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Immunogenicity of Intramuscular and Intradermal IPV (IM and ID IPV)

Primary Purpose

Poliomyelitis

Status
Terminated
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
fIPV (0.1 mL) ID
fIPV (0.1mL) IM
fIPV (0.2mL) IM
IPV
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 inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, intradermal, intramuscular

Eligibility Criteria

42 Days - 48 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants 6 weeks of age
  • 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 IPV or collection of blood by venipuncture.
  • Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
  • Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
  • Receipt of any polio vaccine (OPV or IPV) 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. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
  • 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 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

IPV at 14 weeks + 9 months

IPV at 6 weeks + 9 months

fIPV ID at 6 weeks + 14 weeks + 9 months

fIPV ID at 14 weeks + 9 months

fIPV IM at 6 weeks + 14 weeks + 9 months

fIPV 0.1mL IM at 14 weeks + 9 months

fIPV 0.2mL IM at 14 weeks + 9 months

Arm Description

Participants in this arm will receive full doses (0.5 mL) of IPV at 14 weeks and 9 months of age.

Participants in this arm will receive full doses (0.5 mL) of IPV at 6 weeks and 9 months of age.

Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.

Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.

Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.

Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.

Participants in this arm will receive intramuscular fractional doses (0.2 mL) of IPV at 14 weeks and 9 months of age.

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2019
Last Updated
May 11, 2022
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
NCT04063150
Brief Title
Immunogenicity of Intramuscular and Intradermal IPV
Acronym
IM and ID IPV
Official Title
Immunogenicity of Intramuscular and Intradermal Inactivated Poliovirus Vaccine in Routine Immunization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic
Study Start Date
October 6, 2019 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (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 compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliovirus vaccine (IPV), delivered either intramuscularly or intradermally. Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.
Detailed Description
Oral poliovirus vaccine (OPV) cessation is essential to achieve eradication of polio as OPV contains live poliovirus, which can mutate and become neurovirulent. After OPV cessation, inactivated poliovirus vaccine (IPV) will be the only polio vaccine used for routine immunization. This clinical trial will provide poliovirus type-specific immunogenicity data on an IPV or fractional-dose IPV (fIPV)-only schedule for routine immunization, which will be important for post OPV cessation era. For fIPV, it will provide immunogenicity data on fIPV administered either intradermally (ID) or intramuscularly (IM) and allow a direct comparison of the two methods. Healthy infants 6 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of seven study arms. Infants will be followed-up until 10 months of age through clinic visits. Blood specimens will be collected to test for immunological response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, intradermal, intramuscular

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
IPV at 14 weeks + 9 months
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive full doses (0.5 mL) of IPV at 14 weeks and 9 months of age.
Arm Title
IPV at 6 weeks + 9 months
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive full doses (0.5 mL) of IPV at 6 weeks and 9 months of age.
Arm Title
fIPV ID at 6 weeks + 14 weeks + 9 months
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.
Arm Title
fIPV ID at 14 weeks + 9 months
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.
Arm Title
fIPV IM at 6 weeks + 14 weeks + 9 months
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.
Arm Title
fIPV 0.1mL IM at 14 weeks + 9 months
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.
Arm Title
fIPV 0.2mL IM at 14 weeks + 9 months
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive intramuscular fractional doses (0.2 mL) of IPV at 14 weeks and 9 months of age.
Intervention Type
Biological
Intervention Name(s)
fIPV (0.1 mL) ID
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 (ID) injection in lieu of the full 0.5 mL dose.
Intervention Type
Biological
Intervention Name(s)
fIPV (0.1mL) IM
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 intramuscular (IM) injection in lieu of the full 0.5 mL dose.
Intervention Type
Biological
Intervention Name(s)
fIPV (0.2mL) IM
Intervention Description
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.2 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
Intervention Type
Biological
Intervention Name(s)
IPV
Intervention Description
Full dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection.
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).
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
48 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants 6 weeks of age 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 IPV or collection of blood by venipuncture. Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital. Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age). Evidence of a chronic medical condition identified by a study medical officer during physical exam. Receipt of any polio vaccine (OPV or IPV) 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. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants. 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

Learn more about this trial

Immunogenicity of Intramuscular and Intradermal IPV

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