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Hep B vaccine - Ideal Schedule. Also quiz on Hep B vaccination
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HEP B VACCINE – MOST EFFECTIVE SCHEDULE
(& A QUIZ!)Dr Gaurav Gupta
MAAP, MIAPAuthor of ‘Clippings’ in Indian Pediatrics since 2002
www.charakclinics.com
SAVE – Goa, 20th April, 2013
Conflict of Interest
Received grants from various vaccine manufacturers including - Sanofi Pasteur- GSK- MSD- Pfizer etc.
Scope
Why do we need vaccination for Hep B? What is an ideal vaccination schedule? Quiz !
Dr. Gaurav Gupta, Charak Care Clinics, Mohali
Leading Causes of Infectious DiseaseDeaths Worldwide
DiseaseLower respiratory tract infectionsDiarrheal diseasesHIV/AIDSTuberculosisHepatitis virusesHepatitis B virusHepatitis C virusMalaria PertussisNeonatal tetanusMeasles
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
Geographic distribution of chronic hepatitis B virus (HBV) infection — worldwide, 2006*
High (>8%): 45% of global populationlifetime risk of infection >60%early childhood infections common
Intermediate (2%-7%): 43% of global populationlifetime risk of infection 20%-60%infections occur in all age groups
Low (<2%): 12% of global populationlifetime risk of infection <20%most infections occur in adult risk groups
Global Pattern of Chronic HBV Infection
Problem statementINDIA: 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
HBsAg
HBcAg
HBeAg
Hepatitis B Virus
EXPOSURE
Acute hepatitis B infection
AsymptomaticOr
Subclinical infection
Clinical infection-jaundice-flu like symptom
Fulminant hepatitis
Death
ChronicCarrier
RecoveryOr
Immunity
Minimal liver
Disease
Chronic Hepatitis
Primary hepatocellular
carcinomacirrhosis
DEATH
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
0
10
20
30
40
50
60
70
80
90
100
Birth 1-6 mo 7-12 mo 1-4 yrs 5+ yrs
Age of infection
Ca
rrie
r ri
sk
(%
)Risk of Chronic HBV Carriage by
Age of Infection
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
THE BEST PREVENTIVE METHOD IS
VACCINATION
Hepatitis B
Success of Hepatitis B vaccine
18
Mechanism of Long-Term Protectionwith Hepatitis B Vaccine
Primary vaccination series
Immune memory
Anamnestic antibody response
Rapid rise in anti-HBs
Protection from infection
Exposure to HBV
19
Serologic Response to Booster Dose ofHepatitis B Vaccine
1
10
100
1000
10000
0 6 12 18 24 30 36 42 48 54 60 66 72 78 84
Age (months)
GM
T A
nti-
HB
s (m
IU/m
l)
Primaryseries
Booster dose (simulating natural infection)
Source: Williams and Goldstein, CDC
2 weeks post-booster 4 weeks post-booster
1 yearpost-booster
20
Long-Term Protection withHepatitis B Vaccine
· Vaccine provides long-term protection· Immunity persists despite loss of anti-HBs
- documented protection up to 15 years lifelong protection likelycontinued follow-up needed to determine duration
of protection
Booster doses of hepatitis B vaccine NOT currently recommended
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?
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 1st
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 2nd & 3rd dose increases Ab titres
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.
Importance of vaccination schedule at 0-1-6 mo/o vs 2-4-6 mo/o.
Group 1Hep.B at 0-1-6
Group 2Hep.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
Importance of vaccination schedule at 0-1-6 mo/o vs 2-4-6 mo/o.
Group 1Hep.B at 0-1-6
Group 2Hep.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
749.12
23.44 79.70
6375.86
84.3941.70
1000
2000
3000
4000
5000
6000
7000
After 1st dose After 2nd dose After 3rd dose
GMT (mIU/ml)
GM
T (
mIU
/ml)
GMT (mIU/ml) 0,1,2 schedule
GMT (mIU/ml) 0,1,6 schedule
Ab titres (ShanvacB) with 0-1-2 & 0-1-6 schedules
GMT in infant vaccinated against Hepatitis B by different vaccination schedules
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
International Schedules
Majority of schedules begin at birth
Most end at 6 months age or more
Gap of at least 8 weeks between 2nd and 3rd doses
If the gap is less, then a 4th dose given
Majority have monovalent Hep B vaccine
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
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
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.
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?
a) Within 12 hours only
b) Within 24 hours
c) Within 48 hours
d) Within 7 days
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?
a) Within 12 hours only
b) Within 24 hours
c) Within 48 hours
d) Within 7 days
Anoushka also wants to know if she can Breastfeed the baby?
a) No, top feed only
b) BF after completing 3 doses of vaccine
c) BF from birth
d) BF only if received HBIG
Anoushka also wants to know if she can Breastfeed the baby?
a) No, top feed only
b) BF after completing 3 doses of vaccine
c) BF from birth
d) BF only if received HBIG
When should this baby (of Anoushka) be tested for Hep B disease?
a) At birth
b) At 3 months
c) At 6 months
d) At 9 months
When should this baby (of Anoushka) be tested for Hep B disease?
a) At birth
b) At 3 months
c) At 6 months
d) At 9 months
How soon after taking Hep B vaccine can someone donate blood?
a) Immediately, there is no C/I
b) 1 month
c) 3 months
d) 6 months
How soon after taking Hep B vaccine can someone donate blood?
a) Immediately, there is no C/I
b) 1 month
c) 3 months
d) 6 months
(Similarly draw blood for testing before vaccination with Hep B vaccine)
After seeing this excellent presentation you want to know if you are really protected against Hep B. What should you do?
a) You have taken 3 doses, you are obviously protected
b) Do an anti-HBs immediately.
c) Do an HBsAg immediately
d) You need to take 1 dose & then test for anti-HBs
e) You need to take all 3 doses again & then test for anti-HBs
After seeing this excellent presentation you want to know if you are really protected against Hep B. What should you do?
a) You have taken 3 doses, you are obviously protected
b) Do an anti-HBs immediately.
c) Do an HBsAg immediately
d) You need to take 1 dose & then test for anti-HBs
e) You need to take all 3 doses again & then test for anti-HBs
Who all should be tested for antibodies after Hep B vaccination?
a) Everyone
b) Immunodeficient & Hemodialysis cases
c) Health care workers dealing with blood & blood products
d) Infants of HBsAg +ve mother
e) Family members of HBsAg +ve person
Who all should be tested for antibodies after Hep B vaccination?
a) Everyone
b) Immunodeficient & Hemodialysis cases
c) Health care workers dealing with blood & blood products
d) Infants of HBsAg +ve mother
e) Family members of HBsAg +ve person
What is the protective levels of anti-HBs for preventing Hep B disease?
a) 0.1 mIU/ml
b) 1 mIU/ml
c) 10 mIU/ml
d) 100 mIU/ml
What is the protective levels of anti-HBs for preventing Hep B disease?
a) 0.1 mIU/ml
b) 1 mIU/ml
c) 10 mIU/ml
d) 100 mIU/ml
You have been tested 2 months after completing a course of Hep B vaccination, and your titres are below 10, what should be done?
a) Nothing can be done, you will remain susceptible
b) Do an HBsAg t/r/o HBV infection
c) Repeat another course, and if your titres remain low, then you will be susceptible
d) If the second course fails, try ID Hep B Vaccine
e) If the second course fails, try a course of double dose Twinrix
You have been tested 2 months after completing a course of Hep B vaccination, and your titres are below 10, what should be done?
a) Nothing can be done, you will remain susceptible
b) Do an HBsAg t/r/o HBV infection
c) Repeat another course, and if your titres remain low, then you will be susceptible
d) If the second course fails, try ID Hep B Vaccine
e) If the second course fails, try a course of double dose Twinrix
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?
a) No need for tests & no booster – you are protected for life
b) Tested every year, booster if level below 10
c) Tested every 5 years, booster as above
d) Tested every 10 years, booster as above
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?
a) No need for tests & no booster – you are protected for life
b) Tested every year, booster if level below 10
c) Tested every 5 years, booster as above
d) Tested every 10 years, booster as above
In which patients would you consider repeated testing of anti-HBs Ab?
a) In doctors
b) In patients with chronic liver disease
c) In patients of CRF
d) In HIV +ve & immunocompromised children
In which patients would you consider repeated testing of anti-HBs Ab?
a) In doctors
b) In patients with chronic liver disease
c) In patients of CRF
d) In HIV +ve & immunocompromised children
Your staff has accidentally put the Hep B vaccine in the freezer compartment & it is now frozen. What should you do?
a) It has to be discarded
b) Thaw it gently and reuse once it is completely liquid again
c) Use it as a combination vaccine with DPT + Hib
Your staff has accidentally put the Hep B vaccine in the freezer compartment & it is now frozen. What should you do?
a) It has to be discarded
b) Thaw it gently and reuse once it is completely liquid again
c) Use it as a combination vaccine with DPT + Hib
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?
a) Ask her to go back to the same doctor
b) Buy the same brand and give to the child by calling it again after a few days
c) Use whatever brand is available with you
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?
a) Ask her to go back to the same doctor
b) Buy the same brand and give to the child by calling it again after a few days
c) Use whatever brand is available with you
While doing a procedure on a patient of unknown HBsAg status, your resident Dr Nitin gets a needlestick injury. What should be done?
a) If he is documented fully immunized – nothing
b) Documented fully immunized – 1 dose of Hep B vaccine
c) Unvaccinated / partially vaccinated –Hep B vaccine as per schedule immediately
d) Unvaccinated/ partially vaccinated – Hep B vaccine + HBIG immediately
While doing a procedure on a patient of unknown HBsAg status, your resident Dr Nitin gets a needlestick injury. What should be done?
a) If he is documented fully immunized – nothing
b) Documented fully immunized – 1 dose of Hep B vaccine
c) Unvaccinated / partially vaccinated –Hep B vaccine as per schedule immediately
d) Unvaccinated/ partially vaccinated – Hep B vaccine + HBIG immediately
While doing a procedure on an HBsAg +ve patient, your resident Dr Nitin gets a needlestick injury. What should be done?
a) If he is documented fully immunized with post vaccination testing – nothing
b) If he is documented fully immunized but without post vaccination testing – Single dose of vaccine
c) Unvaccinated / partially vaccinated – HBIG & Hep B vaccine
While doing a procedure on an HBsAg +ve patient, your resident Dr Nitin gets a needlestick injury. What should be done?
a) If he is documented fully immunized with post vaccination testing – nothing
b) If he is documented fully immunized but without post vaccination testing – Single dose of vaccine
c) Unvaccinated / partially vaccinated – HBIG & Hep B vaccine
Above what age would you use Hep B / Twinrix Adult dose
a) 11 years
b) 13 years
c) 16 years
d) 18 years
Above what age would you use Hep B / Twinrix Adult dose
a) 11 years
b) 13 years
c) 16 years
d) 18 years
Bhuvan is going abroad for higher studies in 1 month. He wants the Hep B vaccine. What schedule can we follow?
a) There is only 1 recommended schedule for adults 0,1 & 6 months
b) Accelerated schedule 0, 7, 21 days and then booster after 1 year
c) Accelerated Schedule 0, 1, 2 month and booster after 1 year
Bhuvan is going abroad for higher studies in 1 month. He wants the Hep B vaccine. What schedule can we follow?
a) There is only 1 recommended schedule for adults 0,1 & 6 months
b) Accelerated schedule 0, 7, 21 days and then booster after 1 year
c) Accelerated Schedule 0, 1, 2 month and booster after 1 year
When would NOT vaccinate a person with Hep B vaccine?
a) HIV +ve
b) Pregnancy
c) Lactation
d) None of the above
When would NOT vaccinate a person with Hep B vaccine?
a) HIV +ve
b) Pregnancy
c) Lactation
d) None of the above
The ideal Hep B vaccination schedule is ….
The ideal Hep B vaccination schedule is ….
0 – 1 – 6 months !