A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
NCT Number: NCT06577298
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Poliomyelitis
Interventions: BIOLOGICAL: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose|BIOLOGICAL: VLP-Polio medium dose|BIOLOGICAL: VLP-Polio high dose|BIOLOGICAL: Vaccine Poliomyelitis Inactivated (IPV)
Sponsor: CanSino Biologics Inc.
Sex: ALL
Age: CHILD
Enrollment: 480
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-12
Locations: Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

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.

Primary Outcome Measures: Phase I: Percentage of participants with solicited adverse events (AEs), Within 7 days after each vaccination|Phase II: Percentage of participants with solicited adverse events (AEs), Within 7 days after each vaccination|Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3, Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Secondary Outcome Measures: Phase I: Percentage of participants with unsolicited AEs, Within 28 days after each vaccination|Phase I: Percentage of participants with solicited AEs, Within 30 minutes after each vaccination|Phase I: Percentage of participants experiencing serious adverse events (SAEs), Through study completion, Toddlers about 6 months, Infant about 20-22 months.|Phase I: Geometric mean titer (GMT) of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers, Day 0 before vaccination and on Day 28 after the vaccination|Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers, Day 0 before vaccination and on Day 28 after the vaccination|Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers, Day 0 before vaccination and on Day 28 after the vaccination|Phase I: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants, Day 0 before vaccination and on Day 28 after the 3rd dose vaccination|Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants, Day 0 before vaccination and on Day 28 after the 3rd dose vaccination|Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants, Day 0 before vaccination and on Day 28 after the 3rd dose vaccination|Phase II: Percentage of participants with unsolicited AEs, Within 28 days after each vaccination|Phase II: Percentage of participants with solicited AEs, Within 30 minutes after each vaccination|Phase II: Percentage of participants experiencing SAEs, Through study completion, Toddlers about 6 months, Infant about 20-22 months.|Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3, Day 0 before vaccination and on Day 28 after the 3rd dose vaccination|Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3, Day 0 before vaccination and on Day 28 after the 3rd dose vaccination|Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants., Month 6 after the 3rd dose vaccination|Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants., Month 6 after the 3rd dose vaccination|Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants., Month 6 after the 3rd dose vaccination
Other Outcome Measures: Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants., Day 0 before booster vaccination, on Day 28 and Month 6 after the booster vaccination|Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants., Day 0 before booster vaccination, on Day 28 and Month 6 after the booster vaccination|Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants., Day 0 before booster vaccination, on Day 28 and Month 6 after the booster vaccination|Phase II: GMT of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in stool samples in extended immunogenicity subgroup participants, Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination|Phase II: GMI (geometric mean fold increase) of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in stool samples in extended immunogenicity subgroup participants, Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination|Phase II: GMT of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in nasal samples in extended immunogenicity subgroup participants, Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination|Phase II: GMI of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in nasal samples in extended immunogenicity subgroup participants, Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination