Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Age De-escalation, Dose Combination Ranging Study to Assess the Safety and Immunogenicity of Co-administered Novel Live Attenuated Trivalent Oral Poliomyelitis Vaccine in Healthy Adults, Young Children, and Neonates and Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines 1 and 2 in Neonates in Bangladesh
1 other identifier
interventional
2,400
1 country
2
Brief Summary
The main objectives of this study are to :
- evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines;
- evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control.
- compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;
- evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2024
Typical duration for phase_1
2 active sites
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 14, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
November 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2027
June 3, 2025
May 1, 2025
3.1 years
November 14, 2023
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants with Serious Adverse Events (SAEs)
A serious adverse event is any adverse event that results in any of the following outcomes: 1. Death. 2. Is life-threatening. 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. Congenital abnormality or birth defect. 6. 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 the time of first study vaccination through the end of the study (197 days)
Number of Participants with Solicited Adverse Events (AEs) for 7 Days After Each Vaccination
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity.
7 days (day of vaccination and 6 following days) after each vaccination
Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination.
Unsolicited AEs are any AEs reported spontaneously by the participant or parent, observed by the study personnel during study visits or identified during review of medical records or source documents.
28 days (day of vaccination and 27 following days) after each vaccination
Neonates: Seroconversion Rate of Types 1, 2, and 3 Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1, 2, and 3.
Baseline and 28 days following the last vaccination (week 18)
Neonates: Seroconversion Rate of Types 1, 2, and 1 & 2 Combined Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1 and 2 only.
Baseline and 28 days following the last vaccination (week 18)
Secondary Outcomes (11)
Neonates: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies
Baseline and weeks 6, 10, 14, and 18
Adults and Young Children: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies 4 Weeks After Each Vaccination
Baseline and Weeks 4 and 8
All Cohorts: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following Last Dose
Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following First Dose
Baseline and week 4
All Cohorts: Geometric Mean Titer (GMT) of Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibodies Following Last Dose
Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
- +6 more secondary outcomes
Study Arms (14)
Adults: High-dose (HD) nOPV1 + HD nOPV2 + HD nOPV3
EXPERIMENTALAdults will receive nOPV1 (10\^6.5 Cell Culture Infectious Dose 50% \[CCID₅₀\]) plus nOPV2 (10\^5.6 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) on Day 1 and Day 29.
Adults:bOPV
ACTIVE COMPARATORAdults will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains \>10\^6.0 infective units of type 1 and \>10\^5.8 of type 3.
Young Children: Middle-dose (MD) nOPV1 + Low-dose (LD) nOPV2 + MD nOPV3
EXPERIMENTALChildren aged ≥ 1 to \< 5 years old will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.0 CCID₅₀) on Day 1 and Day 29.
Young Children: HD nOPV1 + HD nOPV2 + HD nOPV3
EXPERIMENTALChildren aged ≥ 1 to \< 5 years old will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.6 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) on Day 1 and Day 29.
Young Children: Low-dose (LD) nOPV2
ACTIVE COMPARATORChildren aged ≥ 1 to \< 5 years old will receive nOPV2 (10\^5.3 CCID₅₀) on Day 1 and Day 29.
Young Children: bOPV
ACTIVE COMPARATORChildren aged ≥ 1 to \< 5 years old will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains \> 10\^6.0 infective units of type 1 and \> 10\^5.8 of type 3.
Neonates: MD nOPV1 + LD nOPV2 + MD nOPV3
EXPERIMENTALNewborns will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Neonates: HD nOPV1 + LD nOPV2 + HD nOPV3
EXPERIMENTALNewborns will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Neonates: MD nOPV1 + LD nOPV2 + HD nOPV3
EXPERIMENTALNewborns will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Neonates: HD nOPV1+ LD nOPV2+ MD nOPV3
EXPERIMENTALNewborns will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Neonates: HD nOPV1 + HD nOPV2 + HD nOPV3
EXPERIMENTALNewborns will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.6 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Neonates: bOPV
ACTIVE COMPARATORNewborns will receive bivalent OPV (types 1 and 3) at birth, week 6, week 10 and week 14 of life. Each dose (2 drops = 0.1 mL) contains \>10\^6.0 infective units of type 1 and \>10\^5.8 of type 3.
Neonates: MD nOPV1 + LD nOPV2
EXPERIMENTALNewborns will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Neonates: LD nOPV2
ACTIVE COMPARATORNewborns will receive nOPV2 (10\^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Interventions
Live attenuated novel poliomyelitis virus type 1 at two different dosages, containing middle-dose (MD) 10\^6.0, or high-dose (HD) 10\^6.5 CCID₅₀/dose
Live attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10\^5.3 and HD 10\^5.6 CCID₅₀/dose.
Live attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10\^6.0, or HD 10\^6.5 CCID₅₀/dose.
Live attenuated poliomyelitis viruses types 1 and 3 (Sabin strains). Each dose (2 drops = 0.1 mL) contains not less than 10\^6.0 infective units of type 1 and 10\^5.8 of type 3.
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.
- Participant or parent of the participant is willing and able to provide written informed consent prior to performance of any study-specific procedure.
- Resides and plans to remain in study area and participants and parent, when applicable, 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).
- Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment.
- If female and of childbearing potential\*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination \[if screening occurs within 24 hours prior to vaccination, a single negative pregnancy test is acceptable\]), agreeing to not become pregnant through other means (e.g., artificial insemination and IVF) and have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception\*\* for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination.
- Born and raised in Bangladesh in 1990 or later; if born before 1990 or not born and raised in Bangladesh, has documentation of a complete poliomyelitis immunization series containing OPV or IPV.
- Male or female child from 1 to less than 5 years of age at the time of enrollment (from the first birthday up to the day prior to the fifth birthday).
- Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing bOPV ± IPV, with last dose received more than 3 months prior to initial study vaccination.
- Male or female newborn neonate (day of birth+ 3-day window), at the time of initial study vaccination.
- Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based upon documentation or parental history.
- Agreement to receive polio EPI vaccines under a modified schedule.
You may not qualify if:
- 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 based on the vaccination records at the time of study vaccine administration. For household members younger than 10 years of age-appropriate vaccination is a complete series of at least three doses of OPV.
- A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
- 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.
- Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
- Evidence of a clinically significant major 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 or 20 mg/day of prednisolone (or equivalent) within 6 months prior to first study vaccine dose. Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the young child).
- Participation in another investigational product (drug or vaccine, including prior polio vaccine trials) 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 to the first administration of study vaccine, or planned participation in another investigational product clinical trial 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 during the study period.
- Participant or parent, when applicable, has any condition that in the opinion of the investigator would increase the participant's health risks in 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).
- Receipt of polio vaccine within 12 months before the start of the study.
- Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel.
- Will have household direct or close professional contact during the study with pregnant women.
- Will have household direct or close professional (e.g., neonatal nurses) contact during the study with children less than 2 years of age or with individuals who are encopretic (i.e., soiling of underwear with stool by children who are past the age of toilet training or other individuals, including adults, with fecal incontinence).
- Will have professional handling of food, catering, or food production activities during the study.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PATHlead
- Bio Farma, Indonesiacollaborator
Study Sites (2)
International Centre for Diarrhoeal Disease Research
Dhaka, 1212, Bangladesh
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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 14, 2023
First Posted
November 18, 2023
Study Start
November 20, 2024
Primary Completion (Estimated)
December 15, 2027
Study Completion (Estimated)
December 15, 2027
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share