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Could a Virus-Like particle vaccine outsmart polio?

NCT ID NCT06577298

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial is testing an experimental vaccine made from virus-like particles (VLPs) that mimic polio viruses without causing disease. It aims to see if this vaccine is safe and triggers a strong immune response in healthy infants starting at 6 weeks old and toddlers aged 12-18 months. Participants receive either one of three doses of the VLP vaccine or a standard inactivated polio vaccine, with multiple doses given over several months. The study compares side effects and antibody levels to determine the best dose for future use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A virus-like particle (VLP) based vaccine against poliomyelitis, given in different doses with an adjuvant, compared to an inactivated polio vaccine (IPV).
What this could lead to
If successful, this could provide a safer, more effective polio vaccine option that does not rely on live or inactivated whole viruses, potentially improving global polio eradication efforts.
What could go wrong
This is an early-phase trial, so the vaccine may not produce a strong enough immune response or may cause unexpected side effects. Results in infants and toddlers may not predict effectiveness in broader populations.
Why investors are watching

CanSino Biologics is testing a new polio vaccine that uses virus-like particles instead of the traditional live or inactivated virus. This trial checks the vaccine's safety and immune response in infants and toddlers, and a positive result could give the small company a new product in a global market with steady demand. Because CanSino is small, this single trial's outcome can meaningfully affect its value and reputation.

If it works: A successful readout could position CanSino as a leader in next-generation polio vaccines, potentially opening partnerships or licensing deals with larger organizations. It may also validate the company's VLP platform for other vaccines, broadening its pipeline.

If it fails: The trial could fail to show adequate immune response or safety, which would set back the program and hurt investor confidence. Trials at this stage often fail, and any delay in enrollment or dosing could also weigh on the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

480 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 weeks to 18 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 .

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dr. Cipto Mangunkusumo Hospital

    Jakarta, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.