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Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

Primary Purpose

Poliomyelitis

Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Sponsored by
PATH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Vaccine tolerability, Vaccine safety, Vaccine reactogenicity, Vaccine viral shedding, Vaccine immunogenicity

Eligibility Criteria

0 Days - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria for all participants: Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator) Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule Inclusion Criteria for Cohort 1 (young children) participants only: Male or female child from 1 to less than 5 years of age at the time of initial study vaccination Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing OPV (may have also received IPV), with last dose received more than 3 months prior to initial study vaccination Inclusion Criteria for Cohort 2 (infants) participants only: Male or female infant expected to be 6 weeks of age (43rd to 49th day of life [with day of birth being the first day of life], inclusive+ 6-day window), at the time of initial study vaccination Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation. Inclusion Criteria for Cohort 3 (neonates) participants only: Male or female newborn (1st day of life+ 3-day window, inclusive), at the time of initial study vaccination Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based on no evidence of such vaccination per available documentation. Exclusion Criteria for all participants: For all participants, the presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration. For household members younger than 10 years of age, "age appropriate" vaccination is complete series of trivalent Oral Poliovirus Vaccine (tOPV) or at least three doses of bivalent (types 1 and 3) Oral Poliovirus Vaccine (bOPV) plus a booster fractional dose of IPV (fractional dose Inactivated Polio Vaccine; fIPV). For all participants, having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration. Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination - temporary exclusion. Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator. Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2) A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin) Evidence of a clinically significant congenital or genetic defect as judged by the investigator History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (> 0.5mg/kg/day of prednisolone (or equivalent)). Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the infant/young child) Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof/in the same building rather than in the same compound) Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection

Sites / Locations

  • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1: Young Children, nOPV1 10^5.5 CCID50

Group 3: Young Children, nOPV1 10^6.0 CCID50

Group 5: Young Children, nOPV1 10^6.5 CCID50

Groups 2, 4 and 6: Young Children, mOPV1

Group 7: Infants, nOPV1 10^5.5 CCID50

Group 9: Infants, nOPV1 10^6.0 CCID50

Group 11: Infants, nOPV1 10^6.5 CCID50

Groups 8, 10 and 12: Infants, mOPV1

Group 13: Neonates, nOPV1 10^5.5 CCID50

Group 15: Neonates, nOPV1 10^6.0 CCID50

Group 17: Neonates, nOPV1 10^6.5 CCID50

Groups 14, 16 and 18: Neonates, mOPV

Arm Description

48 young children aged 1 to <5 years will receive 2 doses of nOPV1 at a dose level of 10^5.5 CCID50 on Day 1 and Day 29

48 young children aged 1 to <5 years will receive 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 1 and Day 29

48 young children aged 1 to <5 years will receive 2 doses of nOPV1 at a dose level of 10^6.5 CCID50 on Day 1 and Day 29

48 young children aged 1 to <5 years will receive 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 1 and Day 29

96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10^5.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

48 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

330 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^5.5 CCID50 on Day 1 and Day 29.

330 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 1 and Day 29.

165 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^6.5 CCID50 on Day 1 and Day 29.

330 neonates (day of birth + 3 days) will receive 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 1 and Day 29

Outcomes

Primary Outcome Measures

Frequency of serious adverse events (SAEs) from the time of first study vaccination through the end of the study
Serious adverse event is any adverse event that results in any of the following outcomes: Death Is life-threatening (life-threatening means that the study participant was, in the opinion of the site PI or PATH, at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event
Frequency of solicited adverse events (AEs) for 7 days (day of vaccination and 6 following days) after each vaccination
Solicited AEs are pre-specific AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. The following specific solicited AEs will be monitored for this trial: Fever (axillary temperature ≥ 37.5°C) Vomiting Diarrhea Irritability Decreased feeding or appetite Fatigue or decreased activity
Frequency of unsolicited AEs for 28 days (day of vaccination and 27 following days) after each vaccination
Unsolicited AEs are any AEs reported spontaneously by the participant's parent, observed by the study personnel during study visits or identified during review of medical records or source documents. In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant will be reported as an AE.
Post-vaccination frequency of seroconversion of type 1 anti-polio serum neutralizing antibody (NAb).
Following two doses of nOPV1, at dose levels of 10^6.0 and 10^5.5 CCID50/dose, compared to mOPV1, in healthy neonates. For unvaccinated neonates, seroconversion will be defined as either a minimum 4-fold higher antibody titer relative to the expected level of maternal antibody and seropositivity (reciprocal titer ≥ 8) at the post-vaccination time point among those initially seropositive, or post-vaccination seropositivity among those initially seronegative.

Secondary Outcome Measures

Post-vaccination frequency of seroconversion of type 1 anti-polio serum NAb.
At dose levels of 10^6.0 and 10^5.5 CCID50/dose following one dose in healthy neonates, and following one or two doses in healthy young children and infants at all dose levels, compared to mOPV1. For unvaccinated neonates, seroconversion will be defined as either a minimum 4-fold higher antibody titer relative to the expected level of maternal antibody and seropositivity (reciprocal titer ≥ 8) at the post-vaccination time point among those initially seropositive, or post-vaccination seropositivity among those initially seronegative. For previously vaccinated cohorts, seroconversion will be defined as either a minimum 4-fold rise in titer relative to the baseline value among those initially seropositive, or post-vaccination seropositivity among those seronegative at baseline.
Median type 1 anti-polio serum NAb titers.
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Type 1 anti-polio serum NAb Geometric Mean Titer (GMT).
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Post-vaccination GMT ratios of type 1 anti-polio serum NAb, adjusted for baseline immunity.
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Seroprotection rate, defined as type 1 anti-polio serum NAb reciprocal titer ≥ 8.
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Geometric mean fold rise (GMFR) in NAb titer relative to baseline for post-dose-1 and relative to post-dose-1 for post-dose-2.
Elicited by nOPV1, compared to that of mOPV1, in healthy young children, infants, and neonates.
Proportion of participants shedding type 1 poliovirus at any and at each post-vaccination stool collection, as assessed by polymerase chain reaction (PCR) in infants and neonates.
After the initial dose of nOPV1, compared to mOPV1.
Proportion of participants shedding type 1 poliovirus at any and at each post-challenge stool collection, as assessed by PCR in infants.
In participants negative for type 1 poliovirus in their last pre-challenge stool sample.
Neurovirulence of shed study vaccine virus from select stool samples as measured by a transgenic mouse neurovirulence test in a subset of neonates.
Within 28 days of an initial nOPV dose and compared to that of mOPV1.

Full Information

First Posted
November 10, 2022
Last Updated
May 26, 2023
Sponsor
PATH
Collaborators
Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, DiagnoSearch Life Sciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05644184
Brief Title
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Official Title
A Phase 2, Randomized, Observer-blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess Safety and Immunogenicity of a Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PATH
Collaborators
Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, DiagnoSearch Life Sciences Pvt. Ltd.

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
The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (336 subjects), and neonates (1155 subjects).
Detailed Description
This single-center trial is is the first clinical assessment of nOPV1 in a pediatric population. It will be a 12-arm, randomized, observer-blind, controlled trial, with Sabin monovalent type 1 vaccine (mOPV1) serving as the control. Enrollment in this pediatric study will be staggered into three age-descending cohorts, Cohort 1 composed of 192 healthy young children 1 to less than 5 years of age who have completed their full routine polio immunization series, Cohort 2 composed of 336 healthy infants 6 weeks of age (+6 days) who will receive only one dose of inactivated poliomyelitis vaccine (IPV) on Day 1, and finally Cohort 3, composed of 1155 healthy poliomyelitis unvaccinated neonates (day of birth +3 days). Participants will receive two doses of either nOPV1 at dose levels of 10^5.5 CCID50, 10^6.0 CCID50 or 10^6.5 CCID50, or the mOPV control vaccine. The second dose of vaccine will be given 28 days following the first dose. In order to demonstrate the vaccine's ability to reduce fecal shedding following a challenge with the Sabin type 1 strain, the infant cohort will be challenged with mOPV 8 weeks after the second vaccine dose. Participants will be followed until 28 weeks (young children and neonates) or 32 weeks (infants) after their Day 1 vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Vaccine tolerability, Vaccine safety, Vaccine reactogenicity, Vaccine viral shedding, Vaccine immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
A 12-arm, randomized, observer-blind, controlled, age de-escalation, dosage escalation study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1683 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Young Children, nOPV1 10^5.5 CCID50
Arm Type
Experimental
Arm Description
48 young children aged 1 to <5 years will receive 2 doses of nOPV1 at a dose level of 10^5.5 CCID50 on Day 1 and Day 29
Arm Title
Group 3: Young Children, nOPV1 10^6.0 CCID50
Arm Type
Experimental
Arm Description
48 young children aged 1 to <5 years will receive 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 1 and Day 29
Arm Title
Group 5: Young Children, nOPV1 10^6.5 CCID50
Arm Type
Experimental
Arm Description
48 young children aged 1 to <5 years will receive 2 doses of nOPV1 at a dose level of 10^6.5 CCID50 on Day 1 and Day 29
Arm Title
Groups 2, 4 and 6: Young Children, mOPV1
Arm Type
Active Comparator
Arm Description
48 young children aged 1 to <5 years will receive 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 1 and Day 29
Arm Title
Group 7: Infants, nOPV1 10^5.5 CCID50
Arm Type
Experimental
Arm Description
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10^5.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Arm Title
Group 9: Infants, nOPV1 10^6.0 CCID50
Arm Type
Experimental
Arm Description
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Arm Title
Group 11: Infants, nOPV1 10^6.5 CCID50
Arm Type
Experimental
Arm Description
48 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Arm Title
Groups 8, 10 and 12: Infants, mOPV1
Arm Type
Active Comparator
Arm Description
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Arm Title
Group 13: Neonates, nOPV1 10^5.5 CCID50
Arm Type
Experimental
Arm Description
330 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^5.5 CCID50 on Day 1 and Day 29.
Arm Title
Group 15: Neonates, nOPV1 10^6.0 CCID50
Arm Type
Experimental
Arm Description
330 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 1 and Day 29.
Arm Title
Group 17: Neonates, nOPV1 10^6.5 CCID50
Arm Type
Experimental
Arm Description
165 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^6.5 CCID50 on Day 1 and Day 29.
Arm Title
Groups 14, 16 and 18: Neonates, mOPV
Arm Type
Active Comparator
Arm Description
330 neonates (day of birth + 3 days) will receive 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 1 and Day 29
Intervention Type
Biological
Intervention Name(s)
Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Intervention Description
Each 0.1 mL (2 drops) dose of nOPV1 vaccine contains approximately 10^5.5, 10^6.0, or 10^6.5 CCID50.
Intervention Type
Biological
Intervention Name(s)
Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Intervention Description
The Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 control and challenge vaccine (mOPV1) contains ≥ 10^6.0 CCID50 per 0.1 mL (2 drops) dose.
Primary Outcome Measure Information:
Title
Frequency of serious adverse events (SAEs) from the time of first study vaccination through the end of the study
Description
Serious adverse event is any adverse event that results in any of the following outcomes: Death Is life-threatening (life-threatening means that the study participant was, in the opinion of the site PI or PATH, at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event
Time Frame
From Day 1 to end of study, up to Day 197 (young children and neonates) or Day 225 (infants)
Title
Frequency of solicited adverse events (AEs) for 7 days (day of vaccination and 6 following days) after each vaccination
Description
Solicited AEs are pre-specific AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. The following specific solicited AEs will be monitored for this trial: Fever (axillary temperature ≥ 37.5°C) Vomiting Diarrhea Irritability Decreased feeding or appetite Fatigue or decreased activity
Time Frame
From vaccination to 7 days post vaccination
Title
Frequency of unsolicited AEs for 28 days (day of vaccination and 27 following days) after each vaccination
Description
Unsolicited AEs are any AEs reported spontaneously by the participant's parent, observed by the study personnel during study visits or identified during review of medical records or source documents. In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant will be reported as an AE.
Time Frame
From vaccination to 28 days post vaccination
Title
Post-vaccination frequency of seroconversion of type 1 anti-polio serum neutralizing antibody (NAb).
Description
Following two doses of nOPV1, at dose levels of 10^6.0 and 10^5.5 CCID50/dose, compared to mOPV1, in healthy neonates. For unvaccinated neonates, seroconversion will be defined as either a minimum 4-fold higher antibody titer relative to the expected level of maternal antibody and seropositivity (reciprocal titer ≥ 8) at the post-vaccination time point among those initially seropositive, or post-vaccination seropositivity among those initially seronegative.
Time Frame
28 days post second vaccination
Secondary Outcome Measure Information:
Title
Post-vaccination frequency of seroconversion of type 1 anti-polio serum NAb.
Description
At dose levels of 10^6.0 and 10^5.5 CCID50/dose following one dose in healthy neonates, and following one or two doses in healthy young children and infants at all dose levels, compared to mOPV1. For unvaccinated neonates, seroconversion will be defined as either a minimum 4-fold higher antibody titer relative to the expected level of maternal antibody and seropositivity (reciprocal titer ≥ 8) at the post-vaccination time point among those initially seropositive, or post-vaccination seropositivity among those initially seronegative. For previously vaccinated cohorts, seroconversion will be defined as either a minimum 4-fold rise in titer relative to the baseline value among those initially seropositive, or post-vaccination seropositivity among those seronegative at baseline.
Time Frame
Baseline and 28 days post vaccination (Day 1 and Day 29 for neonates; Day 29, Day 57 and Day 85 for infants; Day 1, Day 29 and Day 57 young children)
Title
Median type 1 anti-polio serum NAb titers.
Description
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Time Frame
Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)
Title
Type 1 anti-polio serum NAb Geometric Mean Titer (GMT).
Description
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Time Frame
Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)
Title
Post-vaccination GMT ratios of type 1 anti-polio serum NAb, adjusted for baseline immunity.
Description
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Time Frame
Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)
Title
Seroprotection rate, defined as type 1 anti-polio serum NAb reciprocal titer ≥ 8.
Description
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, infants, and neonates.
Time Frame
Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)
Title
Geometric mean fold rise (GMFR) in NAb titer relative to baseline for post-dose-1 and relative to post-dose-1 for post-dose-2.
Description
Elicited by nOPV1, compared to that of mOPV1, in healthy young children, infants, and neonates.
Time Frame
Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)
Title
Proportion of participants shedding type 1 poliovirus at any and at each post-vaccination stool collection, as assessed by polymerase chain reaction (PCR) in infants and neonates.
Description
After the initial dose of nOPV1, compared to mOPV1.
Time Frame
Baseline through to 28 days post initial vaccination (Day 29 through to Day 57 for infants; Day 1 through to Day 29 for neonates)
Title
Proportion of participants shedding type 1 poliovirus at any and at each post-challenge stool collection, as assessed by PCR in infants.
Description
In participants negative for type 1 poliovirus in their last pre-challenge stool sample.
Time Frame
Day of challenge through to 28 days post challenge (Day 113 through to Day 141, for infants)
Title
Neurovirulence of shed study vaccine virus from select stool samples as measured by a transgenic mouse neurovirulence test in a subset of neonates.
Description
Within 28 days of an initial nOPV dose and compared to that of mOPV1.
Time Frame
Baseline through to 28 days post initial vaccination (Day 1 through to Day 29 for neonates)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for all participants: Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator) Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule Inclusion Criteria for Cohort 1 (young children) participants only: Male or female child from 1 to less than 5 years of age at the time of initial study vaccination Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing OPV (may have also received IPV), with last dose received more than 3 months prior to initial study vaccination Inclusion Criteria for Cohort 2 (infants) participants only: Male or female infant expected to be 6 weeks of age (43rd to 49th day of life [with day of birth being the first day of life], inclusive+ 6-day window), at the time of initial study vaccination Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation. Inclusion Criteria for Cohort 3 (neonates) participants only: Male or female newborn (1st day of life+ 3-day window, inclusive), at the time of initial study vaccination Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based on no evidence of such vaccination per available documentation. Exclusion Criteria for all participants: For all participants, the presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration. For household members younger than 10 years of age, "age appropriate" vaccination is complete series of trivalent Oral Poliovirus Vaccine (tOPV) or at least three doses of bivalent (types 1 and 3) Oral Poliovirus Vaccine (bOPV) plus a booster fractional dose of IPV (fractional dose Inactivated Polio Vaccine; fIPV). For all participants, having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration. Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination - temporary exclusion. Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator. Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2) A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin) Evidence of a clinically significant congenital or genetic defect as judged by the investigator History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (> 0.5mg/kg/day of prednisolone (or equivalent)). Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the infant/young child) Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof/in the same building rather than in the same compound) Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tushar Tewari, MD
Phone
+91 11 4064 0005
Email
ttewari@path.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Zaman, MBBS, MPH, PhD, FRCP
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Zaman, MBBS, MPH, PhD, FRCP
Phone
+880 2 9827001 10
Ext
3806
Email
kzaman@icddrb.org
First Name & Middle Initial & Last Name & Degree
K. Zaman, MBBS, MPH, PhD, FRCP

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

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