A Phase 2, Randomized, Observer-blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess Safety and Immunogenicity of a Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Bangladesh

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1100 subjects).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 4
Healthy Volunteers: t
View:

• 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

• 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

• 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.

• 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.

Locations
Other Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
RECRUITING
Dhaka
Contact Information
Primary
Tushar Tewari, MD
ttewari@path.org
+91 11 4064 0005
Time Frame
Start Date: 2023-03-27
Estimated Completion Date: 2026-05-15
Participants
Target number of participants: 2012
Treatments
Experimental: Group 1: Young Children, nOPV1 10^5.5 CCID50
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
Experimental: Group 3: Young Children, nOPV1 10^6.0 CCID50
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
Experimental: Group 5: Young Children, nOPV1 10^6.5 CCID50
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
Active_comparator: Groups 2, 4 and 6: Young Children, mOPV1
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
Experimental: Group 7: Infants, nOPV1 10^5.5 CCID50
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.
Experimental: Group 9: Infants, nOPV1 10^6.0 CCID50
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.
Experimental: Group 11: Infants, nOPV1 10^6.5 CCID50
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\^6.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Experimental: Group 11b: Infants, nOPV1 10^6.5 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Experimental: Group 13: Infants, nOPV1 10^7.0 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^7.0 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Experimental: Group 15: Infants, nOPV1 10^7.5 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^7.5 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Active_comparator: Groups 8, 10, 12, 12b, 14, 16: Infants mOPV1
192 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1 then 2 to 3 doses of mOPV1 at a dose level of ≥10\^6.0 CCID50 on Day 29, Day 57, Day 85 (groups 12b, 14 \& 16 only) and a challenge dose of mOPV on Day 113 (groups 8, 10 \& 12) on Day 141 (groups 12b, 14 \& 16)
Experimental: Group 17: Neonates, nOPV1 10^6.5 CCID50
330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 1, Day 29 \& Day 57
Experimental: Group 19: Neonates, nOPV1 10^7.0 CCID50
330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^7.0 CCID50 on Day 1, Day 29 \& Day 57
Experimental: Group 21: Neonates, nOPV1 10^7.5 CCID50
330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^7.5 CCID50 on Day 1, Day 29 \& Day 57
Active_comparator: Groups 18, 20 & 22: Neonates, mOPV1
330 neonates (day of birth +3 days) will receive 3 doses of mOPV1 at a dose level of ≥ 10\^6.0 CCID50 on Day 1, Day 29 \& Day 57
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation, PT Bio Farma, DiagnoSearch Life Sciences Pvt. Ltd.
Leads: PATH

This content was sourced from clinicaltrials.gov

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