Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504539
Status:
UNKNOWN
Last Update Posted:
2020-08-07
First Post:
2020-07-23
Brief Title:
Use of mOPV1 in Routine Immunization in Pakistan
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Comparison of mOPV1 Schedules for Routine Immunization in Pakistan A Community Based Randomized Control Trial
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mOPV1
Brief Summary:
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community Bivalent OPV bOPV which protects against types 1 and 3 is used for routine immunization However type-3 wild poliovirus is on the verge of eradication therefore mOPV1 is important to achieve eradication of type-1 poliovirus
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization which contains live poliovirus and will eventually lead to complete eradication and containment of type 1 WPV vaccine-related VDPV and Sabin polioviruses This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization which contains live poliovirus and will eventually lead to complete eradication and containment of type 1 WPV vaccine-related VDPV and Sabin polioviruses This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks
Detailed Description:
Wild Polio Virus 1 WPV1 is the only responsible virus for wild polio cases across the globe The world has successfully eradicated wild poliovirus PV 2 and 3 Poliomyelitis eradication has entered its last phase with only three remaining endemic countries of which Pakistan is one and has highest number of WPV1 cases in 2019 The main stream strategies by the Global Polio Eradication Initiative has made the substantial progress towards the eradication of poliomyelitis ever since the World Health Assembly has sanctioned it as an emerging global Public Health threat These strategies focus on high-quality immunization activities routine and supplemental that target children from birth to age 5 years with oral poliovirus vaccines OPVs and maintaining a system for acute flaccid paralysis surveillance
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community and implies impending failure of goal of global eradication According to the Polio endgame strategy 2019-2023 Pakistan and Afghanistan are the only countries in which WPV transmissions continues to be reported The genetic sampling and environmental surveillance have revealed that WPV1 has predominantly persisted in Pakistan and Afghanistan and are closely linked as they constitute one epidemiological block Bivalent OPV bOPV which protect against types 1 and 3 is used for routine immunization However type-3 wild poliovirus is on the verge of eradication therefore mOPV1 is important to achieve eradication of type-1 poliovirus whose appearance has been continually been confirmed by the genetic and environmental samplings
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization which contains live poliovirus and will eventually lead to complete eradication and containment of type 1 WPV vaccine-related VDPV and Sabin polioviruses The study rationale is in line with the Goal 1- Eradication of GPEI This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks
Research Questions and Main Objectives
Overall Objectives of the study will be
To assess the serum immunity against type 12 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule mOPV1fIPV fractional dose intradermal IPV mOPV1FIPV full dose intramuscular IPV
To compare the serum immunity against type 12 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule with bOPV2 routine immunization schedules mOPV1fIPV mOPV1FIPV with bOPV2fIPV bOPV2FIPV
To assess the type 2 response after One full dose IPV with mOPV1 and bOPV2 routine immunization schedule
To assess the type 2 response after two fractional doses of IPV with mOPV1 and bOPV2 routine immunization schedule
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community and implies impending failure of goal of global eradication According to the Polio endgame strategy 2019-2023 Pakistan and Afghanistan are the only countries in which WPV transmissions continues to be reported The genetic sampling and environmental surveillance have revealed that WPV1 has predominantly persisted in Pakistan and Afghanistan and are closely linked as they constitute one epidemiological block Bivalent OPV bOPV which protect against types 1 and 3 is used for routine immunization However type-3 wild poliovirus is on the verge of eradication therefore mOPV1 is important to achieve eradication of type-1 poliovirus whose appearance has been continually been confirmed by the genetic and environmental samplings
The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization which contains live poliovirus and will eventually lead to complete eradication and containment of type 1 WPV vaccine-related VDPV and Sabin polioviruses The study rationale is in line with the Goal 1- Eradication of GPEI This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks
Research Questions and Main Objectives
Overall Objectives of the study will be
To assess the serum immunity against type 12 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule mOPV1fIPV fractional dose intradermal IPV mOPV1FIPV full dose intramuscular IPV
To compare the serum immunity against type 12 and 3 polioviruses achieved with two different mOPV1 routine immunization schedule with bOPV2 routine immunization schedules mOPV1fIPV mOPV1FIPV with bOPV2fIPV bOPV2FIPV
To assess the type 2 response after One full dose IPV with mOPV1 and bOPV2 routine immunization schedule
To assess the type 2 response after two fractional doses of IPV with mOPV1 and bOPV2 routine immunization schedule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None