NCT06577298

A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers

A Phase I/II Randomized, Double-blind, Positive-controlled Dose-exploration Study to Evaluate the Safety and Immunogenicity of a Virus-like Particle (VLP) Based Vaccine Against Poliomyelitis (VLP-Polio) in Infants From 6 Weeks of Age and Toddlers 12-18 Months of Age

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 6 Weeks – 18 Months
• Healthy volunteers: Accepted

Summary

This is a phase I/II randomized, double-blind, and positive-controlled study. Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio (Dose H) or control vaccine in a ratio of 3:1. The phase I infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Phase II infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Each infant participant will be administrated 3 doses of the assigned vaccine with 28 days apart, and the booster dose will be given when the infant is 12-18 months old. Enrollment of Phase I and Phase II will be staggered in descending order of age group but ascending order of dosing levels. Blood and mucosal samples will be collected for immunogenicity evaluation over the time course of the study.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose	4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
BIOLOGICAL	VLP-Polio medium dose	4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
BIOLOGICAL	VLP-Polio high dose	1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
BIOLOGICAL	Vaccine Poliomyelitis Inactivated (IPV)	1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants

Timeline

• Start date: 2024-12-19
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2024-08-29
• Last updated: 2025-07-04

Locations

1 site across 1 country: Indonesia