Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines (NCT06137664) | Clinical Trial Compass
RecruitingPhase 1/2
Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
Bangladesh2,400 participantsStarted 2024-11-20
Plain-language summary
The main objectives of this study are to :
* evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines;
* evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control.
* compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;
* evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Who can participate
Age range0 Days – 45 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Participant or parent of the participant is willing and able to provide written informed consent prior to performance of any study-specific procedure.
✓. 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).
✓. Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment.
✓. 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.
✓. 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.
What they're measuring
1
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From the time of first study vaccination through the end of the study (197 days)
2
Number of Participants with Solicited Adverse Events (AEs) for 7 Days After Each Vaccination
Timeframe: 7 days (day of vaccination and 6 following days) after each vaccination
3
Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination.
Timeframe: 28 days (day of vaccination and 27 following days) after each vaccination
4
Neonates: Seroconversion Rate of Types 1, 2, and 3 Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
Timeframe: Baseline and 28 days following the last vaccination (week 18)
5
Neonates: Seroconversion Rate of Types 1, 2, and 1 & 2 Combined Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
Timeframe: Baseline and 28 days following the last vaccination (week 18)
✓. 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).
✓. 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.
Exclusion criteria
✕. 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.
✕. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
✕. 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).
✕. Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study.
✕. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
✕. Moderate or severe (grade ≥ 2) acute illness including vomiting, diarrhea at the time of enrollment/first study vaccination - temporary exclusion.
✕. 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.
✕. Evidence of a clinically significant major congenital or genetic defect as judged by the investigator.