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New treatment option for Poliomyelitis
Official title Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
ClinicalTrials.gov ID: NCT05644184
What this study is testing
What is Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)?
Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for poliomyelitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 4. Healthy volunteers may be eligible.
You may be able to join if
- for all participants:
- Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical...
- Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure
- Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed...
- Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule for Cohort 1...
You likely can't join if
- for all participants:
- For all participants, the presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who...
- For all participants, having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the...
- Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine...
- Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination - temporary exclusion. Participant with mild (grade 1)...
- Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2)
See the full eligibility criteria
Who can join
- for all participants:
- Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator
- Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure
- Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator)
- Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule for Cohort 1 (young children) participants only:
- Male or female child from 1 to less than 5 years of age at the time of initial study vaccination
- Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing OPV (may have also received IPV), with last dose received more than 3 months prior to initial study...
- Male or female infant expected to be 6 weeks of age (43rd to 49th day of life [with day of birth being the first day of life], inclusive+ 6-day window), at the time of initial study vaccination
- Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation. for Cohort 3 (neonates) participants only:
- Male or female newborn (1st day of life+ 3-day window, inclusive), at the time of initial study vaccination
- Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based on no evidence of such vaccination per available documentation.
What rules you out
- for all participants:
- For all participants, the presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect...
- For all participants, having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine...
- Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.
- Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination - temporary exclusion. Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator.
- Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2)
- A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)
- Evidence of a clinically significant congenital or genetic defect as judged by the investigator
- History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (\> 0.5mg/kg/day of prednisolone (or equivalent)). Topical and inhaler steroids are permitted...
- Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof/in the same building rather than in the...
- Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study of study participants or a household member
- Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection
- Presence of sever malnutrition [weight-for-length/height z-score greater than or equal to -3 SD median (per WHO published growth standards)] - temporary exclusion if marginal and subsequently gains weight.
- Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days...
- Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned use during the study period.
- Parent or participant has any condition that in the opinion of the investigator would increase the participant's health risks in the study participation or would increase the risk of not achieving the study's objectives...
- Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500g (up to and including 2499b) at the time of birth or by the time of enrolment.
- Premature birth (less than 37 weeks gestation)
- From multiple birth (due to increased risk of OPV transmission between siblings)
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 4 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.