Co-administration of novel oral polio vaccines types 1 and 2 in infants

A Phase 2, Randomized, Double- Dummy, Observer-Blind Study to Evaluate the Safety and Immunogenicity of Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines in Healthy Young Infants Relative to Monovalent Vaccines Alone in Panama.

This study will test whether giving infants both new oral type 1 and type 2 polio vaccines together is safe and produces immune responses similar to giving each vaccine alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 675 (estimated)
• Ages: 6 Weeks to 7 Weeks
• Sex: All
• Sponsor: Path (Academic / other)
• Locations: 3 sites (Panama City and 2 other locations)
• Trial ID: NCT06895486 on ClinicalTrials.gov

What this trial studies

Healthy infants are randomized at 16 weeks into three groups to receive either nOPV1 alone, nOPV2 alone, or both nOPV1+nOPV2 together using a double-dummy, observer-blind design. Vaccinations occur at 16, 20, and 24 weeks, with blood drawn at baseline and after each dose to measure neutralizing antibody responses by WHO-standard assays. Stool samples are collected to monitor type-specific vaccine virus shedding, and solicited reactogenicity and adverse events are tracked around each vaccination. The study compares safety, tolerability, and whether two or three doses of the combined vaccines are non-inferior in immune response to the corresponding monovalent regimens.

Who should consider this trial

Good fit: Healthy infants around 16 weeks old who have received routine EPI vaccines including a single IPV dose at 6 weeks, have no prior OPV doses, and whose parents can provide consent and attend scheduled visits are ideal candidates.

Not a fit: Infants with significant medical conditions, prior OPV vaccination, or inability to complete follow-up visits are not appropriate and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, co-administered nOPV1 and nOPV2 could simplify infant immunization and protect against both polio types with comparable safety and immunity.

How similar studies have performed: nOPV2 vaccines have shown promising safety and immunogenicity in prior studies and outbreak use, but co-administration of nOPV1 and nOPV2 is a relatively new approach with limited prior data.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.
3. 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).
4. 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.
5. Prior to study vaccination has received no doses of OPV, based upon no evidence of such vaccination per available documentation.
6. Parent agrees for participant to receive routine infant and childhood immunizations as per the approved protocol-adjusted schedule.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Premature birth (less than 37 weeks gestation).
5. From multiple births (due to increased risk of OPV transmissions between siblings).
6. Moderate or severe (grade ≥ 2) acute illness at the time of eligibility/first study vaccination - temporary exclusion. Note: Participants with mild (grade 1) acute illnesses may be considered eligible at the discretion of the investigator.
7. Presence of fever on the day of randomization/first study vaccination (axillary temperature ≥37.5˚C) - temporary exclusion.
8. Presence of abnormal vital signs (respiratory rate and/or heart rate) for age on the day of randomization/first study vaccination - temporary exclusion.
9. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
10. Any reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member. Topical and inhaled steroids are permitted.
11. 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.
12. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
13. 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 sufficient weight to attain z-score ≥-3 SD.
14. Receipt of any investigational product prior to the first administration of study vaccine, or planned use during the study period.
15. Receipt of rotavirus vaccine within 2 weeks prior to first study vaccination.
16. Prior receipt of an investigational product containing poliovirus vaccine.
17. Receipt of transfusion of any blood product or immunoglobulins prior to the first administration of study vaccine or planned use during the study period.
18. 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).

Where this trial is running

Panama City and 2 other locations

• Cevaxin - 24 de Diciembre — Panama City, Panama (Recruiting)
• Cevaxin - Ave. México — Panama City, Panama (Recruiting)
• Cevaxin - Chorrera — Panama City, Panama (Recruiting)

Study contacts

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

Conditions Poliomyelitis; Vaccine; Polio; novel oral polio vaccine