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A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2

Primary Purpose

Poliomyelitis

Status
Not yet recruiting
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
nOPV2
Sponsored by
Fidec Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

5 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Infants aged 6 to 8 weeks with birth weight >2,500 g. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination. Written informed consent obtained from both parents or legal guardian(s) as per country regulations. Exclusion Criteria: Infants who have received previous vaccination against poliomyelitis. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household. Family history of congenital or hereditary immunodeficiency. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV) Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.). Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject. Infants from multiple births or born prematurely (< 37 weeks of gestation).

Sites / Locations

  • International Centre for Diarrhoeal Diseases Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPV-primed Group

bOPV-primed Group

Arm Description

Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.

Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.

Outcomes

Primary Outcome Measures

Poliovirus type-2 viral shedding
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.

Secondary Outcome Measures

Pharyngeal neutralizing antibodies (NAbs) and IgA response to poliovirus type-2.
To assess and compare the pharyngeal NAbs activity, and poliovirus type-2-specific concentrations of pharyngeal mucosal immunoglobulin A (IgA) on D0, D14 and D28 in both groups.
Seroconversion rate of poliovirus type-2 neutralizing antibodies (NAbs)
To assess the cummulative seroconversion (SC) rate of poliovirus type-2 NAbs on D28 and D56 following administration of a challenge dose of nOPV2 in both groups.Seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher titer (and seropositivity) than that which is expected due to maternal antibodies.
Incidence of Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
To assess the number of subjects experiencing SAEs and IMEs following administration of IPV, bOPV and nOPV2 throughout the whole study period.

Full Information

First Posted
December 9, 2022
Last Updated
June 14, 2023
Sponsor
Fidec Corporation
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05677256
Brief Title
A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2
Official Title
A Phase IV Open-label, Randomized, Parallel-group Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2 in Healthy bOPV- Versus IPV-vaccinated Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 12, 2023 (Anticipated)
Primary Completion Date
January 4, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidec Corporation
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

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

5. Study Description

Brief Summary
The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants
Detailed Description
In the light of the switch from OPV to IPV and the continued presence of cVDPV2 in many countries, it is important to understand and quantify the impact of IPV on pharyngeal mucosal immunity, to inform whether and to what extent the mucosal and humoral immune response following IPV could reduce transmission and spread. This study will assess the effect of vaccination with IPV in parallel with poliovirus type-2 naïve infants (infants having received bOPV) on the pharyngeal and fecal shedding and the induction of immunity following type-2 poliovirus challenge. This understanding would provide critical information on the potential use of IPV in specific settings to interrupt transmission / reduce spread. The results from this study may potentially have important consequences on public health policy in countries which use IPV for infant priming, as they will help to show the extent to which a type-2 mucosal immunity gap remains following a primary series of IPV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPV-primed Group
Arm Type
Experimental
Arm Description
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
Arm Title
bOPV-primed Group
Arm Type
Active Comparator
Arm Description
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
Intervention Type
Biological
Intervention Name(s)
nOPV2
Intervention Description
Vaccination
Primary Outcome Measure Information:
Title
Poliovirus type-2 viral shedding
Description
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pharyngeal neutralizing antibodies (NAbs) and IgA response to poliovirus type-2.
Description
To assess and compare the pharyngeal NAbs activity, and poliovirus type-2-specific concentrations of pharyngeal mucosal immunoglobulin A (IgA) on D0, D14 and D28 in both groups.
Time Frame
1 month
Title
Seroconversion rate of poliovirus type-2 neutralizing antibodies (NAbs)
Description
To assess the cummulative seroconversion (SC) rate of poliovirus type-2 NAbs on D28 and D56 following administration of a challenge dose of nOPV2 in both groups.Seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher titer (and seropositivity) than that which is expected due to maternal antibodies.
Time Frame
2 months
Title
Incidence of Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
Description
To assess the number of subjects experiencing SAEs and IMEs following administration of IPV, bOPV and nOPV2 throughout the whole study period.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants aged 6 to 8 weeks with birth weight >2,500 g. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination. Written informed consent obtained from both parents or legal guardian(s) as per country regulations. Exclusion Criteria: Infants who have received previous vaccination against poliomyelitis. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household. Family history of congenital or hereditary immunodeficiency. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV) Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.). Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject. Infants from multiple births or born prematurely (< 37 weeks of gestation).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo Rüttimann, MD
Phone
+5491161188536
Email
rruttimann@fidec-online.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Aguirre
Phone
+5491159647383
Email
gaguirre@fidec-online.org
Facility Information:
Facility Name
International Centre for Diarrhoeal Diseases Research
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Zaman, Dr.
Phone
88 02 9827001-10
Ext
3806
Email
kzaman@icddrb.org

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2

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