Evaluation of a new oral polio vaccine in children

A Phase 2, Randomized, Observer-Blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess the Safety and Immunogenicity of a Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Panama

This study is testing a new oral polio vaccine in healthy young children to see if it is safe and works better than the current vaccine.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1532 (estimated)
• Ages: 1 Day to 4 Years
• Sex: All
• Sponsor: Path (Academic / other)
• Locations: 3 sites (Panama City and 2 other locations)
• Trial ID: NCT05654467 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety, tolerability, and immunogenicity of a novel oral poliomyelitis vaccine (nOPV3) compared to the existing Sabin monovalent type 3 vaccine (mOPV3) in healthy young children, infants, and neonates. The study is multicentered and involves 12 arms with staggered enrollment across three age cohorts. Participants will be monitored for vaccine safety, fecal shedding of the vaccine virus, and potential neurovirulence. The trial will only proceed to the next cohort if prior safety evaluations are satisfactory.

Who should consider this trial

Good fit: Ideal candidates include healthy young children aged 1 to less than 5 years, infants aged 6 weeks, and neonates who meet the study's inclusion criteria.

Not a fit: Patients with significant medical conditions or congenital anomalies may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could enhance protection against poliomyelitis in young children and reduce the risk of virus transmission.

How similar studies have performed: Previous studies of similar oral polio vaccines have shown promise, but this specific approach with nOPV3 is novel.

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).

Where this trial is running

Panama City and 2 other locations

• Cevaxin - 24 de Diciembre — Panama City, Panama (Recruiting)
• Cevaxin - Chorrera — Panama City, Panama (Recruiting)
• Cevaxin-- Avenida Mexico — Panama City, Panama (Recruiting)

Study contacts

• Principal investigator: Xavier Saez-Llorens, MD — Cevaxin
• Study coordinator: Xavier Saez-Llorens, MD

Conditions Poliomyelitis; Vaccine tolerability; Vaccine safety; Vaccine reactogenicity; Vaccine viral shedding; Vaccine immunogenicity