Birth-dose nOPV2 in IPV-primed newborns for poliovirus type 2 transmission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial evaluates the transmissibility of poliovirus type-2 in stool samples from newborns given an nOPV2 dose at birth and primed with IPV at 6, 10, and 14 weeks. Stool is tested before and after a controlled nOPV2 challenge to compare viral shedding across three groups. The study builds on prior immunogenic data showing nOPV2 is safe and capable of eliciting neutralizing antibodies, and aims to clarify its effect on virus transmission in a real-world setting. Eligible participants are healthy term newborns with parental consent, recruited in a defined geographic area and followed through the vaccination schedule and sampling timepoints.

Why it matters

Who can join: the full rules

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).

Where it's running

• icddr,b - Matlab Health Research Centre
  Chāndpur, Dhaka Division, Bangladesh Recruiting

Study contacts

• Principal investigator: Khaelqu Zaman, Dr. — International Centre for Diarrhoeal Disease Research, Bangladesh
• Study coordinator: Ricardo Rüttimann, Dr.
• Email: rruttimann@fidec-online.org
• Phone: +54 9 11 6118-8536

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.