Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
A Phase 2, Randomized, Observer-Blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess the Safety and Immunogenicity of a Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Panama
2 other identifiers
interventional
1,532
1 country
3
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 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 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 Dec 2023
3 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
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedStudy Start
First participant enrolled
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2025
CompletedFebruary 28, 2024
February 1, 2024
2 years
December 7, 2022
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Frequency of serious adverse events (SAEs)
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 PIs 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. 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.
Up to last visit for last subject, around 18 months
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
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 3 anti-polio serum neutralizing antibody (NAb) in infants.
For previously vaccinated cohorts, seroconversion will be defined as a minimum 4-fold rise in titer relative to the baseline value among those initially seropositive.
28 days post second vaccination
Secondary Outcomes (9)
Post-vaccination frequency of seroconversion of type 3 anti-polio serum NAb
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)
Median type 3 anti-polio serum NAb titers
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)
Type 3 anti-polio serum NAb Geometric Mean Titer (GMT)
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)
Post-vaccination GMT ratios of type 3 anti-polio serum NAb, adjusted for baseline immunity
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)
Seroprotection rate, defined as type 3 anti-polio serum NAb reciprocal titer ≥ 8
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)
- +4 more secondary outcomes
Study Arms (12)
Group 1: Young Children, nOPV3 10^5.5 CCID50
EXPERIMENTAL48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 1 and Day 29
Group 3: Young Children, nOPV3 10^6.0 CCID50
EXPERIMENTAL48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 1 and Day 29
Group 5: Young Children, nOPV3 10^6.5 CCID50
EXPERIMENTAL48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 1 and Day 29
Groups 2, 4 and 6: Young Children, mOPV3
ACTIVE COMPARATOR48 young children aged 1 to \<5 years will receive 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 1 and Day 29
Group 7: Infants, nOPV3 10^5.5 CCID50
EXPERIMENTAL240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 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, nOPV3 10^5.5 CCID50
EXPERIMENTAL240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 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, nOPV3 10^6.5 CCID50
EXPERIMENTAL140 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Groups 8, 10 and 12: Infants, mOPV3
ACTIVE COMPARATOR240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Group 13: Neonates, nOPV3 10^5.5 CCID50
EXPERIMENTAL120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 1 and Day 29.
Group 15: Neonates, nOPV3 10^6.0 CCID50
EXPERIMENTAL120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 1 and Day 29.
Group 17: Neonates, nOPV3 10^6.5 CCID50
EXPERIMENTAL120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 1 and Day 29.
Groups 14, 16 and 18: Neonates, mOPV
ACTIVE COMPARATOR120 neonates (day of birth + 3 days) will receive 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 1 and Day 29
Interventions
The nOPV3 vaccine containing approximately 10\^5.5, 10\^6.0, or 10\^6.5 CCID50 per dose.
The Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 control and challenge vaccine (mOPV3) containing ≥ 10\^5.8 CCID50 per dose.
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(s) or guardian(s) 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(s) or guardian(s) 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 \<5 years-of-age at the time of initial study vaccination.
- Based on available documentation or parental/guardian(s) report, previously completed the primary poliomyelitis immunization series for the jurisdiction, with last dose received more than 28 days 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 parental/guardian(s) report or documentation.
- Male or female newborn (1st day of life + 3-day window), at the time of initial study vaccination.
- Prior to study vaccination has received no doses of IPV or OPV vaccine, based on no evidence of such vaccination per available parental/guardian(s) report or 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 appropriate vaccination is complete series of the primary poliomyelitis immunization series for the jurisdiction.
- 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 three 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.
- Presence of fever on the day of enrollment/first study vaccination (axillary temperature
- 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 systemic 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.
- 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 to the 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(s) or guardian(s) or participant 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).
- Premature birth (less than 37 weeks gestation or less than 2500 grams birth weight).
- From multiple birth (due to increased risk of OPV transmissions between siblings).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PATHlead
- Bill and Melinda Gates Foundationcollaborator
- PT Bio Farmacollaborator
- Centers for Disease Control and Preventioncollaborator
- Technical Resources International, Inc. (TRI)collaborator
Study Sites (3)
Cevaxin - 24 de Diciembre
Panama City, Panama
Cevaxin - Chorrera
Panama City, Panama
Cevaxin-- Avenida Mexico
Panama City, Panama
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier Saez-Llorens, MD
Cevaxin
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
December 7, 2022
First Posted
December 16, 2022
Study Start
December 5, 2023
Primary Completion
November 20, 2025
Study Completion
November 20, 2025
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share