Diarrhea and Bivalent Oral Polio Vaccine Immunity

October 13, 2015 updated by: Centers for Disease Control and Prevention

Effect of Diarrheal Disease on Bivalent Oral Polio Vaccine (bOPV) Immune Response in Infants in Nepal

Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate eradication. One concern in this effort is that some populations have decreased immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV) was recommended for use in immunization campaigns, and will likely replace tOPV in routine immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been studied.

This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who reside in Nepal. The investigators conducted a prospective, interventional study that assessed immune response to bOPV among infants with and without diarrhea. Immune responses were compared among infants with and without diarrhea.

This study will result in a better understanding of the factors that decrease the ability of some children to seroconvert to OPV and be protected from poliomyelitis infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

699

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Institute of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 11 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The investigators will be including Nepali infants aged at least 6 weeks and no more than 12 months, who have received <3 doses of OPV (cumulative from routine and SIA) and present to outpatient clinics in participating study sites. Whenever possible, the child's immunization status based on the caretaker's report will be cross-checked with available immunization cards.
  • Infants with diarrhea must also have:
  • Current diarrhea, defined as three loose stools per day in the past 24 hours. This may include children with acute or chronic diarrhea, low grade fever, and those with intermittent vomiting who are able to tolerate oral fluids and do not present with severe dehydration on the initial visit.
  • Non-diarrhea children also must:
  • Present with other, non-diarrheal minor acute complaints. This can include but is not limited to children presenting for non-severe illnesses such as skin problems (e.g., rash), conjunctivitis, and mild cough, congestion, or cold. These children should be diarrhea-free for at least two weeks prior to enrolment.

Exclusion Criteria:

  • Infants younger than 6 weeks or older than 12 months of age
  • Infants who have received 3 or more cumulative doses of OPV (including both routine and SIAs)
  • Infants who require hospitalization or are deemed too ill to participate by the study site clinician
  • Infants with blood in the stool (as this may represent more severe cases including dysentery, or non-infectious severe illnesses such as intussusception)
  • Infants who require IV medications for a severe illness (e.g., pneumonia); however, this does not include medications for mild or moderate illnesses, such as paracetamol, ORS, eye ointment, etc.
  • Infants who have a chronic underlying illness requiring long term medications
  • Infants who are unable to take any oral fluids by mouth, require IV hydration and therefore would be unable to tolerate oral medications in the study
  • Infants whose caregivers do not consent, or are not present to give consent, to the study
  • Infants who will not be able to return to the clinic to participate the full length of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Diarrhea
Infants with diarrhea will have blood and stool sample taken and receive zinc and ORS. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion.
Biological: bivalent oral polio vaccine
vaccine given during immunization campaigns
ACTIVE_COMPARATOR: Non-diarrhea
Infants without diarrhea will have blood and stool sample taken and receive multivitamins. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion.
Biological: bivalent oral polio vaccine
vaccine given during immunization campaigns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of infants who seroconvert or boost in antibody titers in the diarrhea arm compared to the non-diarrhea arm
Time Frame: 4 weeks after date of bOPV dose

Seropositive: antibody titer of at least 1:8 for poliovirus type 1 or 3

Seronegative: antibody titer of less than 1:8 for poliovirus type 1 or 3

Seroconversion: proportion of children who change from seronegative to seropositive to types 1 or 3, four weeks after receipt of bOPV.

Boost (increase in titer): seropositives at baseline who increase at least 4-fold in antibody titer four weeks after receipt of bOPV.
4 weeks after date of bOPV dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of enteric infections isolated in stool among infants with diarrhea vs. infants without diarrhea
Time Frame: Date of enrollment
One stool sample will be collected from each infant the day of enrollment.
Date of enrollment
Proportion of infants seropositive after receipt of 3 doses of any oral polio vaccine
Time Frame: 4 weeks after date of bOPV dose
A subset of infants who received two doses of any OPV prior to study entry, and a third dose of bOPV as part of the study, will have their seroimmunity reported. This outcome is intended as a proxy measure for seroprevalence after 3 doses of OPV, which is how the vaccine is used in routine immunization.
4 weeks after date of bOPV dose
Proportion of infants with factors associated with poor bOPV seroconversion/boosting
Time Frame: 4 weeks after date of bOPV dose
Multivariable modeling will be used to assess factors associated with poor bOPV seroconversion/boosting.
4 weeks after date of bOPV dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

Tribhuvan University, Nepal

Investigators

  • Principal Investigator: Cristina V Cardemil, MD, MPH, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-458-GID-037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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