Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-45
SponsorPATH
About this trial
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.
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.
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Novel oral poliomyelitis vaccine type 1 (nOPV1)
Biological/VaccineLive 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
Novel oral poliomyelitis vaccine type 2 (nOPV2)
Biological/VaccineLive attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10\^5.3 and HD 10\^5.6 CCID₅₀/dose.
Novel oral poliomyelitis vaccine type 3 (nOPV3)
Biological/VaccineLive attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10\^6.0, or HD 10\^6.5 CCID₅₀/dose.
Bivalent Oral Poliomyelitis Vaccine (bOPV)
Biological/VaccineLive 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.
Treatment groups
2,400 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Group A: Adults: High-dose (HD) nOPV1 + HD nOPV2 + HD nOPV3Experimental treatment 3 interventions
Group B: Adults:bOPVActive comparator 1 intervention
Group C: Young Children: Middle-dose (MD) nOPV1 + Low-dose (LD) nOPV2 + MD nOPV3Experimental treatment 3 interventions
Group D: Young Children: HD nOPV1 + HD nOPV2 + HD nOPV3Experimental treatment 3 interventions
Group E: Young Children: Low-dose (LD) nOPV2Active comparator 1 intervention
Group F: Young Children: bOPVActive comparator 1 intervention
Group G: Neonates: MD nOPV1 + LD nOPV2 + MD nOPV3Experimental treatment 3 interventions
Group H: Neonates: HD nOPV1 + LD nOPV2 + HD nOPV3Experimental treatment 3 interventions
Group I: Neonates: MD nOPV1 + LD nOPV2 + HD nOPV3Experimental treatment 3 interventions
Group J: Neonates: HD nOPV1+ LD nOPV2+ MD nOPV3Experimental treatment 3 interventions
Group K: Neonates: HD nOPV1 + HD nOPV2 + HD nOPV3Experimental treatment 3 interventions
Group L: Neonates: bOPVActive comparator 1 intervention
Group M: Neonates: MD nOPV1 + LD nOPV2Experimental treatment 2 interventions
Group N: Neonates: LD nOPV2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the time of first study vaccination through the end of the study (197 days)2
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.
Time frame
7 days (day of vaccination and 6 following days) after each vaccination3
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.
Time frame
28 days (day of vaccination and 27 following days) after each vaccination4
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.
Time frame
Baseline and 28 days following the last vaccination (week 18)Secondary outcomes
1
Neonates: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies
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. Multitypic seroconversion refers to seroconversion to multiple types simultaneously, including types 1 \& 2, types 1 \& 3, types 2 \& 3, and types 1 \& 2 \& 3.
Time frame
Baseline and weeks 6, 10, 14, and 182
Adults and Young Children: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies 4 Weeks After Each Vaccination
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. This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame
Baseline and Weeks 4 and 83
All Cohorts: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following Last Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame
Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)4
Adults and Young Children: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following First Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame
Baseline and week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
PATH
Lead sponsor
Bio Farma, Indonesia
Collaborator
Source ClinicalTrials.gov