Oral Polio VaccinemOPV1NCT04504539
Use of mOPV1 in Routine Immunization in Pakistan.
A study testing mOPV, bOPV and Full dose IPV in people with Oral Polio Vaccine, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community. Bivalent OPV (bOPV), which protects against types 1 and 3, is used for routine immunization. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Polio Vaccine
- What is being tested?
- mOPV, bOPV and Full dose IPV
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2020to Dec 2021
- Phase
- Interventional
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born healthy with birth weight 2.0 kg or more, with immediate cry.
- Parents resident of the study areas Not planning to travel away during entire the study period (birth-154 days; birth - 22 weeks) for 3 months at the time of enrolment
- Parent/guardian provides informed consent
Who cannot join
- 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 confirmed diagnosis of immunodeficiency disorder in a blood relative will render the newborn ineligible for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of mOPV1 Schedules for Routine Immunization in Pakistan. A Community Based Randomized Control Trial
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community. Bivalent OPV (bOPV), which protects against types 1 and 3, is used for routine immunization. However, type-3 wild poliovirus is on the verge of eradication, therefore mOPV1 is important to achieve eradication of type-1 poliovirus.
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains live poliovirus, and will eventually lead to complete eradication and containment of type 1 WPV, vaccine-related (VDPV) and Sabin polioviruses. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks.
Read the detailed description
Wild Polio Virus 1 (WPV1) is the only responsible virus for wild polio cases across the globe. The world has successfully eradicated wild poliovirus (PV) 2 and 3. Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one and has highest number of WPV1 cases in 2019. The main stream strategies by the Global Polio Eradication Initiative has made the substantial progress towards the eradication of poliomyelitis ever since the World Health Assembly has sanctioned it as an emerging global Public Health threat. These strategies focus on high-quality immunization activities (routine and supplemental) that target children from birth to age 5 years with oral poliovirus vaccines (OPVs), and maintaining a system for acute flaccid paralysis surveillance.
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community and implies impending failure of goal of global eradication. According to the Polio endgame strategy 2019-2023, Pakistan and Afghanistan are the only countries in which WPV transmissions continues to be reported. The genetic sampling and environmental surveillance have revealed that WPV1 has predominantly persisted in Pakistan and Afghanistan and are closely linked as they constitute one epidemiological block. Bivalent OPV (bOPV), which protect against types 1 and 3, is used for routine immunization. However, type-3 wild poliovirus is on the verge of eradication, therefore mOPV1 is important to achieve eradication of type-1 poliovirus whose appearance has been continually been confirmed by the genetic and environmental samplings.
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains live poliovirus, and will eventually lead to complete eradication and containment of type 1 WPV, vaccine-related (VDPV) and Sabin polioviruses. The study rationale is in line with the Goal 1- Eradication of GPEI. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks.
Research Questions and Main Objectives :
Overall Objectives of the study will be:
- To assess the serum immunity against type 1,2 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule (mOPV1+fIPV (fractional dose intradermal IPV); mOPV1+FIPV (full dose intramuscular IPV))
- To compare the serum immunity against type 1,2 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule with bOPV2 routine immunization schedules (mOPV1+fIPV, mOPV1+FIPV with bOPV2+fIPV, bOPV2+FIPV)
- To assess the type 2 response after One full dose IPV with mOPV1 and bOPV2 routine immunization schedule
- To assess the type 2 response after two fractional doses of IPV with mOPV1 and bOPV2 routine immunization schedule
- Conditions
- Oral Polio Vaccine
- Being tested
- mOPV, bOPV, Full dose IPV, fractional IPV
- Keywords
- mOPV, bOPV, randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mOPVBiological
mOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1
bOPVBiological
bOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3
Full dose IPVBiological
FIPV (full dose injectable polio vaccine)
fractional IPVBiological
fIPV (fractional dose injectable polio vaccine)
| Study group | Role | What they receive |
|---|---|---|
| mOPV with FIPV | Experimental | mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age. Receives: Biological: mOPV; Biological: Full dose IPV; Biological: fractional IPV |
| bOPV with FIPV | Experimental | bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age. Receives: Biological: bOPV; Biological: Full dose IPV; Biological: fractional IPV |
| mOPV with fIPV | Experimental | mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age. Receives: Biological: mOPV; Biological: Full dose IPV; Biological: fractional IPV |
| bOPV with fIPV | Experimental | bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age. Receives: Biological: bOPV; Biological: Full dose IPV; Biological: fractional IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with change in antibody titres following vaccination
The number of children who produce antibodies following vaccination of each of the 4 arms
Measured: This will be checked in samples taken at birth, 6 weeks post vaccination, 10 weeks, 14 weeks and 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 posted7 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Polio VaccineStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Different regimens of mOPV and bOPV in combination with either fractional IPV (fIPV) or full dose IPV (FIPV) will be used.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Ali Faisal Saleem, Aga Khan University
- Investigators
- Ali Saleem, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504539
- Sponsor's protocol ID
- 2020-3284-11191
- Acronym
- mOPV1
- Status last verified
- Aug 2020
- First submitted
- 23 Jul 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of mOPV1 Schedules for Routine Immunization in Pakistan. A Community Based Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04504539
- Acronym / sponsor ID
- mOPV1 / 2020-3284-11191
- Conditions
- Oral Polio Vaccine
- Keywords
- mOPV, bOPV, randomized trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Aug 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Aug 2020 (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.
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community. Bivalent OPV (bOPV), which protects against types 1 and 3, is used for routine immunization. However, type-3 wild poliovirus is on the verge of eradication, therefore mOPV1 is important to achieve eradication of type-1 poliovirus.
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains live poliovirus, and will eventually lead to complete eradication and containment of type 1 WPV, vaccine-related (VDPV) and Sabin polioviruses. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks.
Detailed description
Wild Polio Virus 1 (WPV1) is the only responsible virus for wild polio cases across the globe. The world has successfully eradicated wild poliovirus (PV) 2 and 3. Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one and has highest number of WPV1 cases in 2019. The main stream strategies by the Global Polio Eradication Initiative has made the substantial progress towards the eradication of poliomyelitis ever since the World Health Assembly has sanctioned it as an emerging global Public Health threat. These strategies focus on high-quality immunization activities (routine and supplemental) that target children from birth to age 5 years with oral poliovirus vaccines (OPVs), and maintaining a system for acute flaccid paralysis surveillance.
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community and implies impending failure of goal of global eradication. According to the Polio endgame strategy 2019-2023, Pakistan and Afghanistan are the only countries in which WPV transmissions continues to be reported. The genetic sampling and environmental surveillance have revealed that WPV1 has predominantly persisted in Pakistan and Afghanistan and are closely linked as they constitute one epidemiological block. Bivalent OPV (bOPV), which protect against types 1 and 3, is used for routine immunization. However, type-3 wild poliovirus is on the verge of eradication, therefore mOPV1 is important to achieve eradication of type-1 poliovirus whose appearance has been continually been confirmed by the genetic and environmental samplings.
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains live poliovirus, and will eventually lead to complete eradication and containment of type 1 WPV, vaccine-related (VDPV) and Sabin polioviruses. The study rationale is in line with the Goal 1- Eradication of GPEI. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks.
Research Questions and Main Objectives :
Overall Objectives of the study will be:
- To assess the serum immunity against type 1,2 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule (mOPV1+fIPV (fractional dose intradermal IPV); mOPV1+FIPV (full dose intramuscular IPV))
- To compare the serum immunity against type 1,2 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule with bOPV2 routine immunization schedules (mOPV1+fIPV, mOPV1+FIPV with bOPV2+fIPV, bOPV2+FIPV)
- To assess the type 2 response after One full dose IPV with mOPV1 and bOPV2 routine immunization schedule
- To assess the type 2 response after two fractional doses of IPV with mOPV1 and bOPV2 routine immunization schedule
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Different regimens of mOPV and bOPV in combination with either fractional IPV (fIPV) or full dose IPV (FIPV) will be used.
| Arm | Type | Receives |
|---|---|---|
| mOPV with FIPV | Experimental | Biological: mOPV, Biological: Full dose IPV, Biological: fractional IPVmOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age. |
| bOPV with FIPV | Experimental | Biological: bOPV, Biological: Full dose IPV, Biological: fractional IPVbOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age. |
| mOPV with fIPV | Experimental | Biological: mOPV, Biological: Full dose IPV, Biological: fractional IPVmOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age. |
| bOPV with fIPV | Experimental | Biological: bOPV, Biological: Full dose IPV, Biological: fractional IPVbOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- born healthy with birth weight 2.0 kg or more, with immediate cry.
Key exclusion criteria (4 listed)
- Refusal of blood testing and cord blood testing
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 |
|---|---|---|
| mOPVmOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1 | Biological | mOPV with FIPV, mOPV with fIPV |
| bOPVbOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3 | Biological | bOPV with FIPV, bOPV with fIPV |
| Full dose IPVFIPV (full dose injectable polio vaccine) | Biological | bOPV with FIPV, bOPV with fIPV, mOPV with FIPV, mOPV with fIPV |
| fractional IPVfIPV (fractional dose injectable polio vaccine) | Biological | bOPV with FIPV, bOPV with fIPV, mOPV with FIPV, mOPV with fIPV |
Primary outcome
Number of children with change in antibody titres following vaccination
Time frame: This will be checked in samples taken at birth, 6 weeks post vaccination, 10 weeks, 14 weeks and 18 weeks of age
The number of children who produce antibodies following vaccination of each of the 4 arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- 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. This study is not recruiting at the moment.
Ali Saleem 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 study testing mOPV, bOPV and Full dose IPV in people with Oral Polio Vaccine, 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 3 inclusion and 4 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 Aug 2020. 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.
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 Ali Saleem (02134930051 ext. 4718, ali.saleem@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children with change in antibody titres following vaccination (time frame: This will be checked in samples taken at birth, 6 weeks post vaccination, 10 weeks, 14 weeks and 18 weeks of age). 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 Aug 2020.