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

Primary Purpose

Poliomyelitis, Tropical Enteropathy

Status

Completed

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

IPV vaccination

About this trial

This is an interventional basic science trial for Poliomyelitis focused on measuring Oral vaccines, Vaccine Responsiveness, Tropical Enteropathy

Eligibility Criteria

42 Days - 49 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

National Institute of Cholera and Enteric Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IPV vaccination

OPV vaccination

Arm Description

Randomized IPV vaccination to children at the age of 39 weeks.

Randomized OPV vaccination to children at the age of 39 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).

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).

Full Information

NCT ID

NCT01571505

First Posted

March 28, 2012

Last Updated

August 30, 2017

Sponsor

International Vaccine Institute

Collaborators

Bill and Melinda Gates Foundation, National Institute of Cholera and Enteric Diseases, India, University of Virginia, University of Vermont

1. Study Identification

Unique Protocol Identification Number

NCT01571505

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

March 1, 2012 (Actual)

Primary Completion Date

November 30, 2016 (Actual)

Study Completion Date

November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International Vaccine Institute

Collaborators

Bill and Melinda Gates Foundation, National Institute of Cholera and Enteric Diseases, India, University of Virginia, University of Vermont

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis, Tropical Enteropathy

Keywords

Oral vaccines, Vaccine Responsiveness, Tropical Enteropathy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

372 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IPV vaccination

Arm Type

Experimental

Arm Description

Randomized IPV vaccination to children at the age of 39 weeks.

Arm Title

OPV vaccination

Arm Type

Placebo Comparator

Arm Description

Randomized OPV vaccination to children at the age of 39 weeks.

Intervention Type

Biological

Intervention Name(s)

IPV vaccination

Other Intervention Name(s)

Rotavirus vaccination to children at 10 and 17 weeks of age.

Intervention Description

Randomized IPV or OPV to children aged at 39weeks.

Primary Outcome Measure Information:

Title

Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.

Description

Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.

Time Frame

Birth to one year

Secondary Outcome Measure Information:

Title

Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).

Time Frame

Birth to one year

Title

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).

Time Frame

Birth to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

42 Days

Maximum Age & Unit of Time

49 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: