PolioSIADNCT01586572
Pakistan Short Interval mOPV1 Compared With Standard Interval mOPV1 and bOPV 1,3
A study testing mOPV1 and bOPV 1,3 in people with Polio, run by Aga Khan University at 2 sites in Pakistan.
Trial summary
Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in tribal areas present special challenges in interrupting transmission rapidly. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Polio
- What is being tested?
- mOPV1 and bOPV 1,3
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesPakistan
- Study dates
- Apr 2012to May 2013
- 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 1 hour to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants > 2.5 kg birth weight
- Immediate cry
- No neonatal IMCI danger signs
- Not planning to travel away during entire the study period (birth-102 days)
Who cannot join
- High-risk newborns will be excluded, as well as newborns requiring hospitalization
- Birth weight below 2.5 kg
- Cry >2 minutes
- With any neonatal IMNCI danger signs
- Residence >30 km from study site
- Family is planning to be absent during the birth - 102 day study period.
- 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
2 sites in 1 country.
Pakistan2 sites
Aga Khan University
Karachi, Sindh, 74800
Aga Khan University
Karachi, Sindh
About this study
Official title: Comparison of Immunogenicity of Type 1 mOPV Administered at Short Intervals With Type 1 mOPV1 and Type 1 & 3 bOPV Oral Polio Vaccine Given at Standard Intervals in Pakistan:A Randomized Trial
Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in tribal areas present special challenges in interrupting transmission rapidly. There exists limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity levels in young children. The aim of this study is to demonstrate the non-inferiority of shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals beginning at 6 weeks of age.
Read the detailed description
This randomized clinical trial which will be conducted in 5 low-income areas in and around Karachi (4 peri-urban, contiguous coastal villages outside Karachi, and one urban squatter settlement) where the Aga Khan University's Department of Paediatrics and Child Health has well-established demographic surveillance with all pregnancies and new births in the area captured through the system. The study participants will be enrolled from birth until 102 days. Subjects will be randomized to one of four trial arms.
All children will receive tOPV at birth. At 42 days (6 weeks) of age, three study arms will receive a dose of mOPV1 whereas the fourth arm will receive a dose of bOPV1\&3 as per protocol. Then 7 or 14 or 30 days later, the study participants in Arms A, B, and C will receive a second dose of mOPV1 while a second dose of bOPV 1\&3 will be given to participants in Arm D at 30 days.
Name and description of products:
- Standard trivalent oral poliovirus vaccine (tOPV), in a 10:1:6 formulation, containing at least 106 TCID50 of Sabin -strain poliovirus type 1, at least 105 TCID50 of Sabin-strain poliovirus type 2 and at least 105.8 TCID50 of Sabin-strain poliovirus type 3.
- Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
- The bivalent oral polio vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3.
Sample Size:
To show non-inferiority of a 2-dose mOPV1 schedule with shorter-intervals (either 7 or 14 days) [intervention] compared to a 2-dose mOPV1 schedule administered at 30-day intervals [control], and a 2-dose bOPV13 schedule administered at a 30-day interval (control) assuming a power of 0.90 (beta) and p of 0.05 (alpha), we require a sample of 139 for each study group, for a total of 556 subjects. To compensate for drop out, attrition and insufficient sera for laboratory testing, an inflated (by ~ 50%) sample size of 200 in each group will be used (total sample size of 800)
Efficacy Endpoints:
The primary endpoint is seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1\&3 given at the standard interval of 30 days..
The secondary endpoint is seroconversion following the birth dose of tOPV.
All samples will be processed at the Centers of Disease Control and Prevention CDC) Laboratories (a Global Specialized Polio Network Laboratory).
- Conditions
- Polio
- Being tested
- mOPV1, bOPV 1,3
- Keywords
- Polio virus type 1,2,3, Poliovaccine-Oral, Poliovaccine, Trivalent Oral Polio vaccine, Monovalent oral polio vaccine, Bivalent 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.
mOPV1Drug
Also called Monovalent type 1 oral poliovirus vaccine
Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
bOPV 1,3Drug
Also called Bivalent Oral Polio Vaccine
The bivalent vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3.
| Study group | Role | What they receive |
|---|---|---|
| mOPV1- Arm A | Experimental | Arm A will be administered a second dose of mOPV1 seven days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at day 79. Receives: Drug: mOPV1 |
| mOPV1- Arm B | Experimental | Arm B will be administered a second dose of mOPV1 fourteen days after after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 86 days. Receives: Drug: mOPV1 |
| mOPV1-Arm C | Experimental | Arm C will receive the second dose of mOPV1 thirty days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 102 days. Receives: Drug: mOPV1 |
| Arm D- bOPV1,3 | Experimental | Arm D will be administered a second dose of bOPV1,3 thirty days after the 42 day bOPV1,3 index dose.Second dose of tOPV2 will be given at day 102. Receives: Drug: bOPV 1,3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1&3 given at the standard interval of 30 days.
Humoral immunity: Sera collected at birth (cord blood or peripheral blood), at 42 days, at 79 days, at 86 days, or at 102 days (depending on study arm) will be examined for the presence (detectable) or absence of neutralizing antibodies to all three poliovirus serotypes. A reciprocal titer of >8 is considered to indicate the presence of neutralizing antibodies. For participants with detectable antibodies, seroconversion is defined as a 4-fold increase over the expected decline of maternally-derived antibodies (half-life assumed to be 28 days).
Measured: Participants will be followed till 102 days after birth
Secondary outcomes (1)
Seroconversion following the birth dose of tOPV.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Anita Kaniz Mehdi Zaidi, Aga Khan University
- Investigators
- Anita KM Zaidi, MD; MSc, Principal investigator, Aga Khan UniversityFatima FM Mir, MBBS, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586572
- Sponsor's protocol ID
- 1891-Ped-ERC-11
- Acronym
- SIAD
- Status last verified
- Jun 2015
- First submitted
- 2 Apr 2012
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mir F, Quadri F, Mach O, Ahmed I, Bhatti Z, Khan A, Rehman NU, Durry E, Salama M, Oberste SM, Weldon WC, Sutter RW, Zaidi AK. Monovalent type-1 oral poliovirus vaccine given at short intervals in Pakistan: a randomised controlled, four-arm, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Aug;15(8):889-97. doi: 10.1016/S1473-3099(15)00093-6. Epub 2015 Jun 17.
PubMed 26093979
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunogenicity of Type 1 mOPV Administered at Short Intervals With Type 1 mOPV1 and Type 1 & 3 bOPV Oral Polio Vaccine Given at Standard Intervals in Pakistan:A Randomized Trial
- ClinicalTrials.gov ID
- NCT01586572
- Acronym / sponsor ID
- SIAD / 1891-Ped-ERC-11
- Conditions
- Polio
- Keywords
- Polio virus type 1,2,3, Poliovaccine-Oral, Poliovaccine, Trivalent Oral Polio vaccine, Monovalent oral polio vaccine, Bivalent Oral polio vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Apr 2012 (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.
Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in tribal areas present special challenges in interrupting transmission rapidly. There exists limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity levels in young children. The aim of this study is to demonstrate the non-inferiority of shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals beginning at 6 weeks of age.
Detailed description
This randomized clinical trial which will be conducted in 5 low-income areas in and around Karachi (4 peri-urban, contiguous coastal villages outside Karachi, and one urban squatter settlement) where the Aga Khan University's Department of Paediatrics and Child Health has well-established demographic surveillance with all pregnancies and new births in the area captured through the system. The study participants will be enrolled from birth until 102 days. Subjects will be randomized to one of four trial arms.
All children will receive tOPV at birth. At 42 days (6 weeks) of age, three study arms will receive a dose of mOPV1 whereas the fourth arm will receive a dose of bOPV1\&3 as per protocol. Then 7 or 14 or 30 days later, the study participants in Arms A, B, and C will receive a second dose of mOPV1 while a second dose of bOPV 1\&3 will be given to participants in Arm D at 30 days.
Name and description of products:
- Standard trivalent oral poliovirus vaccine (tOPV), in a 10:1:6 formulation, containing at least 106 TCID50 of Sabin -strain poliovirus type 1, at least 105 TCID50 of Sabin-strain poliovirus type 2 and at least 105.8 TCID50 of Sabin-strain poliovirus type 3.
- Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
- The bivalent oral polio vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3.
Sample Size:
To show non-inferiority of a 2-dose mOPV1 schedule with shorter-intervals (either 7 or 14 days) [intervention] compared to a 2-dose mOPV1 schedule administered at 30-day intervals [control], and a 2-dose bOPV13 schedule administered at a 30-day interval (control) assuming a power of 0.90 (beta) and p of 0.05 (alpha), we require a sample of 139 for each study group, for a total of 556 subjects. To compensate for drop out, attrition and insufficient sera for laboratory testing, an inflated (by ~ 50%) sample size of 200 in each group will be used (total sample size of 800)
Efficacy Endpoints:
The primary endpoint is seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1\&3 given at the standard interval of 30 days..
The secondary endpoint is seroconversion following the birth dose of tOPV.
All samples will be processed at the Centers of Disease Control and Prevention CDC) Laboratories (a Global Specialized Polio Network Laboratory).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mOPV1- Arm A | Experimental | Drug: mOPV1Arm A will be administered a second dose of mOPV1 seven days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at day 79. |
| mOPV1- Arm B | Experimental | Drug: mOPV1Arm B will be administered a second dose of mOPV1 fourteen days after after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 86 days. |
| mOPV1-Arm C | Experimental | Drug: mOPV1Arm C will receive the second dose of mOPV1 thirty days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 102 days. |
| Arm D- bOPV1,3 | Experimental | Drug: bOPV 1,3Arm D will be administered a second dose of bOPV1,3 thirty days after the 42 day bOPV1,3 index dose.Second dose of tOPV2 will be given at day 102. |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants > 2.5 kg birth weight
- Immediate cry
- No neonatal IMCI danger signs
- Not planning to travel away during entire the study period (birth-102 days)
Key exclusion criteria (7 listed)
- High-risk newborns will be excluded, as well as newborns requiring hospitalization
- Birth weight below 2.5 kg
- Cry >2 minutes
- With any neonatal IMNCI danger signs
- Residence >30 km from study site
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 |
|---|---|---|
| mOPV1Also: Monovalent type 1 oral poliovirus vaccineMonovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1. | Drug | mOPV1- Arm A, mOPV1- Arm B, mOPV1-Arm C |
| bOPV 1,3Also: Bivalent Oral Polio VaccineThe bivalent vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3. | Drug | Arm D- bOPV1,3 |
Primary outcome
Seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1&3 given at the standard interval of 30 days.
Time frame: Participants will be followed till 102 days after birth
Humoral immunity: Sera collected at birth (cord blood or peripheral blood), at 42 days, at 79 days, at 86 days, or at 102 days (depending on study arm) will be examined for the presence (detectable) or absence of neutralizing antibodies to all three poliovirus serotypes. A reciprocal titer of >8 is considered to indicate the presence of neutralizing antibodies. For participants with detectable antibodies, seroconversion is defined as a 4-fold increase over the expected decline of maternally-derived antibodies (half-life assumed to be 28 days).
1 secondary outcome
Seroconversion following the birth dose of tOPV.
Time frame: At birth
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 29 Jun 2015.
- Derived from this study: PubMed 26093979Mir F, Quadri F, Mach O, Ahmed I, Bhatti Z, Khan A, Rehman NU, Durry E, Salama M, Oberste SM, Weldon WC, Sutter RW, Zaidi AK. Monovalent type-1 oral poliovirus vaccine given at short intervals in Pakistan: a randomised controlled, four-arm, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Aug;15(8):889-97. doi: 10.1016/S1473-3099(15)00093-6. Epub 2015 Jun 17.
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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.
Anita KM Zaidi, MD; MSc principal investigator
Aga Khan University
Fatima FM Mir, MBBS study director
Aga Khan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mOPV1 and bOPV 1,3 in people with Polio, run by Aga Khan University at 2 sites 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 7 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 29 Jun 2015. 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 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?
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?
Seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1&3 given at the standard interval of 30 days. (time frame: Participants will be followed till 102 days after birth). 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 NCT01586572, 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 29 Jun 2015.