Not Yet RecruitingPhase 4ACTRN12612000259842

Immune response to polio vaccine in malnourished and normally nourished Pakistani infants

Immunogenicity of Combined Bivalent OPV and IPV Vaccines at 9 - 12 months of Age Compared to bOPV alone in Malnourished and Non-Malnourished Pakistani Infants, Aga Khan University, Karachi Pakistan

Sponsor

WHO

Enrollment

840 participants

Start Date

Apr 15, 2012

Study Type

Interventional

Conditions

polio vaccine immunogenecity

Summary

Because of the questionable immunogenicity of OPV in moderate to severe chronically malnourished children in a country which is having a hard time ensuring each and every child receives more than 7 doses of OPV, a transitional strategy comprising of OPV and inactivated poliovirus vaccine (IPV) may be effective in boosting intestinal and serological immunity in selected high risk populations such as in areas with a high proportion of moderate to severe chronically malnourished children. There is limited evidence to show if OPV and IPV given together results in a sufficient antigenic load to induce enhanced immunogenicity (intestinal and serological) in moderate to severe chronically malnourished children.

Eligibility

Sex: Both males and femalesMin Age: 9 MonthssMax Age: 12 Monthss

Inclusion Criteria4

Infant aged 9 - 12 months of age
Resident of the study area for last 3 month at the time of enrolment
Parent/guardian provides informed consent
Nutritional status will be assessed; chronically malnourished children and normally nourished children will be assigned to different study arms

Exclusion Criteria7

Infant already enrolled in any other polio intervention study.
Allergic to antibiotics neomycin, streptomycin or polymyxin B (as these antibiotics are the component of IPV and may lead to severe life-threatening events)
Infant found acutely ill at the time of enrolment, requiring emergent medical care
Infant with moderate and severe acute malnutrition, defined by a very low weight for height (below -2z and -3z scores of the median WHO growth standards respectively).
Refusal of blood testing
Receipt of supplementary dose of OPV within 4 weeks of first study visit
Infant with certain medical conditions i.e., cerebral palsy, syndromic infants, infants on corticosteroids because of any medical illness, thrombocytopenia (contraindication of intramuscular injections), malignancies and infant with primary immunodeficiency

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Interventions

inactivated (injectable) polio vaccine (0.5 ml) together with bivalent oral polio vaccine (two drops) administered once to malnourished and normally nourished children between 9-12 months of age ch

inactivated (injectable) polio vaccine (0.5 ml) together with bivalent oral polio vaccine (two drops) administered once to malnourished and normally nourished children between 9-12 months of age challenge dose with bivalent oral polio vaccine (two drops) administered one month post initial vaccine administration

Locations(1)

Pakistan

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ACTRN12612000259842