Can a new polio vaccine stop the virus at the throat?

NCT ID NCT05677256

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests how well two polio vaccines protect the throat against poliovirus type-2. Healthy infants receive either bivalent oral polio vaccine (bOPV) or inactivated polio vaccine (IPV) in the first months of life. At 18 weeks, all infants get a dose of a newer oral polio vaccine (nOPV2) as a challenge. Researchers then measure virus shedding and antibodies in throat samples over four weeks to compare mucosal immunity.

What this could mean

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

Active substance
novel oral polio vaccine type 2 (nOPV2) as a challenge dose
What this could lead to
If throat immunity differs between vaccine types, this could guide future polio vaccination strategies to better block virus spread.
What could go wrong
This is a phase 4 study in healthy infants, and results may not reflect real-world transmission. The challenge vaccine is safe but may cause mild side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

501 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

5 to 8 weeks

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: 1. Infants aged 6 to 8 weeks with birth weight \>2,500 g. 2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination. 3. Written informed consent obtained from both parents or legal guardian(s) as per country regulations. Exclusion Criteria: 1. Infants who have received previous vaccination against poliomyelitis. 2. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household. 3. Family history of congenital or hereditary immunodeficiency. 4. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 5. Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines. 6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV) 7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. 8. Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.). 9. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject. 10. Infants from multiple births or born prematurely (\< 37 weeks of gestation).

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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

  • International Centre for Diarrhoeal Diseases Research

    Dhaka, 1212, Bangladesh

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