Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama

Launched by PATH · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new oral vaccine for poliomyelitis, known as nOPV3, to see if it is safe and effective in young children, infants, and newborns. The researchers want to find out how well the vaccine works (its immunogenicity), if there are any side effects (safety and tolerability), and if the virus from the vaccine can be passed in stool. They will compare the results of the new vaccine against an existing vaccine called mOPV3.

To participate, children must be healthy and meet specific age requirements—ranging from newborns to children under five years old. Parents or guardians need to provide consent and agree to follow the study's schedule for vaccinations. Participants can expect to receive the vaccine and will be monitored for any reactions and how well their bodies respond to it. It's important to note that certain health conditions or recent vaccinations might exclude a child from the study. This trial is currently looking for participants in Panama, and it aims to gather important information to help improve polio vaccinations in the future.

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. 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(s) or guardian(s) 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(s) or guardian(s) agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol adjusted schedule.
• Inclusion Criteria for cohort 1 participants only:
• • 1. Male or female child from ≥1 to \<5 years-of-age at the time of initial study vaccination.
• • 2. Based on available documentation or parental/guardian(s) report, previously completed the primary poliomyelitis immunization series for the jurisdiction, with last dose received more than 28 days prior to initial study vaccination.
• Inclusion Criteria for cohort 2 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 parental/guardian(s) report or documentation.
• Inclusion Criteria for Cohort 3 participants only:
• • 1. Male or female newborn (1st day of life + 3-day window), at the time of initial study vaccination.
• • 2. Prior to study vaccination has received no doses of IPV or OPV vaccine, based on no evidence of such vaccination per available parental/guardian(s) report or documentation.
• • Exclusion Criteria
• 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 appropriate vaccination is complete series of the primary poliomyelitis immunization series for the jurisdiction.
• • 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 three 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 (see Appendix II: Severity Grading Tables). 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). If resolved in 48 hrs., can be enrolled.
• • 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. 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).
• • 8. Receipt of any systemic immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member.
• • 9. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
• • 10. 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.
• • 11. 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 to the first administration of study vaccine, or planned use during the study period.
• • 12. 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.
• • 13. Parent(s) or guardian(s) or participant 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 2 and 3 participants only:
• • 1. Premature birth (less than 37 weeks gestation or less than 2500 grams birth weight).
• • 2. From multiple birth (due to increased risk of OPV transmissions between siblings).