Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)

Study Overview
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Brief Summary
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Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.

Detailed Description
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Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.

Official Title
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Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA

Conditions
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Poliomyelitis, Tropical Enteropathy

Intervention / Treatment
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* Biological: IPV vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mother willing to sign informed consent form. Infant aged 0 to 49 days old. No obvious congenital abnormalities or birth defects. Exclusion Criteria: Parents are not willing to have child's blood drawn. Parents are planning to enroll child into another clinical study during the time period of this trial. Mother not willing to have blood drawn and breast milk extracted. Parents not willing to have field research assistant in home. History of seizures or other apparent neurologic disorders. Infant does not have proof of BCG and OPV since birth by immunization card. History of acute illness and/or immunocompromised state of the child. Immunocompromised or chronically ill mother

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 49 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPV vaccination<br>Randomized IPV vaccination to children at the age of 39 weeks. | Biological: IPV vaccination<br>* Randomized IPV or OPV to children aged at 39weeks.<br>* Other names: Rotavirus vaccination to children at 10 and 17 weeks of age.;|
| Placebo Comparator: OPV vaccination<br>Randomized OPV vaccination to children at the age of 39 weeks. | Biological: IPV vaccination<br>* Randomized IPV or OPV to children aged at 39weeks.<br>* Other names: Rotavirus vaccination to children at 10 and 17 weeks of age.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine. | Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio. | Birth to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV). |  | Birth to one year | 
| Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV). |  | Birth to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral vaccines, Vaccine Responsiveness, Tropical Enteropathy