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
1 other identifier
interventional
480
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 4, 2025
August 1, 2024
1.8 years
August 27, 2024
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (17)
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
- +12 more secondary outcomes
Other Outcomes (7)
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
- +4 more other outcomes
Study Arms (14)
Phase I, Toddler Group A, Experimental vaccine, High dose, IM
EXPERIMENTALOne dose of VLP-Polio on Day 0
Phase I, Toddler Group A, Control vaccine, IM
ACTIVE COMPARATOROne dose of IPV control on Day 0
Phase I, Infant Group B, Experimental vaccine, Low-adjuvant dose, IM
EXPERIMENTAL4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase I, Infant Group B, Control vaccine, IM
ACTIVE COMPARATOR4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase I, Infant Group C, Experimental vaccine, Medium dose, IM
EXPERIMENTAL4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase I, Infant Group C, Control vaccine, IM
ACTIVE COMPARATOR4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase I, Infant Group D, Experimental vaccine, High dose, IM
EXPERIMENTAL4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase I, Infant Group D, Control vaccine, IM
ACTIVE COMPARATOR4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase II, Infant Group E, Experimental vaccine, Low-adjuvant dose, IM
EXPERIMENTAL4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase II, Infant Group E, Control vaccine, IM
ACTIVE COMPARATOR4 dose of IPV vaccine on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase II, Infant Group F, Experimental vaccine, Medium dose, IM
EXPERIMENTAL4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase II, Infant Group F, Control vaccine, IM
ACTIVE COMPARATOR4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase II, Infant Group G, Experimental vaccine, High dose, IM
EXPERIMENTAL4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Phase II, Infant Group G, Control vaccine, IM
ACTIVE COMPARATOR4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Interventions
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Current polio disease or history of polio disease.
- Toddlers who have an interval of less than 5 months since their last dose of the polio vaccine.
- Infants born at \< 37 weeks of gestation.
- Children with a birth weight \< 2500g and a body weight \< 3500g at the time of enrollment.
- Body temperature ≥37.5°C (the visit may be rescheduled when this criterion is met).
- Have congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Any moderate or severe acute illness.
- Any abnormal vital signs.
- History of epilepsy, convulsions, or parent with congenital cognitive disability, dementia, or intellectual disabilities.
- Have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid treatment, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis).
- Received or plan to receive blood/plasma products or immunoglobulins throughout the study period or prior to study vaccination.
- History of serious adverse events and/or severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.
- History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia at birth).
- Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., history of pancreatic, liver, spleen, kidney disease or history of resection).
- Administration of other vaccines within 7 days.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Putri, Dr
Dr. Cipto Mangunkusumo Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2024
First Posted
August 29, 2024
Study Start
December 19, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 4, 2025
Record last verified: 2024-08