Healthy InfantsPhase 4NCT01633216
Poliovirus Vaccine Trial in Bangladesh
A Phase 4 study testing Bivalent OPV 2 week interval, Bivalent OPV 4 week interval and Monovalent OPV 2 week interval in people with Healthy Infants, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
Trial summary
This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals… Read more about this study
- Who is it for?
- Ages 6 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Bivalent OPV 2 week interval, Bivalent OPV 4 week interval and Monovalent OPV 2 week interval
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesBangladesh
- Study dates
- May 2012to Dec 2012
- 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 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants of 6 weeks of age (±2 days).
- Study families reside within the Health and Demographic Surveillance System (HDSS) area, service area of the ICDDR,B.
- Family able to understand and comply with planned study procedures
Who cannot join
- Family residence outside the ICDDR,B HDSS service area, or families expecting to move away during the study period, will be excluded.
- A diagnosis or suspicion of immunodeficiency disorder (either in the infant or in a member of the immediate family).
- A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
- Acute diarrhea, infection or illness at the time of the first visit (6 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines.
- Acute vomiting and intolerance to liquids within 24 hours before the first visit (6 weeks of age).
- Receipt of OPV or IPV at any time before enrollment based upon mother's recall or immunization card if available.
- Because of contact transmission of vaccine poliovirus strains, newborns from multiple births will be excluded from the study to prevent transmission of vaccine strains received during routine immunization from the twin to the study participant.
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Mirpur
Dhaka, Dhaka Division, 1216
Matlab
Matlab, Chandpur
About this study
Official title: Assessment of the Immunogenicity of Three Doses of Bivalent, Trivalent or Type One Monovalent Oral Poliovirus Vaccines Provided at 2 or 4 Week Intervals
This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.
Read the detailed description
This is a phase IV, randomized controlled clinical trial of three types of oral poliovirus vaccines provided at 2-week or 4-week intervals.
The study will enroll 1,000 participants from rural Matlab and urban Dhaka.
In this study infants will be given two different types of oral poliovirus vaccine, monovalent OPV type 1 (mOPV1) and bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The immune responses to these vaccines and schedules will be compared with the response to the routine oral polio vaccine schedule in Bangladesh of trivalent oral polio vaccine (tOPV) given at 4 week intervals.
The study will use a randomized controlled trial design. Eligible infants will be randomized at 6 weeks of age to one of five study arms: A) 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses); B) 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses); C) 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses); D) 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses); and E) 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses). Currently, tOPV is provided in routine immunization in Bangladesh at the same age as proposed in this study. bOPV, mOPV1 and mOPV3 are licensed in several countries and the World Health Organization (WHO) has recommended its use in immunization campaigns among children 0 to 5 years in response to circulation of type 1 and type 3 wild poliovirus, and to prevent outbreaks in countries at risk.
To assess the immunogenicity of each study vaccine and vaccination schedule, antibody titers against poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before (at 6 weeks of age) and after receiving 3 doses of study vaccine. Seroconversion will be defined as a titer 4-fold higher than the expected fall in maternally derived antibodies, assuming a half life of 28 days. The initial antibody titer at 6 weeks of age will be used as the starting point for the expected decline in maternal antibody. We will calculate a one-sided 95% confidence interval for the difference between the proportion of seroconversions achieved in the short interval study arms and the longer interval study arms. If the confidence interval does not include 10%, we will conclude that the short interval is not inferior to the longer interval. This same analysis will be applied to the difference between bOPV and mOPV1.
This study will answer the following questions:
- Is the immunogenicity of 3 doses of bOPV non inferior to that of 3 doses of mOPV1 against type 1 poliovirus?
- Is an interval of 2 weeks between bOPV or mOPV1 doses non inferior to an interval of 4 weeks?
- Will replacement of tOPV with bOPV in the routine immunization schedule achieve similar or higher proportions of children immune to type 1 and 3 polioviruses? The answers to these questions will guide the Global Polio Eradication Program in implementing new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; and 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV instead of monovalent OPVs; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPVin immunization campaigns and in routine immunization programs.
- Conditions
- Healthy Infants
- Being tested
- Bivalent OPV 2 week interval, Bivalent OPV 4 week interval, Monovalent OPV 2 week interval, Monovalent OPV 4 week interval, Trivalent OPV 4 week interval
- Keywords
- poliovirus,, trivalent oral polio vaccine,, bivalent oral polio vaccine,, monovalent oral polio vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent OPV 2 week intervalBiological
Group A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses).
Bivalent OPV 4 week intervalBiological
Group B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses).
Monovalent OPV 2 week intervalBiological
Group C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses).
Monovalent OPV 4 week intervalBiological
Group D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses).
Trivalent OPV 4 week intervalBiological
Group E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule).
| Study group | Role | What they receive |
|---|---|---|
| Bivalent OPV 2 week interval | Active comparator | Group A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses). Receives: Biological: Bivalent OPV 2 week interval |
| Bivalent OPV 4 week interval | Active comparator | Group B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses). Receives: Biological: Bivalent OPV 4 week interval |
| Monovalent OPV 2week interval | Active comparator | Group C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses). Receives: Biological: Monovalent OPV 2 week interval |
| Monovalent OPV 4 week interval | Active comparator | Group D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses). Receives: Biological: Monovalent OPV 4 week interval |
| Trivalent OPV 4 week interval | Active comparator | Group E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule). Receives: Biological: Trivalent OPV 4 week interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
To assess the immunogenicity of each study vaccine and vaccination schedule, antibody titers against poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before (at 6 weeks of age) and after receiving 3 doses of study vaccine.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy InfantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633216
- Sponsor's protocol ID
- PR-11064
- Status last verified
- Jun 2012
- First submitted
- 30 Jun 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Emperador DM, Velasquez DE, Estivariz CF, Lopman B, Jiang B, Parashar U, Anand A, Zaman K. Interference of Monovalent, Bivalent, and Trivalent Oral Poliovirus Vaccines on Monovalent Rotavirus Vaccine Immunogenicity in Rural Bangladesh. Clin Infect Dis. 2016 Jan 15;62(2):150-6. doi: 10.1093/cid/civ807. Epub 2015 Sep 8.
PubMed 26349548Estivariz CF, Anand A, Gary HE Jr, Rahman M, Islam J, Bari TI, Wassilak SG, Chu SY, Weldon WC, Pallansch MA, Heffelfinger JD, Luby SP, Zaman K. Immunogenicity of three doses of bivalent, trivalent, or type 1 monovalent oral poliovirus vaccines with a 2 week interval between doses in Bangladesh: an open-label, non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2015 Aug;15(8):898-904. doi: 10.1016/S1473-3099(15)00094-8. Epub 2015 Jun 17.
PubMed 26093980
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Immunogenicity of Three Doses of Bivalent, Trivalent or Type One Monovalent Oral Poliovirus Vaccines Provided at 2 or 4 Week Intervals
- ClinicalTrials.gov ID
- NCT01633216
- Acronym / sponsor ID
- PR-11064
- Conditions
- Healthy Infants
- Keywords
- poliovirus,, trivalent oral polio vaccine,, bivalent oral polio vaccine,, monovalent oral polio vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jul 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.
This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.
Detailed description
This is a phase IV, randomized controlled clinical trial of three types of oral poliovirus vaccines provided at 2-week or 4-week intervals.
The study will enroll 1,000 participants from rural Matlab and urban Dhaka.
In this study infants will be given two different types of oral poliovirus vaccine, monovalent OPV type 1 (mOPV1) and bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The immune responses to these vaccines and schedules will be compared with the response to the routine oral polio vaccine schedule in Bangladesh of trivalent oral polio vaccine (tOPV) given at 4 week intervals.
The study will use a randomized controlled trial design. Eligible infants will be randomized at 6 weeks of age to one of five study arms: A) 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses); B) 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses); C) 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses); D) 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses); and E) 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses). Currently, tOPV is provided in routine immunization in Bangladesh at the same age as proposed in this study. bOPV, mOPV1 and mOPV3 are licensed in several countries and the World Health Organization (WHO) has recommended its use in immunization campaigns among children 0 to 5 years in response to circulation of type 1 and type 3 wild poliovirus, and to prevent outbreaks in countries at risk.
To assess the immunogenicity of each study vaccine and vaccination schedule, antibody titers against poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before (at 6 weeks of age) and after receiving 3 doses of study vaccine. Seroconversion will be defined as a titer 4-fold higher than the expected fall in maternally derived antibodies, assuming a half life of 28 days. The initial antibody titer at 6 weeks of age will be used as the starting point for the expected decline in maternal antibody. We will calculate a one-sided 95% confidence interval for the difference between the proportion of seroconversions achieved in the short interval study arms and the longer interval study arms. If the confidence interval does not include 10%, we will conclude that the short interval is not inferior to the longer interval. This same analysis will be applied to the difference between bOPV and mOPV1.
This study will answer the following questions:
- Is the immunogenicity of 3 doses of bOPV non inferior to that of 3 doses of mOPV1 against type 1 poliovirus?
- Is an interval of 2 weeks between bOPV or mOPV1 doses non inferior to an interval of 4 weeks?
- Will replacement of tOPV with bOPV in the routine immunization schedule achieve similar or higher proportions of children immune to type 1 and 3 polioviruses? The answers to these questions will guide the Global Polio Eradication Program in implementing new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; and 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV instead of monovalent OPVs; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPVin immunization campaigns and in routine immunization programs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bivalent OPV 2 week interval | Active comparator | Biological: Bivalent OPV 2 week intervalGroup A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses). |
| Bivalent OPV 4 week interval | Active comparator | Biological: Bivalent OPV 4 week intervalGroup B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses). |
| Monovalent OPV 2week interval | Active comparator | Biological: Monovalent OPV 2 week intervalGroup C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses). |
| Monovalent OPV 4 week interval | Active comparator | Biological: Monovalent OPV 4 week intervalGroup D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses). |
| Trivalent OPV 4 week interval | Active comparator | Biological: Trivalent OPV 4 week intervalGroup E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule). |
Who may qualify
- Ages
- 6 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants of 6 weeks of age (±2 days).
- Study families reside within the Health and Demographic Surveillance System (HDSS) area, service area of the ICDDR,B.
- Family able to understand and comply with planned study procedures
Key exclusion criteria (7 listed)
- Family residence outside the ICDDR,B HDSS service area, or families expecting to move away during the study period, will be excluded.
- A diagnosis or suspicion of immunodeficiency disorder (either in the infant or in a member of the immediate family).
- A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
- Acute diarrhea, infection or illness at the time of the first visit (6 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines.
- Acute vomiting and intolerance to liquids within 24 hours before the first 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 OPV 2 week intervalGroup A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses). | Biological | Bivalent OPV 2 week interval |
| Bivalent OPV 4 week intervalGroup B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses). | Biological | Bivalent OPV 4 week interval |
| Monovalent OPV 2 week intervalGroup C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses). | Biological | Monovalent OPV 2week interval |
| Monovalent OPV 4 week intervalGroup D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses). | Biological | Monovalent OPV 4 week interval |
| Trivalent OPV 4 week intervalGroup E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule). | Biological | Trivalent OPV 4 week interval |
Primary outcome
Immunogenicity
Time frame: 7 months
To assess the immunogenicity of each study vaccine and vaccination schedule, antibody titers against poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before (at 6 weeks of age) and after receiving 3 doses of study vaccine.
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 8 Jan 2013.
- Derived from this study: PubMed 26349548Emperador DM, Velasquez DE, Estivariz CF, Lopman B, Jiang B, Parashar U, Anand A, Zaman K. Interference of Monovalent, Bivalent, and Trivalent Oral Poliovirus Vaccines on Monovalent Rotavirus Vaccine Immunogenicity in Rural Bangladesh. Clin Infect Dis. 2016 Jan 15;62(2):150-6. doi: 10.1093/cid/civ807. Epub 2015 Sep 8.
- Derived from this study: PubMed 26093980Estivariz CF, Anand A, Gary HE Jr, Rahman M, Islam J, Bari TI, Wassilak SG, Chu SY, Weldon WC, Pallansch MA, Heffelfinger JD, Luby SP, Zaman K. Immunogenicity of three doses of bivalent, trivalent, or type 1 monovalent oral poliovirus vaccines with a 2 week interval between doses in Bangladesh: an open-label, non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2015 Aug;15(8):898-904. doi: 10.1016/S1473-3099(15)00094-8. 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.
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 OPV 2 week interval, Bivalent OPV 4 week interval and Monovalent OPV 2 week interval in people with Healthy Infants, run by International Centre for Diarrhoeal Disease Research, Bangladesh 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 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 8 Jan 2013. 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 (time frame: 7 months). 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 NCT01633216, which also lists 2 linked publications.
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 8 Jan 2013.