Actively Recruiting
A Phase 2, Randomized, Observer-blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess Safety and Immunogenicity of a Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Bangladesh
Led by PATH · Updated on 2026-01-09
2232
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
PATH
Lead Sponsor
B
Bill and Melinda Gates Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new oral polio type 1 vaccine called nOPV1 to study its safety, immune response, virus shedding, and potential nerve-related effects compared to the existing Sabin monovalent type 1 vaccine (mOPV1). This study involves healthy children, infants, and newborns to understand how this vaccine performs in these different pediatric age groups. This trial includes 15 groups with participants divided into three age cohorts: young children aged 1 to under 5 years who have completed routine polio vaccines, infants around 6 weeks old receiving one dose of inactivated polio vaccine followed by nOPV1 or mOPV1, and newborns vaccinated within 3 days of birth. Participants will receive two or three doses of the study vaccines at varying dose levels, with doses spaced 28 days apart. Infants will also receive a challenge dose of mOPV to test virus shedding reduction. Participants will be followed for up to 32 weeks, with assessments including monitoring for serious and mild side effects, measuring immune response by blood tests, and analyzing stool samples for virus shedding. Some infants will have additional tests for nerve effects of shed viruses. The study will collect data from the first vaccination through the follow-up period to evaluate vaccine safety and immune protection.
CONDITIONS
Brief Title
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants with no significant medical conditions as determined by medical assessment
- Parent or guardian able and willing to provide written informed consent
- Participant resides in the study area and can attend all study visits and procedures
- Parent agrees to follow the study's routine immunization schedule
- Young children aged 1 to less than 5 years who completed a 3 or 4 dose polio vaccine series more than 3 months before study start
- Infants expected to be 6 weeks old at initial vaccination with no prior polio vaccination
- Neonates within 3 days of birth with no prior polio or rotavirus vaccination
You will not qualify if you...
- Household members under 10 years old without complete polio vaccination
- Household member received oral polio vaccine in the 3 months before study vaccination
- Attendance at daycare or preschool during the study until one month after last vaccine dose
- Moderate or severe acute illness or fever (axillary temperature 6EAC) at enrollment
- Known allergy or intolerance to vaccine components including certain antibiotics
- Significant congenital or genetic defects
- Chronic immunosuppressant medication use (over 14 days), except certain steroids
- Known or suspected immunodeficiency in participant or household member
- Recent or planned use of immune-modifying drugs by participant or household member
- Known or suspected bleeding disorder posing risk for injections or blood draws
- Severe malnutrition (weight-for-length/height z-score 1-3 SD), temporary exclusion if improving
- Participation in another investigational study within 30 days prior to enrollment
- Recent blood transfusion or immunoglobulin within 12 months before vaccination
- Any condition increasing health risks or interfering with study requirements
- For infants and neonates: low birth weight under 2500g, premature birth under 37 weeks gestation, or multiple births due to increased transmission risk of oral vaccine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 13 weeks depending on cohort and dosing schedule
Participants receive two or three oral doses of the novel poliomyelitis vaccine or the control vaccine, with doses spaced 28 days apart. Infants also receive one dose of inactivated poliomyelitis vaccine on Day 1, followed by vaccine doses and a challenge dose several weeks later.
2 to 3 vaccination visits plus 1 challenge vaccination visit
Duration - Up to 28 weeks for young children and neonates, up to 32 weeks for infants
Participants are followed for safety and immunogenicity assessments for up to 28 weeks (young children and neonates) or 32 weeks (infants) after their first vaccination.
Multiple follow-up visits over weeks following vaccination
Trial Site Locations
Total: 1 location
1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh, 1212
Actively Recruiting
Research Team
T
Tushar Tewari, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
15
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