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

Vaccine Virus Shedding Clinical Trial

— PROVIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375647
• Other study ID #: PROVIDE
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2011
• Last updated: April 13, 2015
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: University of Vermont
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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.

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.

Related Conditions & MeSH terms

• Diarrhea
• Intestinal Diseases
• Rotavirus Diarrhea
• Tropical Enteropathy
• Vaccine Virus Shedding

Intervention

Biological:
• IPV
Administered per protocol
• Rotarix
Administered per protocol

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (7)

Lead Sponsor	Collaborator
University of Vermont	Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, International Centre for Diarrhoeal Disease Research, Bangladesh, Stanford University, University of Virginia, Washington University School of Medicine

Country where clinical trial is conducted

Bangladesh, 

References & Publications (1)

Kirkpatrick BD, Colgate ER, Mychaleckyj JC, Haque R, Dickson DM, Carmolli MP, Nayak U, Taniuchi M, Naylor C, Qadri F, Ma JZ, Alam M, Walsh MC, Diehl SA; PROVIDE Study Teams, Petri WA Jr. The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems. Am J Trop Med Hyg. 2015 Apr;92(4):744-51. doi: 10.4269/ajtmh.14-0518. Epub 2015 Feb 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of fecal shedding of polio vaccine virus determined by culture (polio trial)		25 days following week 52 visit
Primary	One or more episodes of rotavirus-associated diarrhea (rotavirus trial)		Birth to one year
Secondary	Duration of fecal shedding of polio vaccine virus (polio trial)		25 days following week 52 visit
Secondary	Community fecal shedding of polio vaccine virus just prior to one year OPV dose (polio trial)		52 weeks
Secondary	Presence and duration of fecal polio virus shedding within the three individual virus strains (polio trial)		25 days following week 52 visit
Secondary	Serum neutralizing antibody response (polio trial)		40 weeks and 53 weeks
Secondary	Total number of diarrheal episodes (rotavirus trial)		Birth to one year
Secondary	Total duration of rotavirus-associated diarrheal episodes (rotavirus trial)		Birth to one year