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Polio Research Activities in India

Polio Research Activities in India. Dr Sunil Bahl WHO-India, NPSP 15 March 2012. IEAG recommendations and follow up actions. Recommendations of IEAG (July 2011): Seroprevalence study in UP-Bihar

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Polio Research Activities in India

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  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 Bihar Western UP 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 3 Type 1 Type 2 Percent seropositive 8 7 Median SIA doses 7 3 Median RI doses 2 3 7

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

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

  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 • 110 children of three age groups in each arm • Total sample size: • 110 children x 3 age groups x 3 study arms (990 children)

  11. Mucosal immunity study - Study Design 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 • Seroprevalence study in Western UP & Bihar • Assess different bOPV products • Assess strategies for a safe tOPV-bOPV switch • Pilot to assess feasibility of IPV administration in a mass campaign • 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

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