Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
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
1 other identifier
interventional
2,232
1 country
1
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 (720 subjects), and neonates (1320 subjects).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedStudy Start
First participant enrolled
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2026
January 9, 2026
January 1, 2026
3.1 years
November 10, 2022
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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: 1. Death 2. 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). 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. 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
From Day 1 to end of study, up to Day 197 (young children and neonates) or Day 225 (infants)
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
From vaccination to 7 days post vaccination
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.
From vaccination to 28 days post vaccination
Post-vaccination frequency of seroconversion of type 1 anti-polio serum neutralizing antibody (NAb).
Following two doses of nOPV1, at dose levels of 10\^6.5 and 10\^7.0 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.
28 days post second vaccination
Secondary Outcomes (9)
Post-vaccination frequency of seroconversion of type 1 anti-polio serum NAb.
Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Median type 1 anti-polio serum NAb titers.
Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Type 1 anti-polio serum NAb Geometric Mean Titer (GMT).
Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Post-vaccination GMT ratios of type 1 anti-polio serum NAb, adjusted for baseline immunity.
Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Seroprotection rate, defined as type 1 anti-polio serum NAb reciprocal titer ≥ 8.
Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
- +4 more secondary outcomes
Study Arms (15)
Group 1: Young Children, nOPV1 10^5.5 CCID50
EXPERIMENTAL48 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
Group 3: Young Children, nOPV1 10^6.0 CCID50
EXPERIMENTAL48 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
Group 5: Young Children, nOPV1 10^6.5 CCID50
EXPERIMENTAL48 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
Groups 2, 4 and 6: Young Children, mOPV1
ACTIVE COMPARATOR48 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
Group 7: Infants, nOPV1 10^5.5 CCID50
EXPERIMENTAL96 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.
Group 9: Infants, nOPV1 10^6.0 CCID50
EXPERIMENTAL96 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.
Group 11: Infants, nOPV1 10^6.5 CCID50
EXPERIMENTAL48 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\^6.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Group 11b: Infants, nOPV1 10^6.5 CCID50
EXPERIMENTAL96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Group 13: Infants, nOPV1 10^7.0 CCID50
EXPERIMENTAL96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^7.0 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Group 15: Infants, nOPV1 10^7.5 CCID50
EXPERIMENTAL96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^7.5 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Groups 8, 10, 12, 12b, 14, 16: Infants mOPV1
ACTIVE COMPARATOR192 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1 then 2 to 3 doses of mOPV1 at a dose level of ≥10\^6.0 CCID50 on Day 29, Day 57, Day 85 (groups 12b, 14 \& 16 only) and a challenge dose of mOPV on Day 113 (groups 8, 10 \& 12) on Day 141 (groups 12b, 14 \& 16)
Group 17: Neonates, nOPV1 10^6.5 CCID50
EXPERIMENTAL330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 1, Day 29 \& Day 57
Group 19: Neonates, nOPV1 10^7.0 CCID50
EXPERIMENTAL330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^7.0 CCID50 on Day 1, Day 29 \& Day 57
Group 21: Neonates, nOPV1 10^7.5 CCID50
EXPERIMENTAL330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^7.5 CCID50 on Day 1, Day 29 \& Day 57
Groups 18, 20 & 22: Neonates, mOPV1
ACTIVE COMPARATOR330 neonates (day of birth +3 days) will receive 3 doses of mOPV1 at a dose level of ≥ 10\^6.0 CCID50 on Day 1, Day 29 \& Day 57
Interventions
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.
Drop counts of nOPV vaccine will be varied to achieve approximately 10\^5.5, 10\^6.0, 10\^6.5 CCID50 or 10\^7.0, 10\^7.5 dose levels.
Eligibility Criteria
You may qualify if:
- 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
- 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
- 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.
- 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.
You may not qualify if:
- 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). Note: A vaccination series of tOPV or at least three doses of bOPV with our without a booster fractional dose of IPV will be considered sufficient.
- 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.
- 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 within 6 months 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
- Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior tot he first administration of study vaccine, or planned use during the study period.
- Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned use during the study period.
- Parent or participant has any condition that in the opinion of the investigator would increase the participant's health risks in the study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments.)
- Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500g (up to and including 2499b) at the time of birth or by the time of enrolment.
- Premature birth (less than 37 weeks gestation)
- From multiple birth (due to increased risk of OPV transmission between siblings)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmacollaborator
- Centers for Disease Control and Preventioncollaborator
- DiagnoSearch Life Sciences Pvt. Ltd.collaborator
- PATHlead
- Bill and Melinda Gates Foundationcollaborator
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, 1212, Bangladesh
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
K. Zaman, MBBS, MPH, PhD, FRCP
International Centre for Diarrhoeal Disease Research, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
December 9, 2022
Study Start
March 27, 2023
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
May 15, 2026
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share