Actively Recruiting
A Phase 1/2, Randomized, Observer-Blind, Active-Controlled Study to Assess Safety and Immune Response of Novel Trivalent Oral Poliovirus Vaccine in Healthy Adults, Young Children, and Neonates in Bangladesh
Led by PATH · Updated on 2025-06-03
2400
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
P
PATH
Lead Sponsor
B
Bio Farma, Indonesia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and immune response of new trivalent and bivalent oral poliovirus vaccines in healthy adults, young children, and newborns. This study aims to compare novel oral poliovirus vaccines (types 1, 2, and 3) with the existing bivalent vaccine in different age groups, including neonates who have not received prior polio vaccination. The trial is conducted in phases and includes age-descending cohorts to carefully assess vaccine effects across ages. The study involves multiple groups receiving different combinations and doses of novel oral poliovirus vaccines or the control bivalent vaccine. Adults and young children receive two doses on Day 1 and Day 29, while neonates receive four doses at birth, week 6, week 10, and week 14. Vaccines include live attenuated types 1, 2, and 3 poliovirus at varied doses, administered orally. The study is randomized with groups assigned to experimental or active comparator vaccines. Participants will undergo safety monitoring for adverse events after each vaccination, with follow-up up to 197 days. Researchers will measure poliovirus neutralizing antibody responses to assess immune protection over time. Blood samples and clinical assessments will be performed at scheduled visits to evaluate vaccine safety, immune response, and any serious or minor adverse events. The study duration varies by cohort but includes detailed monitoring through vaccination and follow-up periods.
CONDITIONS
Brief Title
Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy individuals without significant medical conditions or congenital anomalies
- Willing and able to provide written informed consent
- Planning to remain in study area and able to attend all study visits
- Adults aged 18 to 45 years (Cohort 1)
- Females of childbearing potential in Cohort 1 must not be pregnant or breastfeeding and agree to use contraception
- Born and raised in Bangladesh from 1990 or later, or have documented complete polio immunization if born earlier
- Children aged 1 to less than 5 years with documented primary polio immunization series completed over 3 months prior (Cohort 2)
- Newborn neonates within 3 days of birth who have not received any polio or rotavirus vaccines (Cohort 3)
- Agreement to receive polio vaccines under a modified schedule (Cohort 3)
You will not qualify if you...
- Having anyone under 10 years old in the household without complete age-appropriate polio vaccination
- Allergy or intolerance to vaccine components including certain antibiotics
- Known or suspected immunosuppressive or immunodeficiency conditions in participant or household
- Use of immunomodifying or immunosuppressant drugs within 6 months prior or planned during study
- Known bleeding disorders posing risk for injections or blood draws
- Moderate or severe acute illness or fever around enrollment
- Major congenital or genetic defects
- Chronic use of immunosuppressants including corticosteroids (except topical or inhaled unless indicating chronic illness)
- Recent participation in other investigational drug or vaccine trials
- Recent blood transfusions or immunoglobulin treatments
- Conditions increasing health risks or interfering with study adherence
- Adults with recent polio vaccine within 12 months, certain gastrointestinal diseases, or specific household/professional contacts
- Children attending daycare or preschool during study
- Children with severe malnutrition
- Newborns with low birth weight, premature birth, or multiple births
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 14 weeks depending on cohort
Participants receive oral poliomyelitis vaccines according to their age cohort and assigned group. Adults and young children receive two doses on Day 1 and Day 29. Neonates receive four doses at birth, week 6, week 10, and week 14 of life.
2 visits for adults and young children; 4 visits for neonates
Duration - Up to 18 weeks from first vaccination
Participants are monitored for safety and immune response after vaccination, including assessment of adverse events and antibody levels.
Multiple visits aligned with vaccination schedule and immune response assessments
Trial Site Locations
Total: 2 locations
1
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh, 1212
Not Yet Recruiting
2
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
Actively Recruiting
Research Team
N
Nicole Grunenberg, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
14
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