Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

Launched by PATH · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new oral vaccine for polio called nOPV1, which is being tested in Bangladesh. The main goals of the study are to see how safe the vaccine is and how well it works in building immunity against polio in young children, infants, and newborns. The trial will involve a total of 2,012 healthy participants, including 192 young children (ages 1-5), 720 infants (around 6 weeks old), and 1,100 newborns (up to 3 days old). The researchers will also look at how the vaccine behaves in the body after it is given and if there are any risks associated with it.

To be eligible for the trial, participants must be healthy and live in the study area, with parents or guardians who can provide consent. Young children should have previously received polio vaccinations, while infants and newborns must not have received any polio vaccines yet. Participants can expect to receive the new vaccine and will be monitored for its effects. It’s important to note that there are specific health criteria and household conditions that could exclude someone from joining, mainly to ensure the safety of all participants. If you think your child might qualify and you’re interested, you can discuss this with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for all participants:
• • 1. 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
• • 2. Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure
• • 3. 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)
• • 4. Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule
• Inclusion Criteria for Cohort 1 (young children) participants only:
• • 1. Male or female child from 1 to less than 5 years of age at the time of initial study vaccination
• • 2. 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 vaccination
• Inclusion Criteria for Cohort 2 (infants) participants only:
• • 1. 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
• • 2. Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation.
• Inclusion Criteria for Cohort 3 (neonates) participants only:
• • 1. Male or female newborn (1st day of life+ 3-day window, inclusive), at the time of initial study vaccination
• • 2. 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.
• Exclusion Criteria for all participants:
• • 1. 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 to poliovirus vaccines at the time of study vaccine administration. For household members younger than 10 years of age, "age appropriate" vaccination is complete series of trivalent Oral Poliovirus Vaccine (tOPV) or at least three doses of bivalent (types 1 and 3) Oral Poliovirus Vaccine (bOPV) plus a booster fractional dose of IPV (fractional dose Inactivated Polio Vaccine; fIPV). Note: A vaccination series of tOPV or at least three doses of bOPV with our without a booster fractional dose of IPV will be considered sufficient.
• • 2. 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 administration.
• • 3. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.
• • 4. 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.
• • 5. Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2)
• • 6. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)
• • 7. Evidence of a clinically significant congenital or genetic defect as judged by the investigator
• • 8. 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 (unless indicative of a significant chronic illness otherwise excluding the infant/young child)
• • 9. 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 same compound)
• • 10. 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
• • 11. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection
• • 12. 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.
• • 13. 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 prior tot he first administration of study vaccine, or planned use during the study period.
• • 14. 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.
• • 15. 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 (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments.)
• Exclusion Criteria for Cohort 2 \& 3 participants only:
• • 1. 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.
• • 2. Premature birth (less than 37 weeks gestation)
• • 3. From multiple birth (due to increased risk of OPV transmission between siblings)

Trial Officials