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

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ClinicalTrials.gov Identifier: NCT01375647

Recruitment Status : Completed

First Posted : June 17, 2011

Last Update Posted : April 14, 2015

Sponsor:

Collaborators:

Bill and Melinda Gates Foundation

University of Virginia

International Centre for Diarrhoeal Disease Research, Bangladesh

Washington University School of Medicine

Stanford University

Centers for Disease Control and Prevention

Information provided by (Responsible Party):

Beth Kirkpatrick, University of Vermont

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 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.

Condition or disease	Intervention/treatment	Phase
Rotavirus Diarrhea Vaccine Virus Shedding Tropical Enteropathy	Biological: IPV Biological: Rotarix	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	700 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Study Start Date :	May 2011
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Polio and Post-Polio Syndrome

Drug Information available for: RIX4414 vaccine

Genetic and Rare Diseases Information Center resources: Poliomyelitis Tropical Sprue

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Rotarix + No IPV Randomized to receive rotarix vaccine but no IPV boost	Biological: Rotarix Administered per protocol
Experimental: Rotarix + with IPV boost Randomized to receive both rotarix vaccine and IPV boost	Biological: IPV Administered per protocol Biological: Rotarix Administered per protocol
No Intervention: No Rotarix + No IPV Randomized to receive neither rotarix vaccine nor IPV boost
Experimental: No Rotarix + with IPV boost Randomized to receive no rotarix vaccine but to receive IPV boost	Biological: IPV Administered per protocol

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	up to 7 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Parents are not willing to have child vaccinated at the field clinic.
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 two times per week.
History of seizures or other apparent neurologic disorders.
Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
Infant has any sibling currently or previously enrolled in this study, including a twin.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375647

Locations

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Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh

Sponsors and Collaborators

University of Vermont

Bill and Melinda Gates Foundation

University of Virginia

International Centre for Diarrhoeal Disease Research, Bangladesh

Washington University School of Medicine

Stanford University

Centers for Disease Control and Prevention

Investigators

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Principal Investigator:	Beth Kirkpatrick, M.D.	University of Vermont
Principal Investigator:	William Petri, M.D., Ph.D.	University of Virginia School of Medicine
Principal Investigator:	Rashidul Haque, M.D., Ph.D.	International Center for Diarrhoeal Disease Research, Bangladesh

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lin Y, Zhou J, Kumar S, Xie W, G Jensen SK, Haque R, Nelson CA, Petri WA Jr, Ma JZ. Group penalized generalized estimating equation for correlated event-related potentials and biomarker selection. BMC Med Res Methodol. 2020 Aug 31;20(1):221. doi: 10.1186/s12874-020-01103-x.

Rogawski ET, Platts-Mills JA, Colgate ER, Haque R, Zaman K, Petri WA, Kirkpatrick BD. Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study. J Infect Dis. 2018 Mar 5;217(6):861-868. doi: 10.1093/infdis/jix668.

Lee B, Carmolli M, Dickson DM, Colgate ER, Diehl SA, Uddin MI, Islam S, Hossain M, Rafique TA, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, McNeal MM, Petri WA, Qadri F, Haque R, Kirkpatrick BD. Rotavirus-Specific Immunoglobulin A Responses Are Impaired and Serve as a Suboptimal Correlate of Protection Among Infants in Bangladesh. Clin Infect Dis. 2018 Jul 2;67(2):186-192. doi: 10.1093/cid/ciy076.

Lee B, Dickson DM, deCamp AC, Ross Colgate E, Diehl SA, Uddin MI, Sharmin S, Islam S, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, Taniuchi M, Petri WA Jr, Haque R, Qadri F, Kirkpatrick BD. Histo-Blood Group Antigen Phenotype Determines Susceptibility to Genotype-Specific Rotavirus Infections and Impacts Measures of Rotavirus Vaccine Efficacy. J Infect Dis. 2018 Apr 11;217(9):1399-1407. doi: 10.1093/infdis/jiy054. Erratum in: J Infect Dis. 2018 Jun 5;218(1):171-172.

Upfill-Brown A, Taniuchi M, Platts-Mills JA, Kirkpatrick B, Burgess SL, Oberste MS, Weldon W, Houpt E, Haque R, Zaman K, Petri WA Jr. Nonspecific Effects of Oral Polio Vaccine on Diarrheal Burden and Etiology Among Bangladeshi Infants. Clin Infect Dis. 2017 Aug 1;65(3):414-419. doi: 10.1093/cid/cix354.

Lu M, Zhou J, Naylor C, Kirkpatrick BD, Haque R, Petri WA Jr, Ma JZ. Application of penalized linear regression methods to the selection of environmental enteropathy biomarkers. Biomark Res. 2017 Mar 9;5:9. doi: 10.1186/s40364-017-0089-4. eCollection 2017.

Colgate ER, Haque R, Dickson DM, Carmolli MP, Mychaleckyj JC, Nayak U, Qadri F, Alam M, Walsh MC, Diehl SA, Zaman K, Petri WA, Kirkpatrick BD. Delayed Dosing of Oral Rotavirus Vaccine Demonstrates Decreased Risk of Rotavirus Gastroenteritis Associated With Serum Zinc: A Randomized Controlled Trial. Clin Infect Dis. 2016 Sep 1;63(5):634-41. doi: 10.1093/cid/ciw346. Epub 2016 May 23.

Taniuchi M, Platts-Mills JA, Begum S, Uddin MJ, Sobuz SU, Liu J, Kirkpatrick BD, Colgate ER, Carmolli MP, Dickson DM, Nayak U, Haque R, Petri WA Jr, Houpt ER. Impact of enterovirus and other enteric pathogens on oral polio and rotavirus vaccine performance in Bangladeshi infants. Vaccine. 2016 Jun 8;34(27):3068-3075. doi: 10.1016/j.vaccine.2016.04.080. Epub 2016 May 3.

Naylor C, Lu M, Haque R, Mondal D, Buonomo E, Nayak U, Mychaleckyj JC, Kirkpatrick B, Colgate R, Carmolli M, Dickson D, van der Klis F, Weldon W, Steven Oberste M; PROVIDE study teams, Ma JZ, Petri WA Jr. Environmental Enteropathy, Oral Vaccine Failure and Growth Faltering in Infants in Bangladesh. EBioMedicine. 2015 Sep 25;2(11):1759-66. doi: 10.1016/j.ebiom.2015.09.036. eCollection 2015 Nov.

Mychaleckyj JC, Haque R, Carmolli M, Zhang D, Colgate ER, Nayak U, Taniuchi M, Dickson D, Weldon WC, Oberste MS, Zaman K, Houpt ER, Alam M, Kirkpatrick BD, Petri WA Jr. Effect of substituting IPV for tOPV on immunity to poliovirus in Bangladeshi infants: An open-label randomized controlled trial. Vaccine. 2016 Jan 12;34(3):358-66. doi: 10.1016/j.vaccine.2015.11.046. Epub 2015 Nov 28.

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Responsible Party:	Beth Kirkpatrick, M.D., University of Vermont
ClinicalTrials.gov Identifier:	NCT01375647
Other Study ID Numbers:	PROVIDE
First Posted:	June 17, 2011 Key Record Dates
Last Update Posted:	April 14, 2015
Last Verified:	April 2015

Keywords provided by Beth Kirkpatrick, University of Vermont:


Oral Vaccines Vaccine Responsiveness Tropical Enteropathy

Additional relevant MeSH terms:

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Intestinal Diseases Sprue, Tropical Diarrhea Signs and Symptoms, Digestive	Gastrointestinal Diseases Digestive System Diseases Malabsorption Syndromes Metabolic Diseases

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