Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Poliomyelitis Clinical Trial

Official title: A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Age De-escalation, Dose Combination Ranging Study to Assess the Safety and Immunogenicity of Co-administered Novel Live Attenuated Trivalent Oral Poliomyelitis Vaccine in Healthy Adults, Young Children, and Neonates and Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines 1 and 2 in Neonates in Bangladesh

Status Not yet recruiting

Clinical Trial Summary

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 antibody responses among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;

• evaluate the type-specific and overall antibody response among healthy neonates following 4 doses of combined nOPV1+nOPV2.

Clinical Trial Description

This trial will use co-administered novel monovalent types 1, 2, and 3 vaccines to simulate administration of a potential trivalent vaccine and compare to the active control bOPV (bivalent Sabin types 1 and 3) and will be conducted at a single clinical center.

The study population will include healthy adults (≥18 to ≤45 years old) who have previously completed their full routine polio immunization series, healthy young children (≥1 to <5 years old) who have completed their full routine polio immunization series and healthy neonates (day of birth+3 days), who have not received any polio vaccination.

Enrollment in this study will be staggered into two stages and three age-descending cohorts.

Stage 1 will consist of an age-descension/dose escalation approach from adults to young children (Cohorts 1 and 2). Enrollment will begin with Cohort 1, in which 100 adults will be randomly allocated in a 1:1 ratio to Groups 1 and 2. Following a Protocol Safety Review Team (PSRT) review of the study Day 29 safety data of the adults in Cohort 1, and the absence of any safety concerns, 200 young children in Cohort 2 will be randomly allocated in a 1:1:1:1 ratio to Groups 3, 4, 5, and 6, respectively.

The study will move into Stage 2 based on PSRT review of safety data from Stage 1 and based on the results from three other novel oral poliovirus vaccine studies (CVIA 093 [NCT05644184], CVIA 101 [NCT05654467] and CVIA 076 [NCT04529538]).

Stage 2 will consist of dose exploration in neonates (Cohort 3). In Cohort 3, Groups 7-13, 2100 neonates will be randomly allocated in a 3:3:3:3:3:3:2:1 ratio, respectively. ;

Related Conditions & MeSH terms

• Poliomyelitis

• NCT number: NCT06137664
• Study type: Interventional
• Source: PATH
• Contact: Nicole Grunenberg, MD
• Phone: 206-285-3500
• Email: ngrunenberg@path.org
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 29, 2025
• Completion date: December 15, 2027