Vaccine Virus SheddingPhase 3NCT02477046
Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh
A Phase 3 study testing tOPV, bOPV and IPV in people with Vaccine Virus Shedding, run by University of Virginia at 1 site in Bangladesh.
Trial summary
The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine (IPV) in routine immunization globally, to be instituted in 2015-2016. Read more about this study
- Who is it for?
- Ages 42 to 48 daysHealthy volunteers can take part
- Conditions the study is for
- Vaccine Virus Shedding
- What is being tested?
- tOPV, bOPV and IPV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- 1 siteBangladesh
- Study dates
- Apr 2015to Jun 2017
- Phase
- Phase 3
- 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 42 to 48 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female infant at least 6 weeks of age (42-48 days) at the time of enrollment
- For the Special Immunization Activity (SIA) only, being age 5 years or younger at the time of the SIA
- An infant whose parent or guardian's primary residence, at the time of first Expanded Program on Immunization (EPI) vaccinations, is a village selected to receive polio vaccine.
- Written informed consent obtained from the parent or guardian of the participant, prior to the participants's first study vaccination
Who cannot join
- History of prior polio vaccination (in the 810 infants enrolled at 6 weeks of age only)
- Hypersensitivity to the active substance or any component in the vaccine
- Subjects with uncorrected congenital malformation
- Infants with known or suspected immunodeficiency
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Matlab
About this study
The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine (IPV) in routine immunization globally, to be instituted in 2015-2016. At the community level, the impact of the change from tOPV + IPV to bOPV + IPV on Sabin virus fecal-oral transmission (duration of circulation, degree of genetic reversion) and the persistence of environmental contamination are unknown. Also unknown is the impact of the change from tOPV to bOPV on community circulation of Sabin 2 after a special immunization (SI) activity with monovalent oral poliovirus type 2 (mOPV2). Finally it is unknown at the level of an individual child if type 2 fecal shedding will be limited by cross-protection from oral vaccination with Sabin type 1 and 3.
The investigators propose to measure at a community level transmission of Sabin 2 virus in Bangladesh, a low income country, where fecal-oral transmission and environmental exposures are high, comparing transmission in the setting of vaccination with tOPV+IPV vs. bOPV+IPV. The study will be conducted in 67 villages in Matlab, Bangladesh, using a cluster-randomized study design. Villages in Matlab will be randomly assigned to receive as part of routine immunization (RI) activities: (1) tOPV (6,10,14 weeks) plus IPV at 14 weeks; (2) bOPV (6,10, 14 weeks) plus IPV at 14 weeks; or (3) bOPV (6,10, 14 weeks) plus IPV at 14 and 18 weeks. Community and environmental surveillance for Sabin 2 virus will be conducted in each village over the 9 month period of these RI activities. In addition, a SI activity with mOPV2 will occur 9 months into the study to model an outbreak response. For the 6 months following the mOPV2 challenge, the impact of the different vaccination regimens on Sabin 2 transmission in the community will be determined, as well as individual level protection (as measured by fecal shedding from days 7-70 after mOPV2 challenge).
- Conditions
- Vaccine Virus Shedding
- Being tested
- tOPV, bOPV, IPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tOPVBiological
administered per protocol
bOPVBiological
administered per protocol
IPVBiological
administered per protocol
| Study group | Role | What they receive |
|---|---|---|
| tOPV + IPV | Experimental | tOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive tOPV plus IPV boost Receives: Biological: tOPV; Biological: IPV |
| bOPV + IPV | Experimental | bOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive bOPV plus 1 IPV boost Receives: Biological: bOPV; Biological: IPV |
| bOPV + 2 IPV | Experimental | bOPV (6, 10, and 14 weeks) + IPV (14 and 18 weeks) Randomized to receive bOPV plus 2 IPV boost Receives: Biological: bOPV; Biological: IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal shedding of type 2 Sabin virus by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 60% of infants that did not receive the mOPV2 challenge
The transmission rate of type 2 Sabin virus in the 60% of the enrolled infants that did not receive the mOPV2 challenge between Arm A vs Arm B, Arm A vs Arm C, and Arm B and Arm C.
Measured: 10 weeks following mOPV2 challenge at month 9 of the study
Secondary outcomes (1)
fecal shedding of type 2 Sabin virus by RT-qPCR in 40% of infants that received the mOPV2 challenge
Individual protection to type 2 poliovirus from different vaccination schedules
Measured: 10 weeks following mOPV2 challenge at month 9 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaccine Virus SheddingStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Mami Taniuchi, PhD, University of Virginia
- Investigators
- William A Petri, Jr., MD, PhD, Principal investigator, University of VirginiaMami Taniuchi, PhD, Principal investigator, University of VirginiaK Zaman, MBBS, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477046
- Sponsor's protocol ID
- 00000447
- Other IDs
- PR-15004
- Status last verified
- Oct 2016
- First submitted
- 18 Jun 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taniuchi M, Begum S, Uddin MJ, Platts-Mills JA, Liu J, Kirkpatrick BD, Chowdhury AH, Jamil KM, Haque R, Petri WA Jr, Houpt ER. Kinetics of poliovirus shedding following oral vaccination as measured by quantitative reverse transcription-PCR versus culture. J Clin Microbiol. 2015 Jan;53(1):206-11. doi: 10.1128/JCM.02406-14. Epub 2014 Nov 5.
PubMed 25378579Famulare M, Wong W, Haque R, Platts-Mills JA, Saha P, Aziz AB, Ahmed T, Islam MO, Uddin MJ, Bandyopadhyay AS, Yunus M, Zaman K, Taniuchi M. Multiscale model for forecasting Sabin 2 vaccine virus household and community transmission. PLoS Comput Biol. 2021 Dec 21;17(12):e1009690. doi: 10.1371/journal.pcbi.1009690. eCollection 2021 Dec.
PubMed 34932560Taniuchi M, Famulare M, Zaman K, Uddin MJ, Upfill-Brown AM, Ahmed T, Saha P, Haque R, Bandyopadhyay AS, Modlin JF, Platts-Mills JA, Houpt ER, Yunus M, Petri WA Jr. Community transmission of type 2 poliovirus after cessation of trivalent oral polio vaccine in Bangladesh: an open-label cluster-randomised trial and modelling study. Lancet Infect Dis. 2017 Oct;17(10):1069-1079. doi: 10.1016/S1473-3099(17)30358-4. Epub 2017 Jul 7.
PubMed 28693854
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh
- ClinicalTrials.gov ID
- NCT02477046
- Acronym / sponsor ID
- 00000447
- Conditions
- Vaccine Virus Shedding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Jun 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.
The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine (IPV) in routine immunization globally, to be instituted in 2015-2016. At the community level, the impact of the change from tOPV + IPV to bOPV + IPV on Sabin virus fecal-oral transmission (duration of circulation, degree of genetic reversion) and the persistence of environmental contamination are unknown. Also unknown is the impact of the change from tOPV to bOPV on community circulation of Sabin 2 after a special immunization (SI) activity with monovalent oral poliovirus type 2 (mOPV2). Finally it is unknown at the level of an individual child if type 2 fecal shedding will be limited by cross-protection from oral vaccination with Sabin type 1 and 3.
The investigators propose to measure at a community level transmission of Sabin 2 virus in Bangladesh, a low income country, where fecal-oral transmission and environmental exposures are high, comparing transmission in the setting of vaccination with tOPV+IPV vs. bOPV+IPV. The study will be conducted in 67 villages in Matlab, Bangladesh, using a cluster-randomized study design. Villages in Matlab will be randomly assigned to receive as part of routine immunization (RI) activities: (1) tOPV (6,10,14 weeks) plus IPV at 14 weeks; (2) bOPV (6,10, 14 weeks) plus IPV at 14 weeks; or (3) bOPV (6,10, 14 weeks) plus IPV at 14 and 18 weeks. Community and environmental surveillance for Sabin 2 virus will be conducted in each village over the 9 month period of these RI activities. In addition, a SI activity with mOPV2 will occur 9 months into the study to model an outbreak response. For the 6 months following the mOPV2 challenge, the impact of the different vaccination regimens on Sabin 2 transmission in the community will be determined, as well as individual level protection (as measured by fecal shedding from days 7-70 after mOPV2 challenge).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tOPV + IPV | Experimental | Biological: tOPV, Biological: IPVtOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive tOPV plus IPV boost |
| bOPV + IPV | Experimental | Biological: bOPV, Biological: IPVbOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive bOPV plus 1 IPV boost |
| bOPV + 2 IPV | Experimental | Biological: bOPV, Biological: IPVbOPV (6, 10, and 14 weeks) + IPV (14 and 18 weeks) Randomized to receive bOPV plus 2 IPV boost |
Who may qualify
- Ages
- 42 to 48 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A male or female infant at least 6 weeks of age (42-48 days) at the time of enrollment
- For the Special Immunization Activity (SIA) only, being age 5 years or younger at the time of the SIA
- An infant whose parent or guardian's primary residence, at the time of first Expanded Program on Immunization (EPI) vaccinations, is a village selected to receive polio vaccine.
- Written informed consent obtained from the parent or guardian of the participant, prior to the participants's first study vaccination
Key exclusion criteria (4 listed)
- History of prior polio vaccination (in the 810 infants enrolled at 6 weeks of age only)
- Hypersensitivity to the active substance or any component in the vaccine
- Subjects with uncorrected congenital malformation
- Infants with known or suspected immunodeficiency
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 |
|---|---|---|
| tOPVadministered per protocol | Biological | tOPV + IPV |
| bOPVadministered per protocol | Biological | bOPV + 2 IPV, bOPV + IPV |
| IPVadministered per protocol | Biological | bOPV + 2 IPV, bOPV + IPV, tOPV + IPV |
Primary outcome
fecal shedding of type 2 Sabin virus by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 60% of infants that did not receive the mOPV2 challenge
Time frame: 10 weeks following mOPV2 challenge at month 9 of the study
The transmission rate of type 2 Sabin virus in the 60% of the enrolled infants that did not receive the mOPV2 challenge between Arm A vs Arm B, Arm A vs Arm C, and Arm B and Arm C.
1 secondary outcome
fecal shedding of type 2 Sabin virus by RT-qPCR in 40% of infants that received the mOPV2 challenge
Time frame: 10 weeks following mOPV2 challenge at month 9 of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 25378579Taniuchi M, Begum S, Uddin MJ, Platts-Mills JA, Liu J, Kirkpatrick BD, Chowdhury AH, Jamil KM, Haque R, Petri WA Jr, Houpt ER. Kinetics of poliovirus shedding following oral vaccination as measured by quantitative reverse transcription-PCR versus culture. J Clin Microbiol. 2015 Jan;53(1):206-11. doi: 10.1128/JCM.02406-14. Epub 2014 Nov 5.
- Derived from this study: PubMed 34932560Famulare M, Wong W, Haque R, Platts-Mills JA, Saha P, Aziz AB, Ahmed T, Islam MO, Uddin MJ, Bandyopadhyay AS, Yunus M, Zaman K, Taniuchi M. Multiscale model for forecasting Sabin 2 vaccine virus household and community transmission. PLoS Comput Biol. 2021 Dec 21;17(12):e1009690. doi: 10.1371/journal.pcbi.1009690. eCollection 2021 Dec.
- Derived from this study: PubMed 28693854Taniuchi M, Famulare M, Zaman K, Uddin MJ, Upfill-Brown AM, Ahmed T, Saha P, Haque R, Bandyopadhyay AS, Modlin JF, Platts-Mills JA, Houpt ER, Yunus M, Petri WA Jr. Community transmission of type 2 poliovirus after cessation of trivalent oral polio vaccine in Bangladesh: an open-label cluster-randomised trial and modelling study. Lancet Infect Dis. 2017 Oct;17(10):1069-1079. doi: 10.1016/S1473-3099(17)30358-4. Epub 2017 Jul 7.
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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.
William A Petri, Jr., MD, PhD principal investigator
University of Virginia
Mami Taniuchi, PhD principal investigator
University of Virginia
K Zaman, MBBS, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tOPV, bOPV and IPV in people with Vaccine Virus Shedding, run by University of Virginia 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 4 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 26 Oct 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
fecal shedding of type 2 Sabin virus by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 60% of infants that did not receive the mOPV2 challenge (time frame: 10 weeks following mOPV2 challenge at month 9 of the study). 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 NCT02477046, which also lists 3 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 26 Oct 2016.