Biovac A, Live hepaptis A vaccination, talk in IAP Chennai Vaccine meet, Sept 2018. Long term data, single dose data, Indian studies and need for Hep A vaccine, also comparison with inactivated Hep A vaccines

1. Dr. Gaurav Gupta,
Charak Clinics, Mohali
For Chennai, 9th Sept 2018

2. Conflict of Interest
• Received grants from various vaccine
manufacturers including

3. Scope
 Is Hep A real problem in India?
 Does the Live Hep A vaccine really work?
 Does 1 dose work?
 How long does it protect?
 Recommendations

5.  What is the incubation period of Hep A?
 How long can Hep A last?
 How is the Live HAV administered?

11. As India shifts from __ to __ endemicity, burden of
symptomatic disease increases.
a. Low, High
b. High, Intermediate
c. Low, Intermediate
d. High, Low

12. HAV Epidemiological Study (Indian
Population)
Seroprevalence study of
Hepatitis A virus antibody in
Indian children (2011 – 2012)
Centres: Kolkata, Pune, Delhi &
Chennai
Population: 928 Children
Age group: 18 months to
10 years age

13. HAV Epidemiological Study (Indian
Population)
Conclusion:
• HAV prevalence increased
with Age,
• SEC, Education, Source of
drinking water,
• Pvt toilets (33 %) v/s Open
Fields (75 %)

14. Age gp 19981 20012 20123
1-5 yrs 56.4 52.2 26.05
6-10 yrs 77.5 62.2 49.64
All ages 78 66 37.5
Shift in Seroprevalence of Hep A in
India
1 Dhawan PS Indian J Gastro 1998;17:16-18
2 Mall ML Indian J Gastro 2001;20:132-35
3 Arankalle V et al. (2014). Vaccines: Development and Therapy Volume 2014:4 Pages 7 - 13

16.  How long does the protection from Hep A vaccine
last?
 Role of pre-vaccination screening before Hep A
vaccine?
 What is the time frame for starting Post Exposure
Prophylaxis?

23.  What is the peak infectious period of Hep A?
 How long can children excrete Hep A virus?
 Should a 15 yr old child weighing 72 kg receive
pediatric dose, but his 50 kg mother receive full dose?

31. HA Vaccine – Inactivated vs Live
Zheng H et al. Vacc. 2011;29:9098-9103
0
10
20
30
40
50
60
70
80
90
100
Day 7 Day 14 Day 28
Group A
[Live
Attenuat
ed H2]
Group C
[Inactiva
ted]
Sero-conversions at 7, 14 and 28 days,
hepatitis A vaccine Group A and C

37.  5 yr old comes with doubtful h/o Hep A Vaccine, what
will you do?
 11 yr old with h/o 1 dose of inactivated Hep A Vaccine
given 5 yr back, what is the course of action?
 What are the protective titer levels for Hep A?

39. Evaluation of Immunogenicity and Tolerability of a Live
attenuated Hepatitis A vaccine in Indian children – 2004
to 2014, Pune (n =121)
111.1
66.6
100.4
0
20
40
60
80
100
120
2004 2007 2010 2014
GMT(mIU/mL) *
* GMT of 2004 not presented as anti HAV
titres >100mIU/mL were not quantified in
2004
Bhave S. et al. J. Ind. Ped. 2015;52:687-690
95.8 92.3
77.7
87.6
0
25
50
75
100
2004 2007 2010 2014
Seroprotection(%)
Seroprotection Rate Geometric Mean Titers

40. Immunogenicity & Safety of Live attenuated
Hepatitis A Vaccine : Multicenter Study
 At trial was conducted New Delhi, Mumbai, Chennai, Kolkata
 505 Children, 18 – 60 mths age, Follow-up 5 years
95% 97.90% 98.30% 96.15% 97.80% 97.30%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
6 Wks 6 mos 1 yr 2 yr 3 yr 5 yr
Sero protection
81.4
150.6 150 156
144.6
127.1
0
20
40
60
80
100
120
140
160
180
6 Wks 6 mos 1 yr 2 yr 3 yr 5 yr
GMT (mlU/ml)
Faridi M MA et al. Hum. Vacc. Immunotherap. 2015; 11(5): 1147-1152

42. Immune memory at 17-years of follow-up of a single dose
of live attenuated hepatitis A vaccine
Ying Chen a,1, - Immune memory at 17-years of follow-up of a single dose of live attenuated hepatitis A vaccine (Vaccine – 2017)
• In anti-HAV positive group ~28 fold increase in GMC’s; In anti-HAV negative group ~83 fold increase in
GMC’s
• No significant difference in antibody titer between the two groups post-challenge

50. Take home message
 Live HA Vaccine provides both Humoral & CMI
 Same dose for Peds/ adults
 Single dose works -> Cost effective
 Only HA Vaccine backed with > 10 yr Indian data
 Proven long term protection with 17 year booster
challenge test, due to memory cells.

51. Call to Action!
 HAV is very common, and has high morbidity
(remember FHF)
 Routine vaccination is recommended
 Single dose Live HAV can be used as suggested by
WHO & IAP

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Acknowledgements:
Dr. Archana, Medical Advisor Wockhardt
Dr. Shrish Bhatnagar, Ped Gastro, Lucknow