NCT02477046

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
810

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

June 18, 2015

Last Update Submit

October 24, 2016

Conditions

Vaccine Virus Shedding

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    10 weeks following mOPV2 challenge at month 9 of the study

Study Arms (3)

tOPV + IPV

EXPERIMENTAL

tOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive tOPV plus IPV boost

Biological: tOPVBiological: IPV

bOPV + IPV

EXPERIMENTAL

bOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive bOPV plus 1 IPV boost

Biological: bOPVBiological: IPV

bOPV + 2 IPV

EXPERIMENTAL

bOPV (6, 10, and 14 weeks) + IPV (14 and 18 weeks) Randomized to receive bOPV plus 2 IPV boost

Biological: bOPVBiological: IPV

Interventions

tOPVBIOLOGICAL

administered per protocol

tOPV + IPV
bOPVBIOLOGICAL

administered per protocol

bOPV + 2 IPVbOPV + IPV
IPVBIOLOGICAL

administered per protocol

bOPV + 2 IPVbOPV + IPVtOPV + IPV

Eligibility Criteria

Age42 Days - 48 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Matlab, Bangladesh

Location

Related Publications (3)

  • 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.

    PMID: 25378579BACKGROUND

  • Famulare 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.

    PMID: 34932560DERIVED

  • Taniuchi 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.

    PMID: 28693854DERIVED

Study Officials

  • William A Petri, Jr., MD, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

  • Mami Taniuchi, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

  • K Zaman, MBBS, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Research

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 22, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

June 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

BA(1)