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

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571505
• Other study ID #: POLIO ROTA-02
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2012
• Last updated: August 30, 2017
• Start date: March 1, 2012
• Est. completion date: November 30, 2016

Study information

• Verified date: August 2017
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 49 Days

Eligibility

Inclusion Criteria:

1. Mother willing to sign informed consent form.

2. Infant aged 0 to 49 days old.

3. No obvious congenital abnormalities or birth defects.

Exclusion Criteria:

1. Parents are not willing to have child's blood drawn.

2. Parents are planning to enroll child into another clinical study during the time period of this trial.

3. Mother not willing to have blood drawn and breast milk extracted.

4. Parents not willing to have field research assistant in home.

5. History of seizures or other apparent neurologic disorders.

6. Infant does not have proof of BCG and OPV since birth by immunization card.

7. History of acute illness and/or immunocompromised state of the child.

8. Immunocompromised or chronically ill mother

Related Conditions & MeSH terms

• Intestinal Diseases
• Poliomyelitis
• Tropical Enteropathy

Intervention

Biological:
• IPV vaccination
Randomized IPV or OPV to children aged at 39weeks.

Locations

Country	Name	City	State
India	National Institute of Cholera and Enteric Diseases	Kolkata

Sponsors (5)

Lead Sponsor	Collaborator
International Vaccine Institute	Bill and Melinda Gates Foundation, National Institute of Cholera and Enteric Diseases, India, University of Vermont, University of Virginia

Country where clinical trial is conducted

India, 

References & Publications (1)

Kanungo S, Kim DR, Haldar B, Snider C, Nalavade U, Kim SA, Park JY, Sinha A, Mallick AH, Manna B, Sur D, Nandy RK, Deshpande JM, Czerkinsky C, Wierzba TF, Petri WA Jr, Ali M, Dey A. Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Ind — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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