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RecruitingNCT05654467Updated May 11, 2026

Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama

A Phase 2 interventional study of Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3) and Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3) in Poliomyelitis, sponsored by PATH. Recruiting at 3 sites in Panama. Open to participants aged 1 Day to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by PATH · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
1,532
Allocation
Randomized
Ages
1 Day to 4 Years
Sex
All
01

Study summary

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).

Read the detailed description

This multicentered, 12-arm phase 2 study will be the first pediatric evaluation of nOPV3 in healthy young children, infants, and newborns. This trial will be initiated once results in the adult phase 1 study of nOPV3 indicate that there are no safety concerns, and that the vaccine elicits demonstrable immunogenicity. Additionally, prior to enrolling into cohort 2, the adult phase 1 data must show no concerning signals of reversion of attenuating sites from a subset of Next Generation Sequencing.

This study is intended to provide critical data on safety, immunogenicity, and genetic stability, as well as to demonstrate the vaccine's ability to reduce fecal shedding following a challenge with the Sabin type 3 strain.

Enrollment in this pediatric study will be staggered into three age-descending cohorts of 6 treatment groups of escalated target dose levels for the nOPV3 vaccine: cohort 1 composed of 192 healthy young children 1 to \<5 years of age who have completed their full routine polio immunization series; cohort 2 composed of 860 healthy infants 6 weeks of age not previously vaccinated (OPV/IPV) who will be primed with a dose of inactivated poliomyelitis vaccine (IPV) prior to OPV3 vaccination [a subset, of the infants (n=360) will also receive the challenge virus]; and cohort 3, composed of 480 healthy poliomyelitis unvaccinated neonates (day of birth +3 days).

Progression into the next cohort and groups within cohorts will depend on safety evaluations of the prior Phase 1 adult trial and Day 8 safety evaluation of the previous groups in prior cohorts in the study.

02

Conditions studied

  • Poliomyelitis

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Keywords

  • Vaccine tolerability
  • Vaccine safety
  • Vaccine reactogenicity
  • Vaccine viral shedding
  • Vaccine immunogenicity
03

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's planned enrollment of 1,532 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Browse PATH studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 4 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria

Inclusion Criteria for all participants:

  1. Healthy, as defined by the absence of any 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 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, , 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 or immunodeficiency condition (including 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 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).
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,532 participants (estimated)

Study arms

  • Experimental
    Group 1: Young Children, nOPV3 10^5.5 CCID50

    48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 1 and Day 29

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)

  • Experimental
    Group 3: Young Children, nOPV3 10^6.0 CCID50

    48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 1 and Day 29

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)

  • Experimental
    Group 5: Young Children, nOPV3 10^6.5 CCID50

    48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 1 and Day 29

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)

  • Active comparator
    Groups 2, 4 and 6: Young Children, mOPV3

    48 young children aged 1 to \<5 years will receive 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 1 and Day 29

    Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)

  • Experimental
    Group 7: Infants, nOPV3 10^5.5 CCID50

    240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)

  • Experimental
    Group 9: Infants, nOPV3 10^5.5 CCID50

    240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)

  • Experimental
    Group 11: Infants, nOPV3 10^6.5 CCID50

    140 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)

  • Active comparator
    Groups 8, 10 and 12: Infants, mOPV3

    240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.

    Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)

  • Experimental
    Group 13: Neonates, nOPV3 10^5.5 CCID50

    120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 1 and Day 29.

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)

  • Experimental
    Group 15: Neonates, nOPV3 10^6.0 CCID50

    120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 1 and Day 29.

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)

  • Experimental
    Group 17: Neonates, nOPV3 10^6.5 CCID50

    120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 1 and Day 29.

    Biological: Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)

  • Active comparator
    Groups 14, 16 and 18: Neonates, mOPV

    120 neonates (day of birth + 3 days) will receive 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 1 and Day 29

    Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)

Interventions

  • BiologicalNovel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)

    The nOPV3 vaccine containing approximately 10\^5.5, 10\^6.0, or 10\^6.5 CCID50 per dose.

  • BiologicalSabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)

    The Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 control and challenge vaccine (mOPV3) containing ≥ 10\^5.8 CCID50 per dose.

06

What researchers measure

Primary outcomes

  1. Frequency of serious adverse events (SAEs)

    Serious adverse event is any adverse event that results in any of the following outcomes: 1. Death 2. Is life-threatening (life-threatening means that the study participant was, in the opinion of the site PIs or PATH, at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital abnormality or birth defect. 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.

    Time frame: Up to last visit for last subject, around 18 months

  2. Frequency of solicited adverse events (AEs) for 7 days (day of vaccination and 6 following days) after each vaccination

    Solicited AEs are pre-specific AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. The following specific solicited AEs will be monitored for this trial: Fever (axillary temperature ≥ 37.5°C) Vomiting Diarrhea Irritability Decreased feeding or appetite Fatigue or decreased activity

    Time frame: Vaccination to 7 days post vaccination

  3. Frequency of unsolicited AEs for 28 days (day of vaccination and 27 following days) after each vaccination

    Unsolicited AEs are any AEs reported spontaneously by the participant's parent, observed by the study personnel during study visits or identified during review of medical records or source documents. In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant will be reported as an AE.

    Time frame: From vaccination to 28 days post vaccination

  4. Post-vaccination frequency of seroconversion of type 3 anti-polio serum neutralizing antibody (NAb) in infants.

    For previously vaccinated cohorts, seroconversion will be defined as a minimum 4-fold rise in titer relative to the baseline value among those initially seropositive.

    Time frame: 28 days post second vaccination

Secondary outcomes

  1. Post-vaccination frequency of seroconversion of type 3 anti-polio serum NAb

    For previously vaccinated cohorts, seroconversion will be defined as a minimum 4-fold rise in titer relative to the baseline value among those initially seropositive and for unvaccinated neonates, seroconversion will be defined as a minimum 4-fold higher antibody titer relative to the expected level of maternal antibody.

    Time frame: Baseline and 28 days post vaccination (Day 1 and Day 29 for neonates; Day 29,Day 57 and Day 85 for infants; Day 1, Day 29 and Day 57 young children)

  2. Median type 3 anti-polio serum NAb titers

    Elicited by nOPV3, compared to that of mOPV3, following one or two doses in healthy young children, infants, and neonates.

    Time frame: Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)

  3. Type 3 anti-polio serum NAb Geometric Mean Titer (GMT)

    Elicited by nOPV3, compared to that of mOPV3, following one or two doses in healthy young children, infants, and neonates.

    Time frame: Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates;Day 29, Day 57 and Day 85 for infants)

  4. Post-vaccination GMT ratios of type 3 anti-polio serum NAb, adjusted for baseline immunity

    Elicited by nOPV3, compared to that of mOPV3, following one or two doses in healthy young children, infants, and neonates.

    Time frame: Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)

  5. Seroprotection rate, defined as type 3 anti-polio serum NAb reciprocal titer ≥ 8

    Elicited by nOPV3, compared to that of mOPV3, following one or two doses in healthy young children, infants, and neonates.

    Time frame: Baseline and 28 days post vaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day 57 and Day 85 for infants)

  6. Geometric mean fold rise (GMFR) in NAb titer relative to baseline for post-dose-1 and relative to post-dose-1 for post-dose-2.

    Elicited by nOPV3, compared to that of mOPV3, in healthy young children, infants,and neonates.

    Time frame: Baseline and 28 days postvaccination (Day 1, Day 29 and Day 57 for young children and neonates; Day 29, Day57 and Day 85 for infants)

  7. Proportion of participants shedding type 3 poliovirus at any and at each post-vaccination stool collection, as assessed by polymerase chain reaction (PCR) in infants

    After the initial dose of nOPV3, compared to mOPV3

    Time frame: Baseline through to 28 days post initial vaccination (Day 29 through to Day 57 for infants)

  8. Proportion of participants shedding type 3 poliovirus at any and at each post-challenge stool collection, as assessed by PCR in infants

    In participants negative for type 3 poliovirus in their last pre-challenge stool sample

    Time frame: Day of challenge through to 28 days post challenge (Day 113 through to Day 141, for infants)

  9. Neurovirulence of shed study vaccine virus from select stool samples as measured by a transgenic mouse neurovirulence test in a subset of infants

    Within 28 days of an initial nOPV dose and compared to that of mOPV3

    Time frame: Baseline through to 28 days post initial vaccination (Day 1 through to Day 29 for neonates)

07

Study locations

3 of 3 sites recruiting
  • Cevaxin - 24 de Diciembre
    Panama City, Panama
    Recruiting
    • Xavier Saez-Llorens, MD · Contactxavier.saez-llorens@cevaxin.com · +507 203-9760
    • Jovanna Miranda, MD · Sub investigator
    • Erick Mastrolinardo, MD · Sub investigator
    • Xavier Saez-Llorens, MD · Principal investigator
  • Cevaxin - Chorrera
    Panama City, Panama
    Recruiting
    • Xavier Saez-Llorens · Contactxavier.saez-llorens@cevaxin.com · +507 2039760
    • Dommie Arias, MD · Principal investigator
    • Nancy Zamora, MD · Sub investigator
    • Luis Márquez, MD · Sub investigator
  • Cevaxin-- Avenida Mexico
    Panama City, Panama
    Recruiting
    • Xavier Saez-Llorens, MD · Contactxavier.saez-llorens@cevaxin.com · +507 203-9760
    • Grace Espino, MD · Sub investigator
    • Horacio Arauz, MD · Sub investigator
    • Dora Estripeaut, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05654467
Lead sponsor
PATH
Collaborators
Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, Technical Resources International, Inc.
Responsible party
Sponsor
First posted
Dec 16, 2022
Start date
Dec 5, 2023
Primary completion
Mar 20, 2027 (estimated)
Completion
Mar 20, 2027 (estimated)
Last update
May 11, 2026

Study contacts

Xavier Saez-Llorens, MD
Contact
xavier.saez-llorens@cevaxin.com
+507 203-9760
Xavier Saez-Llorens, MD
principal investigator · Cevaxin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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