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OpenTrials
Completed

NCT Number: NCT01375647

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

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 IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix 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.

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Key information

Conditions

Rotavirus Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Sprue, Tropical Tropical Enteropathy Vaccine Virus Shedding

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPV (inactivated polio vaccine)

Biological

Administered per protocol

Rotarix

Biological

Administered per protocol

Primary outcomes

  1. Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial)

    Time frame: 25 days following week 52 visit

    Any Sabin type poliovirus in any fecal samples at days 0, 4, 11, 18 or 25 following week 52 dose

  2. Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial)

    Time frame: Birth to one year

    Diarrheal episode defined as presence of 3 or more abnormally loose stools in 24h period with >=72 hours separating episodes. Rotavirus antigen detected by ELISA in diarrheal stool.

Secondary outcomes

  1. Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial)

    Time frame: from day 4 to day 25 following the week 52 visit

    Shedding index, calculated as duration days multiplied by mean log (shedding amount) for Sabin types 1, 2, and 3.

    Outcome is conditioned on infants with at least one detection by quantitative PCR (qPCR) at day 4,11,18, or 25. If shedding data point was missing it was assumed that the infant was not shedding at that time.

    Lower shedding index is better outcome

  2. Community Fecal Shedding of Polio Vaccine Virus Just Prior to Oral Polio Vaccine Dose at 52 Weeks (Polio Trial)

    Time frame: post 52 weeks

    Only 8 infants were shedding at baseline so results are not presented for this outcome due to insufficient data

  3. Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial)

    Time frame: 25 days following week 52 visit

    Frequency (%) of infants excreting poliovirus at any of the 5 time points (day 0, 4,11,18, 25) post week 52 oral polio vaccine dose.

    Presence of poliovirus is determined by polymerase chain reaction (PCR)

  4. Serum Neutralizing Antibody Response (Polio Trial)

    Time frame: 18-40 weeks

    Seropositive defined as antibodies present at ≥1:8 dilution, antibody titers <1:8 were seronegative.

    Non-seroconversions are those who did not seroconvert between week 18 (post oral polio vaccine dose 2) and week 40, adjusted for residual maternal antibody

  5. Total Number of Diarrheal Episodes (Rotavirus Trial)

    Time frame: Birth to one year

    A diarrheal episode is defined as the presence of 3 or more abnormally loose stools in a 24 hour period with at least 72 diarrhea-free hours separating distinct episodes

  6. Total Duration of Rotavirus-associated Diarrheal Episodes (Rotavirus Trial)

    Time frame: Birth to one year

    A diarrheal episode is defined as the presence of 3 or more abnormally loose stools in a 24 hour period with at least 72 diarrhea-free hours separating distinct episodes.

    Rotavirus positive specimens were determined by ELISA Those with no rotavirus diarrheal episodes are counted as duration 0

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • 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

Registry information

Acronym: PROVIDE

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2011
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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