Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-4
SponsorPATH
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination-temporary exclusion (see Appendix II: Severity Grading Tables). Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator.
Trial design
Design model
Sequential
Treatments tested in this trial
Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)
Biological/VaccineThe nOPV3 vaccine containing approximately 10\^5.5, 10\^6.0, or 10\^6.5 CCID50 per dose.
Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)
Biological/VaccineThe Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 control and challenge vaccine (mOPV3) containing ≥ 10\^5.8 CCID50 per dose.
Treatment groups
1,532 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: Group 1: Young Children, nOPV3 10^5.5 CCID50Experimental treatment 1 intervention
Group B: Group 3: Young Children, nOPV3 10^6.0 CCID50Experimental treatment 1 intervention
Group C: Group 5: Young Children, nOPV3 10^6.5 CCID50Experimental treatment 1 intervention
Group D: Groups 2, 4 and 6: Young Children, mOPV3Active comparator 1 intervention
Group E: Group 7: Infants, nOPV3 10^5.5 CCID50Experimental treatment 2 interventions
Group F: Group 9: Infants, nOPV3 10^5.5 CCID50Experimental treatment 2 interventions
Group G: Group 11: Infants, nOPV3 10^6.5 CCID50Experimental treatment 2 interventions
Group H: Groups 8, 10 and 12: Infants, mOPV3Active comparator 1 intervention
Group I: Group 13: Neonates, nOPV3 10^5.5 CCID50Experimental treatment 1 intervention
Group J: Group 15: Neonates, nOPV3 10^6.0 CCID50Experimental treatment 1 intervention
Group K: Group 17: Neonates, nOPV3 10^6.5 CCID50Experimental treatment 1 intervention
Group L: Groups 14, 16 and 18: Neonates, mOPVActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to last visit for last subject, around 18 months2
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
Time frame
Vaccination to 7 days post vaccination3
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.
Time frame
From vaccination to 28 days post vaccination4
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.
Time frame
28 days post second vaccinationSecondary outcomes
1
Post-vaccination frequency of seroconversion of type 3 anti-polio serum NAb
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 and for unvaccinated neonates, seroconversion will be defined as a minimum 4-fold higher antibody titer relative to the expected level of maternal antibody.
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)2
Median type 3 anti-polio serum NAb titers
Elicited by nOPV3, compared to that of mOPV3, 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)3
Type 3 anti-polio serum NAb Geometric Mean Titer (GMT)
Elicited by nOPV3, compared to that of mOPV3, 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)4
Post-vaccination GMT ratios of type 3 anti-polio serum NAb, adjusted for baseline immunity
Elicited by nOPV3, compared to that of mOPV3, 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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
PATH
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
PT Bio Farma
Collaborator
Centers for Disease Control and Prevention
Collaborator
Technical Resources International, Inc.
Collaborator
Source ClinicalTrials.gov