0. 5 IU/ml (n=16 ) B. IDx 2 day 0, 3, 7 Age 18 -32 GMT M/F 4/12 Range (n=16 ) C. IM day 0, 3, 7 (n=20 ) >0. 5 IU/ml Age 18 -40 GMT M/F 8/12 Range >0. 5 IU/ml Day 374 0. 96 29. 14 49. 39 0. 32 -2. 95 6. 7 -227. 8 13. 1 -308. 4 81% 100% 1. 12 22. 99 105. 08 0. 30 -4. 76 5. 9 -295. 4 26. 1 -496. 7 94% 100% 0. 97 35. 16 125. 0 0. 27 -4. 76 12. 0 -191. 5 29. 7 -800. 0 80% 100%

One injection for 1 - 4 years ( at QSMI ) Previous vaccination regimen Times (yrs) day 0 day 7 day 14 day 28 PVRV ID 8 mths 0. 08 16. 0 25. 0 19. 3 PVRV ID 1 neg 1. 1 18. 2 6. 7 PVRV ID 2 0. 18 5. 0 16. 7 11. 8 PVRV ID 3 1. 14 36. 4 34. 9 20. 8 unknown IM 4 neg 2. 4 30. 6 32. 0 neg 0. 06 5. 56 5. 84 No previous TRC-ID vaccination 2 -2 -2 -0 -1 -1

Conclusions: n 3 injections on day 0, 3, 7 is as immunogenic as 3 injections on day 0, 7, 28 n Provide at least 1 year of immune memory

Single dose for rabies pre-immunization ( one clinic visit )

Single dose for rabies pre-immunization Pre-immunization ID 0. 1 ml (2 sites) on day 0 Booster ( 1 year later ) ID 0. 1 ml ( 2 sites ) on day 0, 3 PVRV lot no 0525 potency 7. 5 IU/0. 5 m. L

Single dose rabies pre-immunization Primary vaccination Day 360 Day 367 Day 374 ( Before booster ) ( 7 days) ( 14 days ) I. ID 0. 1 ml (2 sites) on day 0 0. 41 9. 15 51. 96 (0. 06– 3. 7) (3. 36 -22. 6) 10/10 100% (13. 6 -141. 4) 9/9 100% booster ID 0. 1 ml (2 sites ) day 0, 3 >0. 5 IU/ml 5/13 38%

Single dose rabies pre-immunization Single dose injection Primary vaccination I. ID 0. 1 ml (2 sites) on day 0 II. TRC-ID 2 -2 -2 -0 -1 -1 (PVRV) No previous rabies vaccination III. TRC-ID 2 -2 -2 -0 -1 -1 (PCEC) No previous rabies vaccination Day 360 Day 367 Day 374 (Before booster) ( 7 days) ( 14 days) 0. 41 9. 15 51. 96 (0. 06– 3. 7) (3. 36 -22. 6) (13. 6 -141. 4) 5/13 38% 10/10 100% 9/9 100% 0. 06 5. 56 (0. 03 – 0. 15) 0% (1. 15 - 53. 8) 100% 0. 06 8. 54 (<0. 03– 0. 3) 0% (1. 56 – 27. 3) 100% <0. 03

Conclusion: n One clinic visit ( ID 0. 1 ml (2 sites) one time) provide at least 1 year of immune memory

Single dose for rabies pre-immunization in Petchaboon province n Pre-immunization vaccination ID 0. 1 ml (1 site) on day 0 n Booster ( 1 or 3 years later ) ID 0. 1 ml ( 1 site ) on day 0, 3 PCEC Lot no 725 potency 7. 25 IU/m. L

Booster : ID 0. 1 ml (1 site) on day 0, 3 1 year later Subject no. Day 360 Day 367 Day 374 01032 0. 07 3. 69 6. 59 01042 0. 1 2. 29 6. 04 01049 0. 06 18. 74 21. 51 01070 0. 18 2. 62 22. 15 01098 neg 5. 00 9. 72

Booster : ID 0. 1 ml (1 site) on day 0, 3 3 years later Subject no. Day 360 Day 367 Day 374 03022 0. 27 2. 09 20. 57 03027 0. 71 3. 08 5. 73 03050 0. 13 4. 18 4. 42 03051 0. 15 1. 04 3. 56 03059 0. 46 1. 68 5. 98 03066 0. 09 2. 13 7. 76 03082 0. 07 1. 00 19. 28 03093 0. 2 1. 04 14. 23

Conclusions: • 3 injections on day 0, 3 and 7 • One clinic visit ID 0. 1 ml ( 2 sites) one time Provide immune memory at least 1 year or more

Application for rabies pre-immunization • reliable booster vaccination • long lasting • ? ? NEED FURTHER STUDIES

Thank you for your attention

Preventions Animal control Pre-exposure vaccination Bite Prevention PET = 100% Exposed