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

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
mOPV1
bOPV
fIPV
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Poliomyelitis focused on measuring monovalent oral poliovirus vaccine type 1, bivalent oral poliovirus vaccine, inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, humoral immunity, intestinal immunity, Bangladesh

Eligibility Criteria

35 Days - 41 Days (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

mOPV1 + fIPV 6 weeks

mOPV1 + fIPV 10 weeks

mOPV1 only

bOPV only

Arm Description

mOPV1 administered at 6, 10, and 14 weeks and fIPV at 6 weeks.

mOPV1 administered at 6, 10, and 14 weeks and fIPV at10 weeks.

mOPV1 administered at 6, 10, and 14 weeks.

bOPV administered at 6, 10, and 14 weeks.

Outcomes

Primary Outcome Measures

Vaccine response
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.
Vaccine virus particles
Presence or absence of vaccine virus particles in stool specimens.

Secondary Outcome Measures

Reciprocal antibody titers
Variable of the observed reciprocal antibody titer results.

Full Information

First Posted
October 25, 2018
Last Updated
February 18, 2021
Sponsor
Centers for Disease Control and Prevention
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT03722004
Brief Title
Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study
Acronym
mOPV1
Official Title
Intestinal and Humoral Immunity of Monovalent Oral Poliovirus Vaccine Type 1 When Administered With and Without Fractional Inactivated Poliovirus Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
monovalent oral poliovirus vaccine type 1, bivalent oral poliovirus vaccine, inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, humoral immunity, intestinal immunity, Bangladesh

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mOPV1 + fIPV 6 weeks
Arm Type
Active Comparator
Arm Description
mOPV1 administered at 6, 10, and 14 weeks and fIPV at 6 weeks.
Arm Title
mOPV1 + fIPV 10 weeks
Arm Type
Active Comparator
Arm Description
mOPV1 administered at 6, 10, and 14 weeks and fIPV at10 weeks.
Arm Title
mOPV1 only
Arm Type
Active Comparator
Arm Description
mOPV1 administered at 6, 10, and 14 weeks.
Arm Title
bOPV only
Arm Type
Active Comparator
Arm Description
bOPV administered at 6, 10, and 14 weeks.
Intervention Type
Biological
Intervention Name(s)
mOPV1
Intervention Description
Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.
Intervention Type
Biological
Intervention Name(s)
bOPV
Intervention Description
Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.
Intervention Type
Biological
Intervention Name(s)
fIPV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vaccine response
Description
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.
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.
Title
Vaccine virus particles
Description
Presence or absence of vaccine virus particles in stool specimens.
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.
Secondary Outcome Measure Information:
Title
Reciprocal antibody titers
Description
Variable of the observed reciprocal antibody titer results.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Days
Maximum Age & Unit of Time
41 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
icddr,b study clinics (Mirpur and CTU Dhaka)
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

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Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study

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