PoliomyelitisPhase 4NCT05677256
A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2
A Phase 4 study testing nOPV2 in people with Poliomyelitis, run by Fidec Corporation at 1 site in Bangladesh.
Trial summary
The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants Read more about this study
- Who is it for?
- Ages 5 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- nOPV2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteBangladesh
- Study dates
- 9 Nov 2023to 25 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 6 to 8 weeks with birth weight >2,500 g.
- Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
- Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
Who cannot join
- Infants who have received previous vaccination against poliomyelitis.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)
Show all 10Show fewer
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
- Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
- Infants from multiple births or born prematurely (< 37 weeks of gestation).
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Diseases Research
Dhaka, 1212
About this study
Official title: A Phase IV Open-label, Randomized, Parallel-group Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2 in Healthy bOPV- Versus IPV-vaccinated Infants
The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants
Read the detailed description
In the light of the switch from OPV to IPV and the continued presence of cVDPV2 in many countries, it is important to understand and quantify the impact of IPV on pharyngeal mucosal immunity, to inform whether and to what extent the mucosal and humoral immune response following IPV could reduce transmission and spread.
This study will assess the effect of vaccination with IPV in parallel with poliovirus type-2 naïve infants (infants having received bOPV) on the pharyngeal and fecal shedding and the induction of immunity following type-2 poliovirus challenge. This understanding would provide critical information on the potential use of IPV in specific settings to interrupt transmission / reduce spread. The results from this study may potentially have important consequences on public health policy in countries which use IPV for infant priming, as they will help to show the extent to which a type-2 mucosal immunity gap remains following a primary series of IPV.
- Conditions
- Poliomyelitis
- Being tested
- nOPV2
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nOPV2Biological
Vaccination
| Study group | Role | What they receive |
|---|---|---|
| IPV-primed Group | Experimental | Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. Receives: Biological: nOPV2 |
| bOPV-primed Group | Active comparator | Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. Receives: Biological: nOPV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Shedding Detectable Levels of Poliovirus Type-2 by RT PCR.
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
Measured: 1 month
Secondary outcomes (4)
Pharyngeal Neutralizing Antibodies (NAbs) to Poliovirus Type-2.
To assess and compare the pharyngeal NAbs poliovirus type-2 activity on D0, D14 and D28 in both groups.
Measured: 1 month
Seroprotection Rate to Poliovirus Type-2 on D0, D28 and D56 in Both Groups.
To assess the humoral immunogenicity to poliovirus type-2 at D0, 4 and 8 weeks following administration of a challenge dose of nOPV2 in both groups.
Seroprotection is defined as neutralizing type-2 poliovirus antibody specific titers ≥1:8.
Measured: 2 months
Number of Participants That Experienced Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
To assess the number of subjects experiencing SAEs and IMEs following administration of IPV, bOPV and nOPV2 throughout the whole study period.
Measured: 5 months
Pharyngeal Poliovirus Type-2-specific Immunoglobulin A (IgA) Concentrations
To asses and compare the pharyngeal mucosal immunoglobulin class-specific immune response to poliovirus type-2 at Day 0, 2 and 4 weeks following administration of a challenge dose of nOPV2 in both groups.This is measured in geometric mean concentrations (GMCs) in nasal samples on D0, D14 and D28 in both groups.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start9 Nov 2023
- Primary completion20 Feb 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidec Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677256
- Sponsor's protocol ID
- IPV-005-ABMG
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2022
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zaman K, Bandyopadhyay AS, Gast C, Goswami DR, Hoque M, Raqib R, Hossain L, Haque W, Islam A, Rashid HO, Rahman M, Aguirre G, Brickley EB, Godin A, Weiner JA, Burke RM, Ackerman ME, Sifontes G, Mainou BA, Wright PF, Ruttimann R. Effect of inactivated poliovirus vaccine on nasal mucosal immunity and pharyngeal shedding following novel oral poliovirus vaccine type 2 challenge: A randomized, open-label trial. J Infect Dis. 2026 Aug 18:jiag423. doi: 10.1093/infdis/jiag423. Online ahead of print.
PubMed 42610930
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open-label, Randomized, Parallel-group Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2 in Healthy bOPV- Versus IPV-vaccinated Infants
- ClinicalTrials.gov ID
- NCT05677256
- Acronym / sponsor ID
- IPV-005-ABMG
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Fidec CorporationUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Posted 3 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants
Detailed description
In the light of the switch from OPV to IPV and the continued presence of cVDPV2 in many countries, it is important to understand and quantify the impact of IPV on pharyngeal mucosal immunity, to inform whether and to what extent the mucosal and humoral immune response following IPV could reduce transmission and spread.
This study will assess the effect of vaccination with IPV in parallel with poliovirus type-2 naïve infants (infants having received bOPV) on the pharyngeal and fecal shedding and the induction of immunity following type-2 poliovirus challenge. This understanding would provide critical information on the potential use of IPV in specific settings to interrupt transmission / reduce spread. The results from this study may potentially have important consequences on public health policy in countries which use IPV for infant priming, as they will help to show the extent to which a type-2 mucosal immunity gap remains following a primary series of IPV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPV-primed Group | Experimental | Biological: nOPV2Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. |
| bOPV-primed Group | Active comparator | Biological: nOPV2Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. |
Who may qualify
- Ages
- 5 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged 6 to 8 weeks with birth weight >2,500 g.
- Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
- Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
Key exclusion criteria (10 listed)
- Infants who have received previous vaccination against poliomyelitis.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.
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 |
|---|---|---|
| nOPV2Vaccination | Biological | IPV-primed Group, bOPV-primed Group |
Primary outcome
Number of Participants Shedding Detectable Levels of Poliovirus Type-2 by RT PCR.
Time frame: 1 month
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
4 secondary outcomes
Pharyngeal Neutralizing Antibodies (NAbs) to Poliovirus Type-2.
Time frame: 1 month
Seroprotection Rate to Poliovirus Type-2 on D0, D28 and D56 in Both Groups.
Time frame: 2 months
Number of Participants That Experienced Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
Time frame: 5 months
Pharyngeal Poliovirus Type-2-specific Immunoglobulin A (IgA) Concentrations
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42610930Zaman K, Bandyopadhyay AS, Gast C, Goswami DR, Hoque M, Raqib R, Hossain L, Haque W, Islam A, Rashid HO, Rahman M, Aguirre G, Brickley EB, Godin A, Weiner JA, Burke RM, Ackerman ME, Sifontes G, Mainou BA, Wright PF, Ruttimann R. Effect of inactivated poliovirus vaccine on nasal mucosal immunity and pharyngeal shedding following novel oral poliovirus vaccine type 2 challenge: A randomized, open-label trial. J Infect Dis. 2026 Aug 18:jiag423. doi: 10.1093/infdis/jiag423. Online ahead of print.
- Individual participant dataSharing planned: No
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Poliomyelitis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nOPV2 in people with Poliomyelitis, run by Fidec Corporation at 1 site in Bangladesh.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Shedding Detectable Levels of Poliovirus Type-2 by RT PCR. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677256, which also lists 1 linked publication.
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 3 Sep 2026.