Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study (mOPV1)

February 18, 2021 updated by: Centers for Disease Control and Prevention

Intestinal and Humoral Immunity of Monovalent Oral Poliovirus Vaccine Type 1 When Administered With and Without Fractional Inactivated Poliovirus Vaccine

This is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The risk for circulating vaccine-derived poliovirus (cVDPV) will increase in the years immediately after the cessation of oral poliovirus vaccine (OPV) use in routine immunization programs. Judicious use of type-specific monovalent OPV (mOPV) will be necessary for outbreak response to prevent further paralytic infections and transmission; however, data on the intestinal and humoral immunity induced by mOPV1 are very limited. Furthermore, the additional benefit of fractional dose inactivated poliovirus vaccine (fIPV) on type 1 immunity when given with mOPV1 is unclear. Data on intestinal and humoral immunity of mOPV type 1 (mOPV1) and combination use of mOPV1 and fractional dose of IPV (fIPV) are urgently needed and would be used to inform guidelines for type 1 outbreak response in a post-OPV world. In the immediate future, a strategy of shifting from bivalent OPV (bOPV) to mOPV1 as part of supplemental immunization activities in endemic countries is under consideration but data on intestinal and humoral immunity to support this change does not exist. This trial is designed to address both areas in which data are lacking.

Healthy infants 5 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of four study arms: mOPV1 + fIPV at 6 weeks, mOPV1 + fIPV at 14 weeks, mOPV1 only, and bOPV only. Infants will be followed-up until 18 weeks of age by clinic and household visits. Blood and stool specimens will be collected to test for vaccine response (humoral immunity) and vaccine virus shedding (intestinal immunity).

Study Type

Interventional

Enrollment (Actual)

1256

Phase

  • Phase 4

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

  • Bangladesh
      • Dhaka, Bangladesh
        • icddr,b study clinics (Mirpur and CTU Dhaka)

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 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy infants 5 weeks of age (range: 35-41 days).
  • Parents that consent for participation in the full length of the study.
  • Parents that are able to understand and comply with planned study procedures.

Exclusion Criteria:

  • Parents and infants who are unable to participate in the full length of the study.
  • A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
  • A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of fIPV or collection of blood by venipuncture.
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
  • Infection or illness at the enrolment visit (i.e., 5 weeks of age) that a study medical officer judges would prevent the start of study activities at 6 weeks of age (i.e., blood collection and vaccination).
  • Receipt of any polio vaccine (OPV or IPV/fIPV) before enrolment based upon documentation or parental recall.
  • Known allergy/sensitivity or reaction to polio vaccine, or its contents.
  • Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
  • Infants from premature births (<37 weeks of gestation).

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mOPV1 + fIPV 6 weeks
mOPV1 administered at 6, 10, and 14 weeks and fIPV at 6 weeks.
Biological: mOPV1
Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.
Biological: fIPV
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.
Active Comparator: mOPV1 + fIPV 10 weeks
mOPV1 administered at 6, 10, and 14 weeks and fIPV at10 weeks.
Biological: mOPV1
Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.
Biological: fIPV
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.
Active Comparator: mOPV1 only
mOPV1 administered at 6, 10, and 14 weeks.
Biological: mOPV1
Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.
Active Comparator: bOPV only
bOPV administered at 6, 10, and 14 weeks.
Biological: bOPV
Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine response
Time Frame: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.
Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.
Vaccine virus particles
Time Frame: Measured 7 and 14 days after administration of the study vaccine. For Arms B, C, and D, this will be after administration of the first mOPV1 or bOPV dose. For Arms A, B, and C, this will be after the mOPV1 challenge dose at 14 weeks of age.
Presence or absence of vaccine virus particles in stool specimens.
Measured 7 and 14 days after administration of the study vaccine. For Arms B, C, and D, this will be after administration of the first mOPV1 or bOPV dose. For Arms A, B, and C, this will be after the mOPV1 challenge dose at 14 weeks of age.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reciprocal antibody titers
Time Frame: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.
Variable of the observed reciprocal antibody titer results.
Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.

Collaborators and Investigators

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

Sponsor

Centers for Disease Control and Prevention

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

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 (Actual)

December 18, 2018

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

October 25, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-18045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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