Can a Birth-Dose polio vaccine block the virus in Babies' guts?
NCT ID NCT07010822
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether a new oral polio vaccine called nOPV2, given at birth, helps infants block type 2 poliovirus in their intestines. The trial enrolls 740 healthy newborns who have received standard injected polio vaccines. Scientists will check stool samples for signs of the virus after a later nOPV2 challenge dose to see if the birth dose builds gut immunity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a new oral polio vaccine called nOPV2
- What this could lead to
- If it works, giving nOPV2 at birth could help infants stop type 2 poliovirus from spreading through their gut, which may reduce silent transmission in communities.
- What could go wrong
- This is a phase III trial, so the approach is still being tested. The vaccine may not produce the gut immunity researchers look for, and results in newborns may not match those in older children.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 740 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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1 day to 7 days
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. Newborn infants of maximum 1 week of age 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 medical history and physical examination. 3. Written informed consent obtained from both parents or legal guardian(s) as per country regulations. 4. Resides in the area and parents willing to adhere to all study procedures. Exclusion Criteria: 1. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the participant's household. 2. Household member who has receive any novel OPV 1 month before birth of this study's participant up through 1 month post-last-dose. 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 (≥37.5 °C) 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. Participant 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 participant. 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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icddr,b - Matlab Health Research Centre
RECRUITINGChāndpur, Dhaka Division, Bangladesh
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