PoliomyelitisPhase 2SCOPENCT06895486
Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation
A Phase 2 study testing Novel Oral Polio Vaccine Type 1 (nOPV1) and Novel Oral Polio Vaccine Type 2 (nOPV2) in people with Poliomyelitis, run by PATH at 3 sites in Panama.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 7 weeksHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Novel Oral Polio Vaccine Type 1 (nOPV1) and Novel Oral Polio Vaccine Type 2 (nOPV2)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 675 participants
- Where
- 3 sitesPanama
- Study dates
- 11 Nov 2025to 28 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 7 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
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- Presence of fever on the day of randomization/first study vaccination (axillary temperature ≥37.5˚C) - temporary exclusion.
- Presence of abnormal vital signs (respiratory rate and/or heart rate) for age on the day of randomization/first study vaccination - temporary exclusion.
- 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.
- 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.
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Panama3 sites, 3 recruiting
- Recruiting
Cevaxin - 24 de Diciembre
Panama City
Xavier Saez Llorens
- Recruiting
Cevaxin - Ave. México
Panama City
Dora Estripeaut, MD
- Recruiting
Cevaxin - Chorrera
Panama City
Dommie Arias, MD
About this study
Official title: 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.
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.
Read the detailed description
This is a randomized, double dummy, observer blind, active comparator-controlled study. The study population will comprise healthy infants randomized at 16 weeks of age equally across three study groups, nOPV1 only group (N=225), nOPV2 only group (N=225) and co-administered nOPV1+ nOPV2 group (N=225). The participants in the nOPV1 and nOPV2 groups will receive concomitant oral placebo (sterile water) to blind the study arms for parents.
Participants will be screened (screening period 10 weeks), randomized and administered the first dose of study vaccine(s) at 16 weeks of age. The second and third dose of study vaccine(s) will be administered at 20 and 24 weeks of age, respectively. Participants will be consented and screened at 6 weeks of age and receive their routine Expanded Program on Immunization (EPI) vaccines by the study team. For each group, blood will be collected for immunologic testing at 16 (baseline), 20, 24, and 28 weeks of age. Serum specimens will be tested for humoral responses to vaccination by measurement of serum neutralizing antibody (NAb) according to established World Health Organization (WHO) protocols. Stool samples will be collected at various timepoints to evaluate type-specific shedding of polio virus following vaccination.
Following vaccination, participants will be monitored for at least 30 minutes for any immediate adverse events (AEs). Reactogenicity (solicited AEs) will be assessed during the 7 days (day of vaccination and 6 following days) after each vaccination. Parents will be given a post-immunization memory aid to record any local and systemic solicited reactions. In addition, data for unsolicited AEs will be collected for 28 days (day of study vaccination and 27 following days) after each vaccination. Data for SAEs will be collected throughout the study period following vaccination.
- Conditions
- Poliomyelitis
- Being tested
- Novel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 2 (nOPV2), Placebo (Sterile Water)
- Keywords
- Vaccine, Polio, Poliomyelitis, novel oral polio vaccine
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Oral Polio Vaccine Type 1 (nOPV1)Biological
nOPV1 containing >10^7.0 CCID50 per dose
Novel Oral Polio Vaccine Type 2 (nOPV2)Biological
nOPV2 containing ≥10^5.0 CCID50 per dose
Placebo (Sterile Water)Biological
Sterile, nonpyrogenic preparation of water which contains no bacteriostat, antimicrobial agent, or added buffer
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placebo | Experimental | nOPV1 and oral placebo (sterile water) given to 225 healthy infants Receives: 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 Receives: 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 Receives: Biological: Novel Oral Polio Vaccine Type 1 (nOPV1); Biological: Novel Oral Polio Vaccine Type 2 (nOPV2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 28 days after Dose 1
Median titer for type 1 and 2 anti-polio serum NAb
Measured: 28 days after Dose 1, Dose 2, and Dose 3
Geometric mean titer (GMT) for Types 1 and 2 anti-polio serum NAb
Measured: 28 days after Dose 1, Dose 2, and Dose 3
Post-vaccination GMT ratios of types 1 and 2 anti-polio serum NAb
Measured: Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3
Type-specific and multitypic seroprotection*** rate.
Seroprotection rate defined as anti-polio serum NAb reciprocal titer ≥ 8.
Measured: 28 days after Dose 1, Dose 2, and Dose 3
Geometric mean fold rise (GMFR) in NAb titer relative to baseline
For immunogenicity evaluation, baseline is defined as NAb measurement prior to the first nOPV dose at 16 weeks of age
Measured: Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3
GMFR in NAb titer following each dose relative to the pre-vaccination value.
For immunogenicity evaluation, baseline is defined as NAb measurement prior to the first nOPV dose at 16 weeks of age
Measured: Pre-vaccination titer compared to 28 days after Dose 1, Dose 2, and Dose 3
Percentage of participants shedding types 1 and/or 2 polioviruses
Assessed by polymerase chain reaction (PCR)
Measured: At Day 1, Day 8, Day 29, Day 36, Day57, Day 64, Day 85 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start11 Nov 2025
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, Technical Resources International, Inc., Centro de Vacunación e Investigación (Cevaxin)
- Responsible party
- Sponsor
- Investigators
- Xavier Saez Llorens, MD, Principal investigator, Cevaxin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895486
- Sponsor's protocol ID
- CVIA 109
- Other IDs
- U1111-1320-8206, RES-00751
- Acronym
- SCOPE
- Status last verified
- Jan 2026
- First submitted
- 19 Mar 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06895486
- Acronym / sponsor ID
- SCOPE / CVIA 109
- Conditions
- Poliomyelitis
- Keywords
- Vaccine, Polio, Poliomyelitis, novel oral polio vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, Technical Resources International, Inc., Centro de Vacunación e Investigación (Cevaxin)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double dummy, observer blind, active comparator-controlled study. The study population will comprise healthy infants randomized at 16 weeks of age equally across three study groups, nOPV1 only group (N=225), nOPV2 only group (N=225) and co-administered nOPV1+ nOPV2 group (N=225). The participants in the nOPV1 and nOPV2 groups will receive concomitant oral placebo (sterile water) to blind the study arms for parents.
Participants will be screened (screening period 10 weeks), randomized and administered the first dose of study vaccine(s) at 16 weeks of age. The second and third dose of study vaccine(s) will be administered at 20 and 24 weeks of age, respectively. Participants will be consented and screened at 6 weeks of age and receive their routine Expanded Program on Immunization (EPI) vaccines by the study team. For each group, blood will be collected for immunologic testing at 16 (baseline), 20, 24, and 28 weeks of age. Serum specimens will be tested for humoral responses to vaccination by measurement of serum neutralizing antibody (NAb) according to established World Health Organization (WHO) protocols. Stool samples will be collected at various timepoints to evaluate type-specific shedding of polio virus following vaccination.
Following vaccination, participants will be monitored for at least 30 minutes for any immediate adverse events (AEs). Reactogenicity (solicited AEs) will be assessed during the 7 days (day of vaccination and 6 following days) after each vaccination. Parents will be given a post-immunization memory aid to record any local and systemic solicited reactions. In addition, data for unsolicited AEs will be collected for 28 days (day of study vaccination and 27 following days) after each vaccination. Data for SAEs will be collected throughout the study period following vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placebo | Experimental | Biological: Novel Oral Polio Vaccine Type 1 (nOPV1), Biological: Placebo (Sterile Water)nOPV1 and oral placebo (sterile water) given to 225 healthy infants |
| Group 2: Novel Oral Polio Vaccine Type 2 (nOPV2) and placebo | Experimental | Biological: Novel Oral Polio Vaccine Type 2 (nOPV2), Biological: Placebo (Sterile Water)nOPV2 and oral placebo (sterile water) given to 225 healthy infants |
| Group 3: nOPV1 and nOPV2 | Experimental | Biological: Novel Oral Polio Vaccine Type 1 (nOPV1), Biological: Novel Oral Polio Vaccine Type 2 (nOPV2)nOPV1 given along with nOPV2 to 225 healthy infants |
Who may qualify
- Ages
- 6 to 7 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Oral Polio Vaccine Type 1 (nOPV1)nOPV1 containing >10^7.0 CCID50 per dose | Biological | Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placebo, Group 3: nOPV1 and nOPV2 |
| Novel Oral Polio Vaccine Type 2 (nOPV2)nOPV2 containing ≥10^5.0 CCID50 per dose | Biological | Group 2: Novel Oral Polio Vaccine Type 2 (nOPV2) and placebo, Group 3: nOPV1 and nOPV2 |
| Placebo (Sterile Water)Sterile, nonpyrogenic preparation of water which contains no bacteriostat, antimicrobial agent, or added buffer | Biological | Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placebo, Group 2: Novel Oral Polio Vaccine Type 2 (nOPV2) and placebo |
Primary outcome
Frequency of serious adverse events (SAEs)
Time frame: From time of Dose 1 to end of study at Day 113
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
Frequency of solicited adverse events (AEs)
Time frame: From time of vaccination until 7 days after Dose 1 (Day 8), Dose 2 (Day 36), and Dose 3 (Day 57)
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
Frequency of unsolicited AEs
Time frame: From time of vaccination to 28 days after Dose 1 (Day 29), Dose 2 (Day 57), and Dose 3 (Day 85)
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.
Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum neutralizing antibody (NAb)
Time frame: 28 days after Dose 2 (Day 57)
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
Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum NAb
Time frame: 28 days after Dose 3 (Day 85)
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
8 secondary outcomes
Percentage of participants demonstrating cumulative seroconversion of type 1 and 2 anti-polio serum NAb
Time frame: 28 days after Dose 1
Median titer for type 1 and 2 anti-polio serum NAb
Time frame: 28 days after Dose 1, Dose 2, and Dose 3
Geometric mean titer (GMT) for Types 1 and 2 anti-polio serum NAb
Time frame: 28 days after Dose 1, Dose 2, and Dose 3
Post-vaccination GMT ratios of types 1 and 2 anti-polio serum NAb
Time frame: Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3
Type-specific and multitypic seroprotection*** rate.
Time frame: 28 days after Dose 1, Dose 2, and Dose 3
Geometric mean fold rise (GMFR) in NAb titer relative to baseline
Time frame: Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3
GMFR in NAb titer following each dose relative to the pre-vaccination value.
Time frame: Pre-vaccination titer compared to 28 days after Dose 1, Dose 2, and Dose 3
Percentage of participants shedding types 1 and/or 2 polioviruses
Time frame: At Day 1, Day 8, Day 29, Day 36, Day57, Day 64, Day 85 of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xavier Saez Llorens, MD principal investigator
Cevaxin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Novel Oral Polio Vaccine Type 1 (nOPV1) and Novel Oral Polio Vaccine Type 2 (nOPV2) in people with Poliomyelitis, run by PATH at 3 sites in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Saez-Llorens (+507-398-4386, xavier.saez-llorens@cevaxin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of serious adverse events (SAEs) (time frame: From time of Dose 1 to end of study at Day 113). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.