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

Phase 3

Completed

• Conditions: Rotavirus Diarrhea; Vaccine Virus Shedding; Tropical Enteropathy
• Interventions: Biological: Rotarix; Biological: IPV

• Registration Number: NCT01375647
• Lead Sponsor: University of Vermont

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 breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.

Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.

Secondary Objectives: 1) to determine the impact of an inactivated polio vaccine (IPV) boost on the efficacy of oral polio vaccine and 2) to determine the efficacy of oral rotavirus vaccine to prevent rotavirus diarrhea

The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-17
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Mother willing to sign informed consent form.
2. Healthy infant aged 0 to 7 days old.
3. No obvious congenital abnormalities or birth defects.
4. No abnormal (frequency and consistency) stools since birth.
5. Stable household with no plans to leave the area for the next one year.

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Exclusion Criteria

1. Parents are not willing to have child vaccinated at the field clinic.
2. Parents are not willing to have child's blood drawn.
3. Parents are planning to enroll child into another clinical study during the time period of this trial.
4. Mother not willing to have blood drawn and breast milk extracted.
5. Parents not willing to have field research assistant in home two times per week.
6. History of seizures or other apparent neurologic disorders.
7. Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
8. Infant has any sibling currently or previously enrolled in this study, including a twin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Rotarix + No IPV	Rotarix	Randomized to receive rotarix vaccine but no IPV boost
Rotarix + with IPV boost	IPV	Randomized to receive both rotarix vaccine and IPV boost
Rotarix + with IPV boost	Rotarix	Randomized to receive both rotarix vaccine and IPV boost
No Rotarix + with IPV boost	IPV	Randomized to receive no rotarix vaccine but to receive IPV boost

Primary Outcome Measures

Name	Time	Method
One or more episodes of rotavirus-associated diarrhea (rotavirus trial)	Birth to one year
Presence of fecal shedding of polio vaccine virus determined by culture (polio trial)	25 days following week 52 visit

Secondary Outcome Measures

Name	Time	Method
Serum neutralizing antibody response (polio trial)	40 weeks and 53 weeks
Community fecal shedding of polio vaccine virus just prior to one year OPV dose (polio trial)	52 weeks
Duration of fecal shedding of polio vaccine virus (polio trial)	25 days following week 52 visit
Total duration of rotavirus-associated diarrheal episodes (rotavirus trial)	Birth to one year
Total number of diarrheal episodes (rotavirus trial)	Birth to one year
Presence and duration of fecal polio virus shedding within the three individual virus strains (polio trial)	25 days following week 52 visit

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh