Oral Polio Vaccine Clinical Trial
Official title:
Comparison of mOPV1 Schedules for Routine Immunization in Pakistan. A Community Based Randomized Control Trial
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.
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 1,2 and 3 polioviruses achieved with two
different mOPV1 routine immunization schedule (mOPV1+fIPV (fractional dose intradermal
IPV); mOPV1+FIPV (full dose intramuscular IPV))
- To compare the serum immunity against type 1,2 and 3 polioviruses achieved with two
different mOPV1 routine immunization schedule with bOPV2 routine immunization schedules
(mOPV1+fIPV, mOPV1+FIPV with bOPV2+fIPV, bOPV2+FIPV)
- 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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03460002 -
Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children
|
Phase 4 |