PoliomyelitisPhase 4NCT02643368
Immunogenicity of Monovalent Type 2 Oral Poliovirus Vaccine
A Phase 4 study testing mOPV2 at 6 and 7 weeks of age, mOPV2 at 6 and 8 weeks of age and mOPV2 at 6 and 10 weeks of age in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.
Trial summary
This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval between mOPV2 doses. 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?
- mOPV2 at 6 and 7 weeks of age, mOPV2 at 6 and 8 weeks of age and mOPV2 at 6 and 10 weeks of age
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2015to Feb 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 6 to 7 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- Evidence of a chronic medical condition identified during physical exam.
- 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 diarrhea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV or IPV per country guidelines.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
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 contents of polio vaccine.
- Infants from multiple births. Infants from multiple births will be excluded to reduce the potential for contact transmission of vaccine poliovirus to siblings. The infant(s) from a multiple birth who is/are not enrolled would be likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant.
- Infants from premature births (<37 weeks of gestation).
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Center for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: Assessing Immunogenicity of Type 2 Monovalent Oral Poliovirus Vaccine Administered at One, Two or Four Week Intervals and When Coadministered With Inactivated Poliovirus Vaccine in an Urban Area in Bangladesh
This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the first dose of mOPV2, in a two dose schedule with a four week interval, is administered simultaneously with IPV.
Read the detailed description
The Strategic Advisory Group of Experts on Immunization (SAGE) has recommended a phased cessation of OPVs starting with serotype 2 (OPV2). This is because the last case of type 2 wild poliovirus (WPV2) was reported in 1999 and type 2 vaccine poliovirus is associated with the highest risk of causing paralysis due to reversion to vaccine derived poliovirus (VDPV), in which the reverted virus acquires not only the ability to cause paralysis but also the ability to transmit from person-to-person. Withdrawal of OPV2 will be done through the replacement worldwide of trivalent OPV (tOPV) with bivalent (types 1 and 3) OPV (bOPV) for use in routine immunization and in campaigns.
After the tOPV to bOPV switch, there will be strict biosafety requirements for the use of vaccines containing OPV2. Trivalent OPV will no longer exist and use of monovalent OPV2 (mOPV2) will be limited to responding to a type 2 outbreak. To respond to poliovirus type 2 outbreaks, the Global Polio Eradication Initiative has proposed delivering using mOPV2 in campaigns conducted in the primary zone of the outbreak and IPV in campaigns conducted in areas adjacent to outbreak zone. Therefore, mOPV2 will be a critical component of response to poliovirus type 2 outbreaks.
Typically, polio campaigns are conducted at an interval of 4 weeks. Recently, a clinical trial conducted by icddr,b and the U.S. Centers for Disease Control and Prevention (CDC) in Matlab and Mirpur in Bangladesh demonstrated non-inferiority of type 1 seroconversion after bOPV or mOPV1 at a 2 week interval compared to 4 weeks between doses. Based these findings, the Global Polio Eradication Initiative (GPEI) concluded that the immune response to "OPV is satisfactory when the interval between doses is shortened to 14 or even 7 days (in case of mOPV1)" and has used short-interval campaigns to deliver mOPV1 and bOPV in areas with security-limited access and for outbreak response. However, there are no data and no current or planned polio clinical trials are assessing the impact on immunogenicity of mOPV2 of a reduction in the interval between mOPV2 doses or of administration of mOPV2 in combination with IPV. Therefore, the findings from the trial proposed in this protocol have a direct and immediate implication on strategies to respond to type 2 polio outbreaks.
Field site: The study will be carried out in urban slums in Mirpur and Mohakahli in Dhaka.
- Conditions
- Poliomyelitis
- Being tested
- mOPV2 at 6 and 7 weeks of age, mOPV2 at 6 and 8 weeks of age, mOPV2 at 6 and 10 weeks of age, IPV at 6 weeks of age
- Keywords
- Polio, Inactivated polio vaccine, oral polio vaccine, monovalent type 2 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.
mOPV2 at 6 and 7 weeks of ageBiological
Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 7 weeks of age
mOPV2 at 6 and 8 weeks of ageBiological
Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 8 weeks of age
mOPV2 at 6 and 10 weeks of ageBiological
Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 10 weeks of age
IPV at 6 weeks of ageBiological
Participants assigned to this intervention will receive a dose of inactivated polio vaccine (IPV) 6 weeks of age
| Study group | Role | What they receive |
|---|---|---|
| mOPV2 at 6 and 7 weeks of age | Active comparator | Participants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 7 weeks of age Receives: Biological: mOPV2 at 6 and 7 weeks of age |
| mOPV2 at 6 and 8 weeks of age | Active comparator | Participants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 8 weeks of age Receives: Biological: mOPV2 at 6 and 8 weeks of age |
| mOPV2 at 6 and 10 weeks of age | Active comparator | Participants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 10 weeks of age Receives: Biological: mOPV2 at 6 and 10 weeks of age |
| mOPV2 at 6 and 10 week of age and IPV at 6 weeks of age | Active comparator | Participants enrolled in this arm would receive a dose monovalent type 2 oral polio vaccine (mOPV2) at 6 and 10 weeks of age. In addition, the participants will also receive inactivated polio vaccine (IPV) at 6 weeks of age Receives: Biological: mOPV2 at 6 and 10 weeks of age; Biological: IPV at 6 weeks of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of type 2 immunogenicity
To assess type 2 immunogenicity seroconversion will be determined in each study arm. Seroconversion will be defined as either a four-fold increase from the titer predicted after accounting for the expected decline in maternal antibodies, assuming a half-life of 28 days, or a seronegative participant (<1:8 titers) who becomes seropositive (≥1:8). The antibody titers at 6 weeks of age will be assumed to be the starting point for the expected decline in maternal antibody. The endpoint titer assessment will be 4 weeks after completing study vaccination schedule.
Measured: The antibody titers 4 weeks after completing the vaccination schedule compared to that at 6 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 posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 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
- 760 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
- NCT02643368
- Sponsor's protocol ID
- ICDDRB-RRC-PR-15085
- Status last verified
- Mar 2016
- First submitted
- 10 Dec 2015
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zaman K, Estivariz CF, Morales M, Yunus M, Snider CJ, Gary HE Jr, Weldon WC, Oberste MS, Wassilak SG, Pallansch MA, Anand A. Immunogenicity of type 2 monovalent oral and inactivated poliovirus vaccines for type 2 poliovirus outbreak response: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Jun;18(6):657-665. doi: 10.1016/S1473-3099(18)30113-0. Epub 2018 Mar 20.
PubMed 29571817
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Immunogenicity of Type 2 Monovalent Oral Poliovirus Vaccine Administered at One, Two or Four Week Intervals and When Coadministered With Inactivated Poliovirus Vaccine in an Urban Area in Bangladesh
- ClinicalTrials.gov ID
- NCT02643368
- Acronym / sponsor ID
- ICDDRB-RRC-PR-15085
- Conditions
- Poliomyelitis
- Keywords
- Polio, Inactivated polio vaccine, oral polio vaccine, monovalent type 2 oral polio vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 31 Dec 2015 (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 is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the first dose of mOPV2, in a two dose schedule with a four week interval, is administered simultaneously with IPV.
Detailed description
The Strategic Advisory Group of Experts on Immunization (SAGE) has recommended a phased cessation of OPVs starting with serotype 2 (OPV2). This is because the last case of type 2 wild poliovirus (WPV2) was reported in 1999 and type 2 vaccine poliovirus is associated with the highest risk of causing paralysis due to reversion to vaccine derived poliovirus (VDPV), in which the reverted virus acquires not only the ability to cause paralysis but also the ability to transmit from person-to-person. Withdrawal of OPV2 will be done through the replacement worldwide of trivalent OPV (tOPV) with bivalent (types 1 and 3) OPV (bOPV) for use in routine immunization and in campaigns.
After the tOPV to bOPV switch, there will be strict biosafety requirements for the use of vaccines containing OPV2. Trivalent OPV will no longer exist and use of monovalent OPV2 (mOPV2) will be limited to responding to a type 2 outbreak. To respond to poliovirus type 2 outbreaks, the Global Polio Eradication Initiative has proposed delivering using mOPV2 in campaigns conducted in the primary zone of the outbreak and IPV in campaigns conducted in areas adjacent to outbreak zone. Therefore, mOPV2 will be a critical component of response to poliovirus type 2 outbreaks.
Typically, polio campaigns are conducted at an interval of 4 weeks. Recently, a clinical trial conducted by icddr,b and the U.S. Centers for Disease Control and Prevention (CDC) in Matlab and Mirpur in Bangladesh demonstrated non-inferiority of type 1 seroconversion after bOPV or mOPV1 at a 2 week interval compared to 4 weeks between doses. Based these findings, the Global Polio Eradication Initiative (GPEI) concluded that the immune response to "OPV is satisfactory when the interval between doses is shortened to 14 or even 7 days (in case of mOPV1)" and has used short-interval campaigns to deliver mOPV1 and bOPV in areas with security-limited access and for outbreak response. However, there are no data and no current or planned polio clinical trials are assessing the impact on immunogenicity of mOPV2 of a reduction in the interval between mOPV2 doses or of administration of mOPV2 in combination with IPV. Therefore, the findings from the trial proposed in this protocol have a direct and immediate implication on strategies to respond to type 2 polio outbreaks.
Field site: The study will be carried out in urban slums in Mirpur and Mohakahli in Dhaka.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mOPV2 at 6 and 7 weeks of age | Active comparator | Biological: mOPV2 at 6 and 7 weeks of ageParticipants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 7 weeks of age |
| mOPV2 at 6 and 8 weeks of age | Active comparator | Biological: mOPV2 at 6 and 8 weeks of ageParticipants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 8 weeks of age |
| mOPV2 at 6 and 10 weeks of age | Active comparator | Biological: mOPV2 at 6 and 10 weeks of ageParticipants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 10 weeks of age |
| mOPV2 at 6 and 10 week of age and IPV at 6 weeks of age | Active comparator | Biological: mOPV2 at 6 and 10 weeks of age, Biological: IPV at 6 weeks of ageParticipants enrolled in this arm would receive a dose monovalent type 2 oral polio vaccine (mOPV2) at 6 and 10 weeks of age. In addition, the participants will also receive inactivated polio vaccine (IPV) at 6 weeks of age |
Who may qualify
- Ages
- 6 to 7 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
- Evidence of a chronic medical condition identified during physical exam.
- 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 diarrhea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV or IPV per country guidelines.
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 |
|---|---|---|
| mOPV2 at 6 and 7 weeks of ageParticipants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 7 weeks of age | Biological | mOPV2 at 6 and 7 weeks of age |
| mOPV2 at 6 and 8 weeks of ageParticipants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 8 weeks of age | Biological | mOPV2 at 6 and 8 weeks of age |
| mOPV2 at 6 and 10 weeks of ageParticipants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 10 weeks of age | Biological | mOPV2 at 6 and 10 week of age and IPV at 6 weeks of age, mOPV2 at 6 and 10 weeks of age |
| IPV at 6 weeks of ageParticipants assigned to this intervention will receive a dose of inactivated polio vaccine (IPV) 6 weeks of age | Biological | mOPV2 at 6 and 10 week of age and IPV at 6 weeks of age |
Primary outcome
Assessment of type 2 immunogenicity
Time frame: The antibody titers 4 weeks after completing the vaccination schedule compared to that at 6 weeks of age.
To assess type 2 immunogenicity seroconversion will be determined in each study arm. Seroconversion will be defined as either a four-fold increase from the titer predicted after accounting for the expected decline in maternal antibodies, assuming a half-life of 28 days, or a seronegative participant (<1:8 titers) who becomes seropositive (≥1:8). The antibody titers at 6 weeks of age will be assumed to be the starting point for the expected decline in maternal antibody. The endpoint titer assessment will be 4 weeks after completing study vaccination schedule.
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 Jan 2018.
- Derived from this study: PubMed 29571817Zaman K, Estivariz CF, Morales M, Yunus M, Snider CJ, Gary HE Jr, Weldon WC, Oberste MS, Wassilak SG, Pallansch MA, Anand A. Immunogenicity of type 2 monovalent oral and inactivated poliovirus vaccines for type 2 poliovirus outbreak response: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Jun;18(6):657-665. doi: 10.1016/S1473-3099(18)30113-0. Epub 2018 Mar 20.
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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.
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 mOPV2 at 6 and 7 weeks of age, mOPV2 at 6 and 8 weeks of age and mOPV2 at 6 and 10 weeks of age in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site 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 Jan 2018. 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 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?
Assessment of type 2 immunogenicity (time frame: The antibody titers 4 weeks after completing the vaccination schedule compared to that at 6 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 NCT02643368, 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 25 Jan 2018.