polio research activities in india dr sunil bahl who-india, npsp 15 march 2012
DESCRIPTION
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 monthsTRANSCRIPT
Polio Research Activities in India
Dr Sunil BahlWHO-India, NPSP
15 March 2012
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
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
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
Seroprevalence (6-11 month infants) – UP, Bihar: 2011
Type 1 Type 2 Type 3Percent
seropositive
Median SIA doses
Median RI doses
7 7
2
8
3 3
Seroprevalence in different age groups – UP, Bihar: 2011
6-7 months 8-9 months 10-11 monthsPercent seropositive
> 0.05 < 0.05 < 0.05p value
Comparative seroprevalence in 6-7 month infants : 2011 vs 2010 High Risk Blocks - UP & Bihar
2010 2011
Percent seropositive
p value < 0.01 < 0.01> 0.05
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
Ten study sites for mucosal immunity study-Moradabad
Mucosal immunity study - study populationArm A: bOPV
6-11 mthsN=110
5 yearsN=110
10 yearsN=110
Arm B: IPV
6-11 mthsN=110
5 yearsN=110
10 yearsN=110
Arm C: No Vaccine (Control arm)
6-11 mthsN=110
5 yearsN=110
10 yearsN=110
•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
Mucosal immunity study - Study Design
BloodStool
Crevicular fluid
Arm A:bOPV
Arm B:IPV
Arm C:No
Vaccine(Control
arm)
Day 0
Blood
Day 7
BloodStool
Crevicular fluid
Day 28
Stool
Day 28+3
Stool
Day 28+7
Stool
Day 28+14
BloodCrevicular fluid
Day 56
bOPV Challenge to children in all arms
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
Proposed Polio Research Activities in India : 2012-2013
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
switch4. Pilot to assess feasibility of IPV
administration in a mass campaign5. Assess social determinants of vaccine
refusals (survey for social networking analysis)
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
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
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
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
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
Question for the IEAG
Are the studies/surveys proposed in line with current programme needs in India?
Thank You