Hep b vaccine – best schedule & a quiz !

Hep B vaccine - Ideal Schedule.
Also quiz on Hep B vaccination

1. Hep B Vaccine – most effective schedule (& a quiz!) Dr Gaurav Gupta MAAP, MIAP Author of ‘Clippings’ in Indian Pediatrics since 2002 www.charakclinics.com SAVE – Goa, 20 th April, 2013

2. Conflict of Interest Received grants from various vaccine manufacturers including - Sanofi Pasteur - GSK - MSD - Pfizer etc.

3. Scope Why do we need vaccination for Hep B? What is an ideal vaccination schedule? Quiz !

4. Dr. Gaurav Gupta, Charak Care Clinics, Mohali

5. Leading Causes of Infectious Disease Deaths Worldwide Disease Lower respiratory tract infections Diarrheal diseases HIV/AIDS Tuberculosis Hepatitis viruses Hepatitis B virus Hepatitis C virus Malaria Pertussis Neonatal tetanus Measles Est. Deaths per Year ~4.2 million ~2.2 million ~2.0 million ~1.5 million ~1 million ~620,000 ~366,000* ~900,000 ~295,000 ~213,000 ~197,000 Source: WHO, UNICEF, Perz et al, J Hepatology, 2006

6. Geographic distribution of chronic hepatitis B virus (HBV) infection — worldwide , 2006*

7. High ( > 8%): 45% of global population lifetime risk of infection >60% early childhood infections common Intermediate (2%-7%): 43% of global population lifetime risk of infection 20%-60% infections occur in all age groups Low (<2%): 12% of global population lifetime risk of infection <20% most infections occur in adult risk groups Global Pattern of Chronic HBV Infection

8. Problem statement INDIA: Falls in intermediate endemicity group HBsAg prevalence between 2% to 7%. Estimated 43-45 million cases per year. 40 million carriers. 100,000 death annually by disease related to HBV infection. Of 25 million newborn annually, 1 million runs lifetime risk of HBV infection

9. HBsAg HBcAg HBeAg Hepatitis B Virus

10. EXPOSURE Acute hepatitis B infection Asymptomatic Or Subclinical infection Clinical infection -jaundice -flu like symptom Fulminant hepatitis Death Chronic Carrier Recovery Or Immunity Minimal liver Disease Chronic Hepatitis Primary hepatocellular carcinoma cirrhosis DEATH

11. Chronic Hepatitis B Virus Infection Chronic viremia Responsible for most mortality Overall risk 10 % 25 % of chronic HBV patients will die due to liver disease Higher risk with early infection

12. Risk of Chronic HBV Carriage by Age of Infection

13. Global HBV-Related Deaths By Age at Acquisition of Infection Perinatal Period (21%) Early Childhood Period (48%) children < 5 Late Period (31%) children >5 adolescents adults

14. THE BEST PREVENTIVE METHOD IS VACCINATION Hepatitis B

15. Success of Hepatitis B vaccine

16. Mechanism of Long-Term Protection with Hepatitis B Vaccine 18 Primary vaccination series Immune memory Anamnestic antibody response Rapid rise in anti-HBs Protection from infection Exposure to HBV

17. 19 Serologic Response to Booster Dose of Hepatitis B Vaccine Primary series Booster dose (simulating natural infection) Source: Williams and Goldstein, CDC 2 weeks post-booster 4 weeks post-booster 1 year post-booster

18. 20 Long-Term Protection with Hepatitis B Vaccine Vaccine provides long-term protection Immunity persists despite loss of anti-HBs documented protection up to 15 years lifelong protection likely continued follow-up needed to determine duration of protection Booster doses of hepatitis B vaccine NOT currently recommended

19. Questions needed to be asked regarding Ideal Schedule for Hep B vaccine? 1. Has it been used for extensive period of time? 2. Does it protect the highest “at risk” population? 3. Are there enough evidence regarding its effectiveness? 4. Are other countries using the same in their National Schedules? 5. Can it be piggy-backed on our National Schedule?

20. Golden Principles to Follow while choosing the Schedule for Hep B Immunization 1st Dose – At birth - Prevents vertical transmission 2nd Dose – 4 wk later – Limited seroconversion after 1 st dose, hence closely spaced second dose – prevents immediate horizontal transmission 3rd Dose -- Min 8 weeks after 2nd Dose, -- Min 16 weeks after 1st Dose, -- After 24 weeks age, ( ACIP/ AAP recommendations ) Increased gap between 2 nd & 3 rd dose increases Ab titres

21. Possible schedules for Hep B vaccination Hep B vaccine may be given in any of the following schedules: ( i ) Birth, 1 and 6 months (ii) Birth, 6 and 14 weeks (iii) 6, 10 and 14 weeks (iv) Birth, 6 weeks, 6 months (v) Birth, 6 weeks,10 weeks, 14 weeks The IDEAL schedule is 0 1 6 months.

22. Importance of vaccination schedule at 0-1-6 mo/o vs 2-4-6 mo/o. Group 1 Hep.B at 0-1-6 Group 2 Hep.B at 2-4-6 Anti- HBs  10 mIU / mL 47% 9% Greenberg D et al.- Ped . Inf. Dis. Journal. 21(8):769-776, August 2002 Results: Anti-HBs Post-dose 2

23. Importance of vaccination schedule at 0-1-6 mo/o vs 2-4-6 mo/o. Group 1 Hep.B at 0-1-6 Group 2 Hep.B at 2-4-6 Anti- HBs  10 mIU / mL 100% [97.2 ; 100] 99.0% [94.3 ; 99.4] GMTs 3 643 mIU / mL [502;709] 1 052 mIU / mL [163;253] Greenberg D et al.- Ped . Inf. Dis. Journal. 21(8):769-776, August 2002 Results: Anti-HBs Post-dose 3

24. Ab titres ( ShanvacB ) with 0-1-2 & 0-1-6 schedules

25. GMT in infant vaccinated against Hepatitis B by different vaccination schedules

26. Comparison of vaccination schedule in different countries throughout world Country Schedule USA Birth, 1-2, 6-18 m Canada Birth, 1, 6m England Birth, 1, 2, 6 Germany 2,4, 11-14 m South Africa 6,10,14 weeks Australia 0, 2, 4, 6m China Birth, 1, 6m India Birth, 6,10,14 weeks

27. International Schedules Majority of schedules begin at birth Most end at 6 months age or more Gap of at least 8 weeks between 2 nd and 3 rd doses If the gap is less, then a 4 th dose given Majority have monovalent Hep B vaccine

28. AAP recommendations Administer Monovalent HepB to all newborns before hospital discharge The second dose should be administered at age of 1 to 2 months The final dose should be administered no earlier than age 24 weeks

29. IAP Recommendations – Consensus Statement 2012 IAP now recommends 0 – 6 week – 6 month schedule for routine Hepatitis-B vaccination in office practice for children: the first dose at birth second dose at 6 weeks and third dose at 6 months Administering Birth dose to all infants before hospital discharge critical Final dose not to be administered before 6m of age

30. Rationale Closer to immunologically ideal and most widely used 0-1-6 months schedule Confirms to latest ACIP recommendations wherein the final dose of Hep B vaccine is administered no earlier than age 24 weeks and at least 16 weeks after the first dose. 0-1-6 is the schedule widely followed across the world and for which there is abundant evidence of effectiveness (Taiwan, Thailand and USA) The classic 0, 1, and 6 months schedule yields a high seroconversion rates and higher titers of anti-HBs that will persist for an extended period of time.

31. Quiz – All the best ! Anoushka , a 32 year mother has been tested to be HbsAg + ve during delivery. Till what (maximum) time after birth would you recommend HBIG administration? Within 12 hours only Within 24 hours Within 48 hours Within 7 days

32. Quiz – All the best ! Anoushka , a 32 year mother has been tested to be HbsAg + ve during delivery. Till what (maximum) time after birth would you recommend HBIG administration? Within 12 hours only Within 24 hours Within 48 hours Within 7 days

33. Anoushka also wants to know if she can Breastfeed the baby? No, top feed only BF after completing 3 doses of vaccine BF from birth BF only if received HBIG

34. Anoushka also wants to know if she can Breastfeed the baby? No, top feed only BF after completing 3 doses of vaccine BF from birth BF only if received HBIG

35. When should this baby (of Anoushka ) be tested for Hep B disease? At birth At 3 months At 6 months At 9 months

36. When should this baby (of Anoushka ) be tested for Hep B disease? At birth At 3 months At 6 months At 9 months

37. How soon after taking Hep B vaccine can someone donate blood? Immediately, there is no C/I 1 month 3 months 6 months

38. How soon after taking Hep B vaccine can someone donate blood? Immediately, there is no C/I 1 month 3 months 6 months (Similarly draw blood for testing before vaccination with Hep B vaccine)

39. After seeing this excellent presentation you want to know if you are really protected against Hep B. What should you do? You have taken 3 doses, you are obviously protected Do an anti-HBs immediately. Do an HBsAg immediately You need to take 1 dose & then test for anti-HBs You need to take all 3 doses again & then test for anti-HBs

40. After seeing this excellent presentation you want to know if you are really protected against Hep B. What should you do? You have taken 3 doses, you are obviously protected Do an anti-HBs immediately. Do an HBsAg immediately You need to take 1 dose & then test for anti-HBs You need to take all 3 doses again & then test for anti-HBs

41. Who all should be tested for antibodies after Hep B vaccination? Everyone Immunodeficient & Hemodialysis cases Health care workers dealing with blood & blood products Infants of HBsAg + ve mother Family members of HBsAg + ve person

42. Who all should be tested for antibodies after Hep B vaccination? Everyone Immunodeficient & Hemodialysis cases Health care workers dealing with blood & blood products Infants of HBsAg + ve mother Family members of HBsAg + ve person

43. What is the protective levels of anti-HBs for preventing Hep B disease? 0.1 mIU /ml 1 mIU /ml 10 mIU /ml 100 mIU /ml

44. What is the protective levels of anti-HBs for preventing Hep B disease? 0.1 mIU /ml 1 mIU /ml 10 mIU /ml 100 mIU /ml

45. You have been tested 2 months after completing a course of Hep B vaccination, and your titres are below 10, what should be done? Nothing can be done, you will remain susceptible Do an HBsAg t/r/o HBV infection Repeat another course, and if your titres remain low, then you will be susceptible If the second course fails, try ID Hep B Vaccine If the second course fails, try a course of double dose Twinrix

46. You have been tested 2 months after completing a course of Hep B vaccination, and your titres are below 10, what should be done? Nothing can be done, you will remain susceptible Do an HBsAg t/r/o HBV infection Repeat another course, and if your titres remain low, then you will be susceptible If the second course fails, try ID Hep B Vaccine If the second course fails, try a course of double dose Twinrix

47. You (the doctor) have been tested after 2 months and your titres are above 10, when should you be tested again? Do you need a booster as a HCW? No need for tests & no booster – you are protected for life Tested every year, booster if level below 10 Tested every 5 years, booster as above Tested every 10 years, booster as above

48. You (the doctor) have been tested after 2 months and your titres are above 10, when should you be tested again? Do you need a booster as a HCW? No need for tests & no booster – you are protected for life Tested every year, booster if level below 10 Tested every 5 years, booster as above Tested every 10 years, booster as above

49. In which patients would you consider repeated testing of anti-HBs Ab ? In doctors In patients with chronic liver disease In patients of CRF In HIV + ve & immunocompromised children

50. In which patients would you consider repeated testing of anti-HBs Ab ? In doctors In patients with chronic liver disease In patients of CRF In HIV + ve & immunocompromised children

51. Your staff has accidentally put the Hep B vaccine in the freezer compartment & it is now frozen. What should you do? It has to be discarded Thaw it gently and reuse once it is completely liquid again Use it as a combination vaccine with DPT + Hib

52. Your staff has accidentally put the Hep B vaccine in the freezer compartment & it is now frozen. What should you do? It has to be discarded Thaw it gently and reuse once it is completely liquid again Use it as a combination vaccine with DPT + Hib

53. B/o Arti has received the first dose of Hep B vaccine with a different doctor. You do not stock the same brand of Hep B vaccine. What should you do? Ask her to go back to the same doctor Buy the same brand and give to the child by calling it again after a few days Use whatever brand is available with you

54. B/o Arti has received the first dose of Hep B vaccine with a different doctor. You do not stock the same brand of Hep B vaccine. What should you do? Ask her to go back to the same doctor Buy the same brand and give to the child by calling it again after a few days Use whatever brand is available with you

55. While doing a procedure on a patient of unknown HBsAg status, your resident Dr Nitin gets a needlestick injury. What should be done? If he is documented fully immunized – nothing Documented fully immunized – 1 dose of Hep B vaccine Unvaccinated / partially vaccinated – Hep B vaccine as per schedule immediately Unvaccinated/ partially vaccinated – Hep B vaccine + HBIG immediately

56. While doing a procedure on a patient of unknown HBsAg status, your resident Dr Nitin gets a needlestick injury. What should be done? If he is documented fully immunized – nothing Documented fully immunized – 1 dose of Hep B vaccine Unvaccinated / partially vaccinated – Hep B vaccine as per schedule immediately Unvaccinated/ partially vaccinated – Hep B vaccine + HBIG immediately

57. While doing a procedure on an HBsAg + ve patient, your resident Dr Nitin gets a needlestick injury. What should be done? If he is documented fully immunized with post vaccination testing – nothing If he is documented fully immunized but without post vaccination testing – Single dose of vaccine Unvaccinated / partially vaccinated – HBIG & Hep B vaccine

58. While doing a procedure on an HBsAg + ve patient, your resident Dr Nitin gets a needlestick injury. What should be done? If he is documented fully immunized with post vaccination testing – nothing If he is documented fully immunized but without post vaccination testing – Single dose of vaccine Unvaccinated / partially vaccinated – HBIG & Hep B vaccine

59. Above what age would you use Hep B / Twinrix Adult dose 11 years 13 years 16 years 18 years

60. Above what age would you use Hep B / Twinrix Adult dose 11 years 13 years 16 years 18 years

61. Bhuvan is going abroad for higher studies in 1 month. He wants the Hep B vaccine. What schedule can we follow? There is only 1 recommended schedule for adults 0,1 & 6 months Accelerated schedule 0, 7, 21 days and then booster after 1 year Accelerated Schedule 0, 1, 2 month and booster after 1 year

62. Bhuvan is going abroad for higher studies in 1 month. He wants the Hep B vaccine. What schedule can we follow? There is only 1 recommended schedule for adults 0,1 & 6 months Accelerated schedule 0, 7, 21 days and then booster after 1 year Accelerated Schedule 0, 1, 2 month and booster after 1 year

63. When would NOT vaccinate a person with Hep B vaccine? HIV + ve Pregnancy Lactation None of the above

64. When would NOT vaccinate a person with Hep B vaccine? HIV + ve Pregnancy Lactation None of the above

65. The ideal Hep B vaccination schedule is ….

66. The ideal Hep B vaccination schedule is …. 0 – 1 – 6 months !