VLP-based trivalent polio vaccine safety and immune response 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

This trial tests a new VLP-based trivalent polio vaccine in infants and toddlers to see if it is safe and induces protective immune responses.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 6 Weeks to 18 Months
• Sex: All
• Sponsor: CanSino Biologics Inc. (Industry-sponsored)
• Locations: 1 site (Jakarta)
• Trial ID: NCT06577298 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, positive-controlled Phase I/II study of a recombinant trivalent VLP-Polio vaccine in two age groups. Toddlers (12–18 months) in the Phase I toddler cohort receive one dose of high-dose VLP-Polio or control in a 3:1 ratio, while infants (6 weeks to 2 months) are randomized across low-adjuvant, medium, high, or control arms with a 3:1 allocation and receive three doses 28 days apart plus a booster at 12–18 months. Blood and mucosal samples will be collected to measure systemic and mucosal immune responses and safety outcomes. Enrollment is staggered by age and dose level with safety monitoring between stages.

Who should consider this trial

Good fit: Ideal candidates are healthy infants aged 6 weeks to 2 months who have not received any polio vaccine and healthy toddlers aged 12–18 months who have completed primary polio immunization per the national schedule, with parental consent and ability to attend follow-up.

Not a fit: Children with prior polio disease, toddlers who received a polio vaccine within the past five months, infants born before 37 weeks' gestation, or those with low birth weight (<2500 g at birth or <3500 g at enrollment) are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the vaccine could provide a safe, non-replicating trivalent polio option that elicits systemic and mucosal immunity in young children and broaden available polio vaccines.

How similar studies have performed: Inactivated and oral polio vaccines are well established, and VLP vaccine platforms have shown promise in preclinical and some clinical settings, but a VLP-based trivalent polio vaccine in infants remains relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

Exclusion criteria for the first dose:

* 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.
* Participation in other interventional studies within 28 days prior to screening and/or during study participation.
* Household member or sibling who has received or is scheduled to receive OPV in the previous 3 months until 5 weeks after the third dose of the primary immunization series.
* The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel.
* History or current evidence of any condition or therapy which might confound the results of the study, interfere with the participant's participation for the full duration of the study, indicate suspected diseases, or is not in the best interest of the participants to participate, in the opinion of the treating investigator.
* Family history of any medical conditions, that in the investigating doctor's opinion, could affect the trial outcomes.
* Any reason or condition the investigator considers sufficient to make a participant ineligible for participation in the study.

Exclusion criteria for the subsequent doses:

* Severe allergic reaction after the previous vaccination.
* Serious adverse events caused by the previous vaccination.
* Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator.
* Other reasons for exclusion considered by the investigating doctor .

Where this trial is running

Jakarta

• Dr. Cipto Mangunkusumo Hospital — Jakarta, Indonesia (Recruiting)

Study contacts

• Principal investigator: Nina Putri, Dr — Dr. Cipto Mangunkusumo Hospital
• Study coordinator: Xiaoyuan Zhao

Conditions Poliomyelitis; Vaccine; Trivalent; Immunogenicity; Safety; 12-18 months toddlers; 2 months infants