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
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: t
View:
• Healthy toddlers aged 12-18 months at the time of screening, and have completed primary immunization of polio vaccine according to the national government program in the first year of life.
• Healthy infants aged 6 weeks to 2 months (42 to 98 days, with the day of birth considered day of life 1), and who have not received any polio vaccines.
• Able to obtain written informed consent from parent(s) or legal guardian(s).
• Participants and their parents or legal guardian(s) can comply with trial procedures, are available for the duration of follow-up, and have a suitable telephone contact available.
Locations
Other Locations
Indonesia
Dr. Cipto Mangunkusumo Hospital
RECRUITING
Jakarta
Contact Information
Primary
Xiaoyuan Zhao
xiaoyuan.zhao@cansinotech.com
022-58213600-6051
Time Frame
Start Date:2024-12-19
Estimated Completion Date:2026-12
Participants
Target number of participants:480
Treatments
Experimental: Phase I, Toddler Group A, Experimental vaccine, High dose, IM
One dose of VLP-Polio on Day 0
Active_comparator: Phase I, Toddler Group A, Control vaccine, IM
One dose of IPV control on Day 0
Experimental: Phase I, Infant Group B, Experimental vaccine, Low-adjuvant dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Active_comparator: Phase I, Infant Group B, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Experimental: Phase I, Infant Group C, Experimental vaccine, Medium dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Active_comparator: Phase I, Infant Group C, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Experimental: Phase I, Infant Group D, Experimental vaccine, High dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Active_comparator: Phase I, Infant Group D, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Experimental: Phase II, Infant Group E, Experimental vaccine, Low-adjuvant dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Active_comparator: Phase II, Infant Group E, Control vaccine, IM
4 dose of IPV vaccine on Day 0, Day 28, Day 56 and Month 12-18 of age
Experimental: Phase II, Infant Group F, Experimental vaccine, Medium dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Active_comparator: Phase II, Infant Group F, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Experimental: Phase II, Infant Group G, Experimental vaccine, High dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Active_comparator: Phase II, Infant Group G, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age