Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Launched by PATH · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two types of new oral poliovirus vaccines, known as trivalent (tnOPV) and bivalent (bOPV), to see how safe and well they are tolerated by healthy adults, young children, and newborns. The researchers want to find out if these vaccines can help the body build protection against poliovirus by comparing the immune response of those who receive the new vaccines to those who receive standard vaccines. The study will include healthy participants of all ages, from newborns to adults up to 45 years old, who are willing to follow the study's requirements.

To participate, individuals must be healthy and have no significant medical issues. For adults, they should be between 18 and 45 years old, while children must be between 1 and 5 years old, and newborns should be just a few days old. Participants can expect to receive a series of vaccinations and will be monitored for any side effects. It's important to note that individuals living with children under 10 without complete poliovirus vaccination, those with certain medical conditions, or those who have recently received other vaccines may not be eligible. Overall, this trial aims to help improve poliovirus vaccines to better protect against this disease.

Gender

ALL

Eligibility criteria

• • Inclusion 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. Participant or parent of the participant is willing and able to provide written informed consent prior to performance of any study-specific procedure.
• • 3. Resides and plans to remain in study area and participants and parent, when applicable, 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).
• Inclusion Criteria for Cohort 1 participants only:
• • 4. Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment.
• • 5. If female and of childbearing potential\*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination \[if screening occurs within 24 hours prior to vaccination, a single negative pregnancy test is acceptable\]), agreeing to not become pregnant through other means (e.g., artificial insemination and IVF) and have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception\*\* for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination.
• • 6. Born and raised in Bangladesh in 1990 or later; if born before 1990 or not born and raised in Bangladesh, has documentation of a complete poliomyelitis immunization series containing OPV or IPV.
• Inclusion Criteria for Cohort 2 participants only:
• • 7. Male or female child from 1 to less than 5 years of age at the time of enrollment (from the first birthday up to the day prior to the fifth birthday).
• • 8. Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing bOPV ± IPV, with last dose received more than 3 months prior to initial study vaccination.
• Inclusion Criteria for Cohort 3 participants only:
• • 9. Male or female newborn neonate (day of birth+ 3-day window), at the time of initial study vaccination.
• • 10. Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based upon documentation or parental history.
• • 11. Agreement to receive polio EPI vaccines under a modified schedule.
• • Exclusion Criteria
• Exclusion Criteria for all participants (unless otherwise specified):
• • 1. 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 based on the vaccination records at the time of study vaccine administration. For household members younger than 10 years of age-appropriate vaccination is a complete series of at least three doses of OPV.
• • 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).
• • 3. 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).
• • 4. Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study.
• • 5. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
• • 6. Moderate or severe (grade ≥ 2) acute illness including vomiting, diarrhea at the time of enrollment/first study vaccination - temporary exclusion.
• • 7. Presence of fever within the 72 hours of the day of enrollment/first study vaccination (oral temperature ≥38.0˚C for Cohort 1; axillary temperature ≥37.5˚C for Cohorts 2 and 3) or any antipyretic use within past 24 hours - temporary exclusion for Cohorts 1 and 2.
• • 8. Evidence of a clinically significant major congenital or genetic defect as judged by the investigator.
• • 9. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (\> 0.5mg/kg/day or 20 mg/day of prednisolone (or equivalent) within 6 months prior to first study vaccine dose. Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the young child).
• • 10. Participation in another investigational product (drug or vaccine, including prior polio vaccine trials) 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 to the first administration of study vaccine, or planned participation in another investigational product clinical trial during the study period.
• • 11. Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned during the study period.
• • 12. Participant or parent, when applicable, has any condition that in the opinion of the investigator would increase the participant's health risks in 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 1 participants:
• • 13. Receipt of polio vaccine within 12 months before the start of the study.
• • 14. Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel.
• • 15. Will have household direct or close professional contact during the study with pregnant women.
• • 16. Will have household direct or close professional (e.g., neonatal nurses) contact during the study with children less than 2 years of age or with individuals who are encopretic (i.e., soiling of underwear with stool by children who are past the age of toilet training or other individuals, including adults, with fecal incontinence).
• • 17. Will have professional handling of food, catering, or food production activities during the study.
• Exclusion Criteria for Cohort 2 participants:
• • 18. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.
• • 19. Presence of severe malnutrition \[weight-for-length/height z-score \<-3SD median (per WHO published child growth standards)\]-temporary exclusion if marginal and subsequently gains weight.
• Exclusion Criteria for Cohort 3 participants:
• • 20. Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth or by the time of enrollment
• • 21. Premature birth (less than 37 weeks gestation).
• • 22. From multiple birth (due to increased risk of OPV transmissions between siblings).