PoliomyelitisPhase 4NCT02189811
Polio End-game Strategies - Poliovirus Type 2 Challenge Study
A Phase 4 study testing IPV, bOPV and bOPV and IPV in people with Poliomyelitis, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since 1999, and no case of wild type poliovirus 3 since November 2012. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- IPV, bOPV and bOPV and IPV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2014to May 2016
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn of either gender born healthy with birth weight 2.0 kg or more, with immediate cry, at the study sites (home or health facility births)
- Not planning to travel away during entire the study period (birth-154 days; birth 22 weeks).
- Parents resident of the study area for last 3 month at the time of enrolment
- Parent/guardian provides informed consent
Who cannot join
- Newborns found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization, birth weight below 2.0 kg, cry >2 minutes after birth, or family is planning to be absent during the birth - 154 days study period
- Refusal of blood testing and cord blood testing
- Receipt of OPV after birth before eligibility screen
- Newborns with certain medical conditions i.e., syndromic infants, neonate with petechial or purpura (contraindication of intramuscular injections)
- A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony
Karachi, Sindh
About this study
Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since 1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and reported from several areas with low population immunity to polio, including in Pakistan. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
Read the detailed description
The "Polio Endgame Strategy" consists of set of tasks and activities that will be implemented in the next five years. It includes gradual withdrawal of the widely used oral poliomyelitis vaccine (OPV) containing live poliovirus, and will eventually lead to complete eradication and containment of all wild, vaccine-related (VDPV) and Sabin polioviruses. The withdrawal of the type 2 components of trivalent OPV (tOPV) is the key component in the elimination of cVDPVs. This entails strengthening of the immunization system by introducing at least one dose of affordable IPV into the routine immunization schedule globally and then replacing the trivalent OPV with bivalent OPV in all OPV-using countries - setting the stage for eventually ending bOPV use in 2019-2020. Most of the developing countries have an OPV schedule however many developed and European countries follow the IPV only schedule. The current recommendations for polio eradication and endgame is IPV vaccine to be administered together with third OPV dose, which in most countries occurs at 14 weeks of age.
This study will assess the protection to type 2 poliovirus achieved after completion of the recommended schedule with bOPV and IPV; it will compare immunogenicity of bOPV + IPV schedule with tOPV only schedule; and will quantify the cross-reactivity of bOPV on inducing type 2 immunological reaction. In addition, it will also provide first data on the proposed outbreak response to type 2 (either with mOPV 2 or with a combination of mOPV 2 and IPV 2).
This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
- Conditions
- Poliomyelitis
- Being tested
- IPV, bOPV, bOPV and IPV, bOPV and IPV and IPV2, tOPV
- Keywords
- IPV, OPV, tOPV, bOPV, Polio, Endgame, Pakistan
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPVBiological
IPV at birth, 6, 10, 14 weeks of age and tOPV at 18 and 22 weeks of age
bOPVBiological
bOPV at birth, 6, 10, 14 weeks and tOPV at 18 and 22 weeks of age
bOPV and IPVBiological
bOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age
bOPV and IPV and IPV2Biological
bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age
tOPVBiological
tOPV till 22 weeks of age
| Study group | Role | What they receive |
|---|---|---|
| IPV | Experimental | IPV at birth, 6 weeks, 10 weeks, 14 weeks, followed by tOPV at 18 and 22 weeks Receives: Biological: IPV |
| bOPV | Experimental | bOPV at birth, 6, 10, and 14 weeks. followed by tOPV at 18 and 22 weeks of age Receives: Biological: bOPV |
| bOPV and IPV | Experimental | bOPV at birth, 6, 10 weeks, and IPV+bOPV at 14 weeks, and tOPV at 18 and 22 weeks of age Receives: Biological: bOPV and IPV |
| bOPV and IPV and IPV2 | Experimental | bOPV at birth, 6, 10 weeks and bOPV+IPV at 14 weeks and tOPV+IPV2 at 18 weeks and tOPV alone at 22 weeks of age Receives: Biological: bOPV and IPV and IPV2 |
| tOPV | Active comparator | tOPV at birth, 6, 10, 14, 18 and 22 weeks of age Receives: Biological: tOPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in seroprevalence of neutralizing antibodies for type 2 in 19 weeks of age between arms
Measured: 19 weeks of age
Secondary outcomes (1)
Seroprevalence of neutralizing antibodies at 18 weeks of age
Measured: 18 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Centers for Disease Control and Prevention, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ali Faisal Saleem, Aga Khan University
- Investigators
- Ali F Saleem, MBBS,FCPS,MSc, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189811
- Sponsor's protocol ID
- PEGS
- Status last verified
- May 2016
- First submitted
- 9 Jul 2014
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saleem AF, Yousafzai MT, Mach O, Khan A, Quadri F, Weldon WC, Oberste MS, Zaidi SS, Alam MM, Sutter RW, Zaidi AKM. Evaluation of vaccine derived poliovirus type 2 outbreak response options: A randomized controlled trial, Karachi, Pakistan. Vaccine. 2018 Mar 20;36(13):1766-1771. doi: 10.1016/j.vaccine.2018.02.051. Epub 2018 Feb 21.
PubMed 29477307
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polio End-game Strategies - Poliovirus Type 2 Challenge Study
- ClinicalTrials.gov ID
- NCT02189811
- Acronym / sponsor ID
- PEGS
- Conditions
- Poliomyelitis
- Keywords
- IPV, OPV, tOPV, bOPV, Polio, Endgame, Pakistan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- World Health Organization, Centers for Disease Control and Prevention, National Institutes of Health (NIH)
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- 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.
Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since 1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and reported from several areas with low population immunity to polio, including in Pakistan. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
Detailed description
The "Polio Endgame Strategy" consists of set of tasks and activities that will be implemented in the next five years. It includes gradual withdrawal of the widely used oral poliomyelitis vaccine (OPV) containing live poliovirus, and will eventually lead to complete eradication and containment of all wild, vaccine-related (VDPV) and Sabin polioviruses. The withdrawal of the type 2 components of trivalent OPV (tOPV) is the key component in the elimination of cVDPVs. This entails strengthening of the immunization system by introducing at least one dose of affordable IPV into the routine immunization schedule globally and then replacing the trivalent OPV with bivalent OPV in all OPV-using countries - setting the stage for eventually ending bOPV use in 2019-2020. Most of the developing countries have an OPV schedule however many developed and European countries follow the IPV only schedule. The current recommendations for polio eradication and endgame is IPV vaccine to be administered together with third OPV dose, which in most countries occurs at 14 weeks of age.
This study will assess the protection to type 2 poliovirus achieved after completion of the recommended schedule with bOPV and IPV; it will compare immunogenicity of bOPV + IPV schedule with tOPV only schedule; and will quantify the cross-reactivity of bOPV on inducing type 2 immunological reaction. In addition, it will also provide first data on the proposed outbreak response to type 2 (either with mOPV 2 or with a combination of mOPV 2 and IPV 2).
This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IPV | Experimental | Biological: IPVIPV at birth, 6 weeks, 10 weeks, 14 weeks, followed by tOPV at 18 and 22 weeks |
| bOPV | Experimental | Biological: bOPVbOPV at birth, 6, 10, and 14 weeks. followed by tOPV at 18 and 22 weeks of age |
| bOPV and IPV | Experimental | Biological: bOPV and IPVbOPV at birth, 6, 10 weeks, and IPV+bOPV at 14 weeks, and tOPV at 18 and 22 weeks of age |
| bOPV and IPV and IPV2 | Experimental | Biological: bOPV and IPV and IPV2bOPV at birth, 6, 10 weeks and bOPV+IPV at 14 weeks and tOPV+IPV2 at 18 weeks and tOPV alone at 22 weeks of age |
| tOPV | Active comparator | Biological: tOPVtOPV at birth, 6, 10, 14, 18 and 22 weeks of age |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborn of either gender born healthy with birth weight 2.0 kg or more, with immediate cry, at the study sites (home or health facility births)
- Not planning to travel away during entire the study period (birth-154 days; birth 22 weeks).
- Parents resident of the study area for last 3 month at the time of enrolment
- Parent/guardian provides informed consent
Key exclusion criteria (5 listed)
- Newborns found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization, birth weight below 2.0 kg, cry >2 minutes after birth, or family is planning to be absent during the birth - 154 days study period
- Refusal of blood testing and cord blood testing
- Receipt of OPV after birth before eligibility screen
- Newborns with certain medical conditions i.e., syndromic infants, neonate with petechial or purpura (contraindication of intramuscular injections)
- A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.
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 |
|---|---|---|
| IPVIPV at birth, 6, 10, 14 weeks of age and tOPV at 18 and 22 weeks of age | Biological | IPV |
| bOPVbOPV at birth, 6, 10, 14 weeks and tOPV at 18 and 22 weeks of age | Biological | bOPV |
| bOPV and IPVbOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age | Biological | bOPV and IPV |
| bOPV and IPV and IPV2bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age | Biological | bOPV and IPV and IPV2 |
| tOPVtOPV till 22 weeks of age | Biological | tOPV |
Primary outcome
Difference in seroprevalence of neutralizing antibodies for type 2 in 19 weeks of age between arms
Time frame: 19 weeks of age
1 secondary outcome
Seroprevalence of neutralizing antibodies at 18 weeks of age
Time frame: 18 weeks of age
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 3 May 2016.
- Derived from this study: PubMed 29477307Saleem AF, Yousafzai MT, Mach O, Khan A, Quadri F, Weldon WC, Oberste MS, Zaidi SS, Alam MM, Sutter RW, Zaidi AKM. Evaluation of vaccine derived poliovirus type 2 outbreak response options: A randomized controlled trial, Karachi, Pakistan. Vaccine. 2018 Mar 20;36(13):1766-1771. doi: 10.1016/j.vaccine.2018.02.051. Epub 2018 Feb 21.
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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.
Ali F Saleem, MBBS,FCPS,MSc principal investigator
Aga Khan University
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 IPV, bOPV and bOPV and IPV in people with Poliomyelitis, run by Aga Khan University at 1 site in Pakistan.
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 4 inclusion and 5 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 May 2016. 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 Pakistan. 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?
Difference in seroprevalence of neutralizing antibodies for type 2 in 19 weeks of age between arms (time frame: 19 weeks of age). 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 NCT02189811, 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 May 2016.