PolioPhase 4NCT06114810
Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV
A Phase 4 study testing polio vaccines: nOPV2, bOPV, IPV in people with Polio, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
Trial summary
The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV: 1. Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps; 2. Separation of bOPV and nOPV2 with an interval of 4 weeks. Read more about this study
- Who is it for?
- Ages 42 to 48 daysHealthy volunteers can take part
- Conditions the study is for
- Polio
- What is being tested?
- polio vaccines: nOPV2, bOPV, IPV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 42 to 48 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 6 weeks of age
- Parents that consent for participation in the full length of the study.
- Parents that can understand and comply with planned study procedures.
Who cannot join
- Parents and infants are unable to participate in the full length of the study
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder
- Acute diarrhoea, infection, or illness at the time of enrolment
- Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit
- Evidence of a chronic medical condition
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- Receipt of any polio vaccine (OPV or IPV) before enrolment
- Known allergy/sensitivity or reaction to polio vaccine, or its contents.
- Infants from multiple births.
- Infants from premature births (<37 weeks of gestation).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), Bivalent Oral Poliovirus Vaccine (bOPV) and Inactivated Poliovirus Vaccine (IPV) Administered With Different Sequential or Combination Schedules
The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:
- Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps;
- Separation of bOPV and nOPV2 with an interval of 4 weeks.
Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.
Read the detailed description
The study will assess whether adding IPV at the end of a 3-dose series of co-administered nOPV2+bOPV achieves at least a 95% seroconversion to all serotypes and whether adding IPV following two doses of co-administered nOPV2+bOPV achieves at least a 90% seroconversion to all poliovirus types.
Study findings will inform vaccination strategies in areas with co-circulation of poliovirus types and provide information about immunogenicity of potential routine immunization schedule with nOPV2 and bOPV in countries with persistent transmission or emergences of cVDPV2.
This is an open-label, controlled, inequality, four arm randomized clinical trial, will be conducted in two study sites in Dhaka, Bangladesh. Participants will be enrolled at 6 weeks of age following inclusion and exclusion criteria's, randomly assigned to one of the four study arms and followed to 18 weeks of age. Three polio vaccines will be used in the study: bOPV, nOPV2 and IPV in different sequential or combination schedules.
Entry evaluations will be completed at 6 weeks of age. Blood collection and study vaccine administration are planned during the study entry evaluation. Post-entry evaluations and follow-up will be done at 10 weeks, 14 weeks and 18 weeks of age. Blood will be collected before any study or EPI vaccines are administered. Presence of poliovirus neutralizing antibodies to all three poliovirus types will be assessed using a microneutralization assay.
- Conditions
- Polio
- Being tested
- polio vaccines: nOPV2, bOPV, IPV
- Keywords
- nOPV2 bOPV IPV immunogenicity
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polio vaccines: nOPV2, bOPV, IPVBiological
Co-administration of nOPV2 with bOPV along with IPV with different sequential or combination schedules.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : 3 doses of nOPV2 and bOPV with IPV | Active comparator | Participants in arm A will receive the following polio vaccines: nOPV2 +bOPV (2 drops = 0.1 ml) @ 6, 10, 14 weeks and IPV (0.5 mL) @ 14 weeks Receives: Biological: polio vaccines: nOPV2, bOPV, IPV |
| Arm B : 2 doses of nOPV2 and bOPV with IPV | Active comparator | Participants in arm B will receive the following polio vaccines: nOPV2+bOPV , (2 drops = 0.1 ml) @ 6, 10 weeks and IPV (0.5 mL) @ 14 weeks Receives: Biological: polio vaccines: nOPV2, bOPV, IPV |
| Arm C: Single dose of bOPV, nOPV2, IPV | Active comparator | Participants in arm C will receive the following polio vaccines: bOPV ( 2 drops) @ 6 week , nOPV2 (2 drops) at 10 weeks and IPV ( 0.5mL) @ 14 weeks Receives: Biological: polio vaccines: nOPV2, bOPV, IPV |
| Arm D: Single dose nOPV2, IPV | Active comparator | Participants in arm D will receive the following polio vaccines: nOPV2 (2 drops = 0.1 ml) at 6 and 10 weeks and IPV ( 0.5mL) @ 14 weeks Receives: Biological: polio vaccines: nOPV2, bOPV, IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative seroconversion to all serotypes at the end of a vaccination series including two or three doses of co-administered nOPV2 and bOPV plus one dose of IPV.
Poliovirus antibody titers to types 1, 2 and 3 will be measured in sera extracted from blood collected at 6, 10, 14, and 18 weeks of age
Measured: Serology: 6 &18 weeks
Secondary outcomes (4)
Seroconversion for type 2 after one dose of nOPV2 alone, co-administered with bOPV, or administered 4-weeks after bOPV;
Compare type 2 seroconversion after one dose of nOPV2 administered alone or 4 weeks after bOPV
Measured: Serology: 6 & 14 weeks for C, 6 & 10 weeks for D,
Cumulative seroconversion for type 2 after two doses of nOPV2 administered alone or co-administered with bOPV;
Compare seroconversion to all three serotypes after one dose of nOPV2 administered 4 weeks after bOPV or concomitantly with bOPV
Measured: Serology: 6 & 14 weeks for C, 6 & 10 weeks for A
Cumulative seroconversion to all serotypes after 1 dose each of bOPV, nOPV2 and IPV administered sequentially one month apart.
Determine seroconversion to all serotypes reached with one dose of nOPV2, bOPV and IPV each administered sequentially at 4-week intervals (6, 10 and 14 weeks).
Measured: Serology: 6 & 18 weeks
Antibody titers for all 3 serotypes reached at the end of each vaccination schedule
Determine seroconversion to all serotypes
Measured: Serology: 6 & 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolioStudies 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
- Sequential
- Model description
- This is an open-label, controlled, inequality, 4 arm randomized clinical trial assessing immunogenicity of several poliovirus vaccines and doses
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Government of Bangladesh
- Responsible party
- Sponsor
- Investigators
- Dr. K Zaman, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114810
- Sponsor's protocol ID
- PR-23036
- Status last verified
- Sep 2023
- First submitted
- 12 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be jointly owned by icddr,b and CDC. After completion of study activities, summary tables of study results will be available on www.clinicaltrials.gov. After study registration, clinicaltrials.gov provides unrestricted public access on study details including summary tables. Study investigators will have access to all participants' data without identifiers, including laboratory data. Co-investigators and technical advisors will have access to relevant data as defined in protocol
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), Bivalent Oral Poliovirus Vaccine (bOPV) and Inactivated Poliovirus Vaccine (IPV) Administered With Different Sequential or Combination Schedules
- ClinicalTrials.gov ID
- NCT06114810
- Acronym / sponsor ID
- PR-23036
- Conditions
- Polio
- Keywords
- nOPV2 bOPV IPV immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Government of Bangladesh
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 Nov 2023 (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 goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:
- Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps;
- Separation of bOPV and nOPV2 with an interval of 4 weeks.
Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.
Detailed description
The study will assess whether adding IPV at the end of a 3-dose series of co-administered nOPV2+bOPV achieves at least a 95% seroconversion to all serotypes and whether adding IPV following two doses of co-administered nOPV2+bOPV achieves at least a 90% seroconversion to all poliovirus types.
Study findings will inform vaccination strategies in areas with co-circulation of poliovirus types and provide information about immunogenicity of potential routine immunization schedule with nOPV2 and bOPV in countries with persistent transmission or emergences of cVDPV2.
This is an open-label, controlled, inequality, four arm randomized clinical trial, will be conducted in two study sites in Dhaka, Bangladesh. Participants will be enrolled at 6 weeks of age following inclusion and exclusion criteria's, randomly assigned to one of the four study arms and followed to 18 weeks of age. Three polio vaccines will be used in the study: bOPV, nOPV2 and IPV in different sequential or combination schedules.
Entry evaluations will be completed at 6 weeks of age. Blood collection and study vaccine administration are planned during the study entry evaluation. Post-entry evaluations and follow-up will be done at 10 weeks, 14 weeks and 18 weeks of age. Blood will be collected before any study or EPI vaccines are administered. Presence of poliovirus neutralizing antibodies to all three poliovirus types will be assessed using a microneutralization assay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is an open-label, controlled, inequality, 4 arm randomized clinical trial assessing immunogenicity of several poliovirus vaccines and doses
| Arm | Type | Receives |
|---|---|---|
| Arm A : 3 doses of nOPV2 and bOPV with IPV | Active comparator | Biological: polio vaccines: nOPV2, bOPV, IPVParticipants in arm A will receive the following polio vaccines: nOPV2 +bOPV (2 drops = 0.1 ml) @ 6, 10, 14 weeks and IPV (0.5 mL) @ 14 weeks |
| Arm B : 2 doses of nOPV2 and bOPV with IPV | Active comparator | Biological: polio vaccines: nOPV2, bOPV, IPVParticipants in arm B will receive the following polio vaccines: nOPV2+bOPV , (2 drops = 0.1 ml) @ 6, 10 weeks and IPV (0.5 mL) @ 14 weeks |
| Arm C: Single dose of bOPV, nOPV2, IPV | Active comparator | Biological: polio vaccines: nOPV2, bOPV, IPVParticipants in arm C will receive the following polio vaccines: bOPV ( 2 drops) @ 6 week , nOPV2 (2 drops) at 10 weeks and IPV ( 0.5mL) @ 14 weeks |
| Arm D: Single dose nOPV2, IPV | Active comparator | Biological: polio vaccines: nOPV2, bOPV, IPVParticipants in arm D will receive the following polio vaccines: nOPV2 (2 drops = 0.1 ml) at 6 and 10 weeks and IPV ( 0.5mL) @ 14 weeks |
Who may qualify
- Ages
- 42 to 48 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants 6 weeks of age
- Parents that consent for participation in the full length of the study.
- Parents that can understand and comply with planned study procedures.
Key exclusion criteria (10 listed)
- Parents and infants are unable to participate in the full length of the study
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder
- Acute diarrhoea, infection, or illness at the time of enrolment
- Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit
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 |
|---|---|---|
| polio vaccines: nOPV2, bOPV, IPVCo-administration of nOPV2 with bOPV along with IPV with different sequential or combination schedules. | Biological | Arm A : 3 doses of nOPV2 and bOPV with IPV, Arm B : 2 doses of nOPV2 and bOPV with IPV, Arm C: Single dose of bOPV, nOPV2, IPV, Arm D: Single dose nOPV2, IPV |
Primary outcome
Cumulative seroconversion to all serotypes at the end of a vaccination series including two or three doses of co-administered nOPV2 and bOPV plus one dose of IPV.
Time frame: Serology: 6 &18 weeks
Poliovirus antibody titers to types 1, 2 and 3 will be measured in sera extracted from blood collected at 6, 10, 14, and 18 weeks of age
4 secondary outcomes
Seroconversion for type 2 after one dose of nOPV2 alone, co-administered with bOPV, or administered 4-weeks after bOPV;
Time frame: Serology: 6 & 14 weeks for C, 6 & 10 weeks for D,
Cumulative seroconversion for type 2 after two doses of nOPV2 administered alone or co-administered with bOPV;
Time frame: Serology: 6 & 14 weeks for C, 6 & 10 weeks for A
Cumulative seroconversion to all serotypes after 1 dose each of bOPV, nOPV2 and IPV administered sequentially one month apart.
Time frame: Serology: 6 & 18 weeks
Antibody titers for all 3 serotypes reached at the end of each vaccination schedule
Time frame: Serology: 6 & 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. Study data will be jointly owned by icddr,b and CDC. After completion of study activities, summary tables of study results will be available on www.clinicaltrials.gov. After study registration, clinicaltrials.gov provides unrestricted public access on study details including summary tables. Study investigators will have access to all participants' data without identifiers, including laboratory data. Co-investigators and technical advisors will have access to relevant data as defined in protocol
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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. This study is not recruiting at the moment.
Dr. K Zaman, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing polio vaccines: nOPV2, bOPV, IPV in people with Polio, run by International Centre for Diarrhoeal Disease Research, 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. K Zaman, PhD (+880 (0)2-2222-77001 ext. 3806, kzaman@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative seroconversion to all serotypes at the end of a vaccination series including two or three doses of co-administered nOPV2 and bOPV plus one dose of IPV. (time frame: Serology: 6 &18 weeks). 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 7 Nov 2023.