Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Vaccine tolerability, Vaccine safety, Vaccine reactogenicity, Vaccine viral shedding, Vaccine immunogenicity
Eligibility Criteria
Inclusion Criteria for all participants: 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 Inclusion Criteria for Cohort 1 (young children) participants only: 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 Inclusion Criteria for Cohort 2 (infants) participants only: 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. Inclusion Criteria for Cohort 3 (neonates) participants only: 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. Exclusion Criteria for all participants: 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). 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. Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination - temporary exclusion. Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator. Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2) 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 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
Sites / Locations
- International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Active Comparator
Group 1: Young Children, nOPV1 10^5.5 CCID50
Group 3: Young Children, nOPV1 10^6.0 CCID50
Group 5: Young Children, nOPV1 10^6.5 CCID50
Groups 2, 4 and 6: Young Children, mOPV1
Group 7: Infants, nOPV1 10^5.5 CCID50
Group 9: Infants, nOPV1 10^6.0 CCID50
Group 11: Infants, nOPV1 10^6.5 CCID50
Groups 8, 10 and 12: Infants, mOPV1
Group 13: Neonates, nOPV1 10^5.5 CCID50
Group 15: Neonates, nOPV1 10^6.0 CCID50
Group 17: Neonates, nOPV1 10^6.5 CCID50
Groups 14, 16 and 18: Neonates, mOPV
48 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
48 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
48 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
48 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
96 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.
96 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.
48 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.
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
330 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^5.5 CCID50 on Day 1 and Day 29.
330 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^6.0 CCID50 on Day 1 and Day 29.
165 neonates (day of birth + 3 days) will receive 2 doses of nOPV1 at a dose level of 10^6.5 CCID50 on Day 1 and Day 29.
330 neonates (day of birth + 3 days) will receive 2 doses of mOPV1 at a dose level of ≥ 10^6.0 CCID50 on Day 1 and Day 29