Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation

NCT06895486 | Recruiting Phase 2 DMC

• 3 other identifiers: CVIA 109U1111-1320-8206RES-00751
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.

Conditions

Poliomyelitis

Keywords

Vaccine; Polio; Poliomyelitis; novel oral polio vaccine

Outcome Measures

Primary Outcomes (5)

• Frequency of serious adverse events (SAEs)

  Serious adverse event is any adverse event that results in any of the following outcomes: 1) Death, 2) Life-threatening, 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, or 5) Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or (and) require medical or surgical intervention to prevent one of the outcomes listed in the above

  From time of Dose 1 to end of study at Day 113

• Frequency of solicited adverse events (AEs)

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

  From time of vaccination until 7 days after Dose 1 (Day 8), Dose 2 (Day 36), and Dose 3 (Day 57)

• Frequency of unsolicited AEs

  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.

  From time of vaccination to 28 days after Dose 1 (Day 29), Dose 2 (Day 57), and Dose 3 (Day 85)

• Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum neutralizing antibody (NAb)

  Cumulative Seroconversion is defined as type specific minimum 4-fold rise from baseline in those seropositive (NAb titer ≥1:8) at baseline, or post-vaccination seropositivity (titer ≥1:8) among those seronegative at baseline

  28 days after Dose 2 (Day 57)

• Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum NAb

  Cumulative Seroconversion is defined as type specific minimum 4-fold rise from baseline in those seropositive (NAb titer ≥1:8) at baseline, or post-vaccination seropositivity (titer ≥1:8) among those seronegative at baseline

  28 days after Dose 3 (Day 85)

Secondary Outcomes (8)

• Percentage of participants demonstrating cumulative seroconversion of type 1 and 2 anti-polio serum NAb

  28 days after Dose 1

• Median titer for type 1 and 2 anti-polio serum NAb

  28 days after Dose 1, Dose 2, and Dose 3

• Geometric mean titer (GMT) for Types 1 and 2 anti-polio serum NAb

  28 days after Dose 1, Dose 2, and Dose 3

• Post-vaccination GMT ratios of types 1 and 2 anti-polio serum NAb

  Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3

• Type-specific and multitypic seroprotection*** rate.

  28 days after Dose 1, Dose 2, and Dose 3

Study Arms (3)

Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placebo

EXPERIMENTAL

nOPV1 and oral placebo (sterile water) given to 225 healthy infants

Biological: Novel Oral Polio Vaccine Type 1 (nOPV1); Biological: Placebo (Sterile Water)

Group 2: Novel Oral Polio Vaccine Type 2 (nOPV2) and placebo

EXPERIMENTAL

nOPV2 and oral placebo (sterile water) given to 225 healthy infants

Biological: Novel Oral Polio Vaccine Type 2 (nOPV2); Biological: Placebo (Sterile Water)

Group 3: nOPV1 and nOPV2

EXPERIMENTAL

nOPV1 given along with nOPV2 to 225 healthy infants

Biological: Novel Oral Polio Vaccine Type 1 (nOPV1); Biological: Novel Oral Polio Vaccine Type 2 (nOPV2)

Interventions

Novel Oral Polio Vaccine Type 2 (nOPV2) BIOLOGICAL

nOPV2 containing ≥10\^5.0 CCID50 per dose

Group 2: Novel Oral Polio Vaccine Type 2 (nOPV2) and placebo; Group 3: nOPV1 and nOPV2

Placebo (Sterile Water) BIOLOGICAL

Sterile, nonpyrogenic preparation of water which contains no bacteriostat, antimicrobial agent, or added buffer

Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placebo; Group 2: Novel Oral Polio Vaccine Type 2 (nOPV2) and placebo

Novel Oral Polio Vaccine Type 1 (nOPV1) BIOLOGICAL

nOPV1 containing \>10\^7.0 CCID50 per dose

Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placebo; Group 3: nOPV1 and nOPV2

Eligibility Criteria

• Age: 6 Weeks - 7 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female infant 16 weeks (+ 7 days) of age, at the time of first study vaccination. 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 by the investigator.
• Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.
• Resides in study area and parent 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).
• Prior to study vaccination has received EPI vaccines as per the study EPI schedule and has received a single dose of IPV at 6 weeks (+7 days) of age.
• Prior to study vaccination has received no doses of OPV, based upon no evidence of such vaccination per available documentation.
• Parent agrees for participant to receive routine infant and childhood immunizations as per the approved protocol-adjusted schedule.

You may not qualify if:

• 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 (as per local guidelines) with respect to poliovirus vaccines at the time of study vaccine administration.
• 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 3 months before study vaccine administration. Participants from household where a member received investigational nOPV3 vaccine will also be excluded from the study.
• Low birth weight (LBW), defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth.
• Premature birth (less than 37 weeks gestation).
• From multiple births (due to increased risk of OPV transmissions between siblings).
• 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 reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member. Topical and inhaled steroids are permitted.
• Receipt of any 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. Topical and inhaled steroids are permitted.
• Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
• Receipt of any investigational product prior to the first administration of study vaccine, or planned use during the study period.
• Receipt of rotavirus vaccine within 2 weeks prior to first study vaccination.
• Prior receipt of an investigational product containing poliovirus vaccine.
• Receipt of transfusion of any blood product or immunoglobulins prior to the first administration of study vaccine or planned use during the study period.
• Parent 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).

Sponsors & Collaborators

• PATH: lead
• Bill and Melinda Gates Foundation: collaborator
• PT Bio Farma: collaborator
• Technical Resources International, Inc. (TRI): collaborator
• Centro de Vacunación e Investigación (Cevaxin): collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

Cevaxin - 24 de Diciembre

Panama City, Panama

RECRUITING

Cevaxin - Ave. México

Panama City, Panama

RECRUITING

Cevaxin - Chorrera

Panama City, Panama

RECRUITING

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Xavier Saez Llorens, MD

  Cevaxin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Saez-Llorens

CONTACT

+507-398-4386; xavier.saez-llorens@cevaxin.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)