PoliomyelitisPhase 4NCT03202719
Duration of IPV Priming and Antibody Decay
A Phase 4 study testing Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age, Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age and Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 2 sites in Bangladesh.
Trial summary
This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms. 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?
- Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age, Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age and Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,645 participants
- Where
- 2 sitesBangladesh
- Study dates
- 5 Nov 2017to 1 Oct 2019
- 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 6 to 7 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study.
- Parents that are able to understand and comply with planned study procedures.
Who cannot join
- Parents and infants who 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 that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
- Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
Show all 10Show fewer
- Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall.
- Known allergy/sensitivity or reaction to polio vaccine, or its contents.
- Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
- Infants from premature births (<37 weeks of gestation).
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
International Center for Diarrhoeal Disease Research, Bangladesh
Dhaka
Mirpur clinic (International Center for Diarrhoeal Disease Research, Bangladesh)
Dhaka
About this study
Official title: Duration of Priming and Antibody Decay With Full-dose Inactivated Poliovirus Vaccine (IPV) Administered With or Without Bivalent Oral Poliovirus Vaccine (bOPV)
This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms.
Read the detailed description
Poliomyelitis is an acute infection caused by polioviruses. Oral poliovirus vaccines are live attenuated viral vaccines and the vaccine virus in OPV can mutate and acquire neurovirulence causing paralysis either due to vaccine-associated paralytic polio (VAPP) or due to circulating vaccine-derived polioviruses (cVDPV), in which the attenuated vaccine virus not only acquires the ability to cause paralysis but can also circulate similar to wild poliovirus (WPV). Therefore, polio eradication will require eventual cessation of all OPVs.
Wild poliovirus type 2 (WPV2) was declared eradicated in September 2015. Since then paralysis associated with type 2 poliovirus has continued mainly due to vaccine derived polio viruses (VDPVs) from type 2 OPV (OPV2). Due to the continued threat of paralysis from a mutated, neurovirulent and vaccine-derived type 2 poliovirus, the Strategic Advisory Group of Experts on Immunization (SAGE), a global advisory committee on immunization, recommended a phased cessation of OPV starting with OPV2. By May 2016, OPV2 was successfully withdrawn globally when trivalent OPV (tOPV) was replaced with bivalent OPV (bOPV), which was preceded by a phased introduction of inactivated poliovirus vaccine (IPV). SAGE has recommended at least one dose of IPV at age ≥14 weeks because IPV immunogenicity is expected to be highest after maternal antibodies have declined by age 14 weeks. However, studies have not assessed if priming after one IPV dose declines over time.
Types 1 and 3 OPV cessation is likely expected in 2020-2022, i.e. 1-2 years after certification of global interruption of wild poliovirus transmission. After cessation of bOPV, IPV will be used for routine polio vaccination for 5-10 years.Recently, SAGE recommended that IPV be used after global OPV withdrawal with an IPV schedule that achieves at least 90% seroconversion with two full or fractional doses. SAGE has recommended that the first dose be administered after 14 weeks of age and an interval of at least 4 months between two IPV doses. In the proposed clinical trial, immunogenicity of two IPV doses with schedules that are likely to achieve 90% immune response to all poliovirus types is being assessed to inform SAGE policy deliberations on potential IPV schedules after OPV cessation. A head-to-head comparison of different IPV schedules is important to determine the immunogenicity of the schedules under similar conditions and evaluate the differences in population immunity, a product of immunogenicity and vaccination coverage, with the different IPV schedules.
- Conditions
- Poliomyelitis
- Being tested
- Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age, Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age, Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age, Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age, Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age
- Keywords
- Inactivated polio vaccine, Polio, 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.
Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of ageBiological
bOPV at 6, 10 and 14 weeks of age
Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of ageBiological
IPV at 14 weeks and 18 months of age
Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of ageBiological
IPV at 14 weeks, 18 weeks and 18 months of age
Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of ageBiological
IPV at 14 weeks and 9 months of age
Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of ageBiological
IPV at 6 weeks and 9 months of age
Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of ageBiological
IPV at 6 and 14 weeks of age
| Study group | Role | What they receive |
|---|---|---|
| IPV at ages 14 weeks and 18 months | Active comparator | Participants in this arm will receive bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age Receives: Biological: Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age; Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age |
| IPV at ages 14 weeks, 18 weeks and 18 months | Active comparator | Participants in this arm will receive bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age Receives: Biological: Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age; Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age |
| IPV at ages 14 weeks and 9 months | Active comparator | Participants in this arm will inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age Receives: Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age |
| IPV at ages 6 weeks and 9 months | Active comparator | Participants in this arm will inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age Receives: Biological: Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age |
| IPV at ages 6 and 14 weeks | Active comparator | Participants in this arm will inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age Receives: Biological: Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of IPV vaccination schedule
Immunogenicity will be assessed by measuring type-specific poliovirus antibody titers and assessing the change in antibody titers after receiving study vaccine compared to 6 weeks of age. The cumulative proportion of participants who demonstrate an immune response one month after receiving the last IPV dose of the experimental schedule. Immune response will be defined as either seronegative participants (<1:8 titers) who become seropositive (≥1:8) [seroconversion] or participants who demonstrate a four-fold increase in titer (boosting).
Measured: Change after receiving vaccine compared to that at 6 weeks of age
Poliovirus type 2 priming with IPV
The proportion of participants who demonstrate type 2 immune response one week after receiving an additional IPV dose (secondary vaccination) after the proposed primary IPV vaccination series will be determined. Priming is the proportion of participants that demonstrate type 2 immune response among those who have not previously responded to the primary IPV vaccination series.
Measured: Proportion who demonstrate type 2 response at 18 months and 1 week among those who did not respond at 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start5 Nov 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202719
- Sponsor's protocol ID
- ICDDRB-RRC-PR-17034
- Status last verified
- Nov 2020
- First submitted
- 23 Jun 2017
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summary tables to be shared December 2019
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Priming and Antibody Decay With Full-dose Inactivated Poliovirus Vaccine (IPV) Administered With or Without Bivalent Oral Poliovirus Vaccine (bOPV)
- ClinicalTrials.gov ID
- NCT03202719
- Acronym / sponsor ID
- ICDDRB-RRC-PR-17034
- Conditions
- Poliomyelitis
- Keywords
- Inactivated polio vaccine, Polio, oral polio vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,645 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 29 Jun 2017 (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.
This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms.
Detailed description
Poliomyelitis is an acute infection caused by polioviruses. Oral poliovirus vaccines are live attenuated viral vaccines and the vaccine virus in OPV can mutate and acquire neurovirulence causing paralysis either due to vaccine-associated paralytic polio (VAPP) or due to circulating vaccine-derived polioviruses (cVDPV), in which the attenuated vaccine virus not only acquires the ability to cause paralysis but can also circulate similar to wild poliovirus (WPV). Therefore, polio eradication will require eventual cessation of all OPVs.
Wild poliovirus type 2 (WPV2) was declared eradicated in September 2015. Since then paralysis associated with type 2 poliovirus has continued mainly due to vaccine derived polio viruses (VDPVs) from type 2 OPV (OPV2). Due to the continued threat of paralysis from a mutated, neurovirulent and vaccine-derived type 2 poliovirus, the Strategic Advisory Group of Experts on Immunization (SAGE), a global advisory committee on immunization, recommended a phased cessation of OPV starting with OPV2. By May 2016, OPV2 was successfully withdrawn globally when trivalent OPV (tOPV) was replaced with bivalent OPV (bOPV), which was preceded by a phased introduction of inactivated poliovirus vaccine (IPV). SAGE has recommended at least one dose of IPV at age ≥14 weeks because IPV immunogenicity is expected to be highest after maternal antibodies have declined by age 14 weeks. However, studies have not assessed if priming after one IPV dose declines over time.
Types 1 and 3 OPV cessation is likely expected in 2020-2022, i.e. 1-2 years after certification of global interruption of wild poliovirus transmission. After cessation of bOPV, IPV will be used for routine polio vaccination for 5-10 years.Recently, SAGE recommended that IPV be used after global OPV withdrawal with an IPV schedule that achieves at least 90% seroconversion with two full or fractional doses. SAGE has recommended that the first dose be administered after 14 weeks of age and an interval of at least 4 months between two IPV doses. In the proposed clinical trial, immunogenicity of two IPV doses with schedules that are likely to achieve 90% immune response to all poliovirus types is being assessed to inform SAGE policy deliberations on potential IPV schedules after OPV cessation. A head-to-head comparison of different IPV schedules is important to determine the immunogenicity of the schedules under similar conditions and evaluate the differences in population immunity, a product of immunogenicity and vaccination coverage, with the different IPV schedules.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IPV at ages 14 weeks and 18 months | Active comparator | Biological: Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age, Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of ageParticipants in this arm will receive bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age |
| IPV at ages 14 weeks, 18 weeks and 18 months | Active comparator | Biological: Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age, Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of ageParticipants in this arm will receive bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age |
| IPV at ages 14 weeks and 9 months | Active comparator | Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of ageParticipants in this arm will inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age |
| IPV at ages 6 weeks and 9 months | Active comparator | Biological: Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of ageParticipants in this arm will inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age |
| IPV at ages 6 and 14 weeks | Active comparator | Biological: Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of ageParticipants in this arm will inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age |
Who may qualify
- Ages
- 6 to 7 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study.
- Parents that are able to understand and comply with planned study procedures.
Key exclusion criteria (10 listed)
- Parents and infants who 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 that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
- Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
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 |
|---|---|---|
| Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of agebOPV at 6, 10 and 14 weeks of age | Biological | IPV at ages 14 weeks and 18 months, IPV at ages 14 weeks, 18 weeks and 18 months |
| Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of ageIPV at 14 weeks and 18 months of age | Biological | IPV at ages 14 weeks and 18 months |
| Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of ageIPV at 14 weeks, 18 weeks and 18 months of age | Biological | IPV at ages 14 weeks, 18 weeks and 18 months |
| Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of ageIPV at 14 weeks and 9 months of age | Biological | IPV at ages 14 weeks and 9 months |
| Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of ageIPV at 6 weeks and 9 months of age | Biological | IPV at ages 6 weeks and 9 months |
| Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of ageIPV at 6 and 14 weeks of age | Biological | IPV at ages 6 and 14 weeks |
Primary outcome
Immunogenicity of IPV vaccination schedule
Time frame: Change after receiving vaccine compared to that at 6 weeks of age
Immunogenicity will be assessed by measuring type-specific poliovirus antibody titers and assessing the change in antibody titers after receiving study vaccine compared to 6 weeks of age. The cumulative proportion of participants who demonstrate an immune response one month after receiving the last IPV dose of the experimental schedule. Immune response will be defined as either seronegative participants (<1:8 titers) who become seropositive (≥1:8) [seroconversion] or participants who demonstrate a four-fold increase in titer (boosting).
Poliovirus type 2 priming with IPV
Time frame: Proportion who demonstrate type 2 response at 18 months and 1 week among those who did not respond at 19 weeks
The proportion of participants who demonstrate type 2 immune response one week after receiving an additional IPV dose (secondary vaccination) after the proposed primary IPV vaccination series will be determined. Priming is the proportion of participants that demonstrate type 2 immune response among those who have not previously responded to the primary IPV vaccination series.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No. Summary tables to be shared December 2019
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age, Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age and Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 2 sites 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 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunogenicity of IPV vaccination schedule (time frame: Change after receiving vaccine compared to that at 6 weeks of age). The study lists 2 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 25 Nov 2020.