1. Polio Research Activities in India Dr Sunil Bahl WHO-India, NPSP 15 March 2012

2. IEAG recommendations and follow up actions Recommendations of IEAG (July 2011): –Seroprevalence study in UP-Bihar –Accelerate research & product development agenda (e.g. mucosal immunity, mathematical modelling, safe & affordable IPV approaches) Studies completed during 2011 –Seroprevalence study in UP & Bihar –Mucosal immunity study in Moradabad

3. Seroprevalence study, UP & Bihar-August 2011 Objectives of study: –Assess seroprevalence to all poliovirus types –Compare seroprevalence of 2011 with 2010 –Compare seroprevalence among three age sub- groups Study age groups: 6-7, 8-9 and 10-11 months

4. 10 high risk blocks each in West UP and Bihar Western UP Bihar 20 children from each of 3 age groups in each block Sample Size: 600 (UP) + 600 (Bihar) = 1200

5. Seroprevalence (6-11 month infants) – UP, Bihar: 2011 Type 1Type 2 Type 3 Percent seropositive Median SIA doses Median RI doses 7 7 2 7 8 3 3

6. Seroprevalence in different age groups – UP, Bihar: 2011 6-7 months 8-9 months 10-11 months Percent seropositive > 0.05< 0.05 p value

7. Comparative seroprevalence in 6-7 month infants : 2011 vs 2010 High Risk Blocks - UP & Bihar 20102011 Percent seropositive p value < 0.01 > 0.05

8. Mucosal immunity study-Moradabad, Oct to Dec 2011 Key Objectives: Assess baseline mucosal immunity & if there is waning of mucosal immunity in older age groups Evaluate which polio vaccine (IPV or bOPV) is more efficient in boosting mucosal immunity Assess correlations between humoral and mucosal immunity in different age groups

9. Ten study sites for mucosal immunity study-Moradabad

10. Mucosal immunity study - study population Study subjects distributed into three study arms Total sample size: 110 children x 3 age groups x 3 study arms (990 children) 110 children of three age groups in each arm

11. Mucosal immunity study - Study Design Blood Stool Crevicular fluid Arm A: bOPV Arm B: IPV Arm C: No Vaccine (Control arm) Day 0 Blood Day 7 Blood Stool Crevicular fluid Day 28 Stool Day 28+3 Stool Day 28+7 Stool Day 28+14 Blood Crevicular fluid Day 56 bOPV Challenge to children in all arms

12. Mucosal immunity study- status Field implementation completed in December 2011 989 subjects enrolled 948 (96%) enrolled subjects completed study for all samples Samples collected –Stool samples: 4871 –Blood samples: 2935 –Crevicular fluid samples: 1966 Testing of samples ongoing in ERC Mumbai Aliquot of samples being sent to CDC, Atlanta

13. Proposed Polio Research Activities in India : 2012-2013

14. Research activities proposed, 2012-2013 1.Seroprevalence study in Western UP & Bihar 2.Assess different bOPV products 3.Assess strategies for a safe tOPV-bOPV switch 4.Pilot to assess feasibility of IPV administration in a mass campaign 5.Assess social determinants of vaccine refusals (survey for social networking analysis)

15. Seroprevalence study, UP & Bihar 2012 Objectives: –Assess seroprevalence to all poliovirus types & compare levels with previous years –Compare seroprevalence between HR and non- HR blocks Similar design as in 2011 except: include 5 High Risk (HR) blocks and 5 adjoining non- HR blocks (instead of 10 HR blocks) Age group 6-11 months

16. bOPV assessment study Generate data on immunogenicity and safety of additional bOPV products for potential licensing by national regulatory authority (DCGI) in India Demonstrate superiority of 2 doses of bOPV of different manufacturers over tOPV for seroconversion to types 1 and 3 Additional options for bOPV supply to meet high vaccine requirement in India & globally – important specially for the endgame strategy

17. Study to facilitate tOPV-bOPV switch under EPI Compare immunogenicity against poliovirus types 1 and 3 by bOPV & tOPV given as part of routine EPI schedule Assess gain in immunity (booster effect) of a full dose or fractional dose of IPV when added to tOPV or bOPV at 14 weeks (DPT3 contact) in EPI schedule Assess operational feasibility of intra-dermal IPV fractional dose using BCG syringe

18. Pilot administration of IPV in mass campaigns Assess –operational & communication challenges –coverage achieved –safety Co-administration of IPV & OPV at fixed sites/ house- to-house/in the street during campaign Pilot in 3 blocks of a Western UP district –Block 1: OPV + IPV full dose given IM using conventional syringe –Block 2: OPV + IPV fractional dose given ID using needle free device –Block 3: Only OPV

19. Survey for social network analysis Areas of significance resistance/refusal to polio or other vaccines persist: e.g. Malegaon, West Bengal etc. Assessment of community acceptance/refusal behaviour for polio and other vaccines Examine whether social connections to individuals with specific socio-demographic attributes are related to refusals Determine the extent to which non-compliant households in an area are connected and influence each other Identify how to leverage social networks for promoting polio vaccine compliance

20. Question for the IEAG Are the studies/surveys proposed in line with current programme needs in India? Thank You