Use of mOPV1 in Routine Immunization in Pakistan.

Oral Polio Vaccine Clinical Trial

— mOPV1  

Official title:

Comparison of mOPV1 Schedules for Routine Immunization in Pakistan. A Community Based Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04504539
• Other study ID #: 2020-3284-11191
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Aga Khan University
• Contact: Ali Saleem
• Phone: 02134930051
• Email: ali.saleem[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: December 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• born healthy with birth weight 2.0 kg or more, with immediate cry.

• Parents resident of the study areas Not planning to travel away during entire the study period (birth-154 days; birth - 22 weeks) for 3 months at the time of enrolment

• Parent/guardian provides informed consent

Exclusion Criteria:

• Refusal of blood testing and cord blood testing

• Receipt of OPV after birth before eligibility screen

• Newborns with certain medical conditions i.e., syndromic infants, neonate with petechial or purpura (contraindication of intramuscular injections)

• A confirmed diagnosis of immunodeficiency disorder in a blood relative will render the newborn ineligible for the study.

Related Conditions & MeSH terms

• Oral Polio Vaccine

Intervention

Biological:
• mOPV
mOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1
• bOPV
bOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3
• Full dose IPV
FIPV (full dose injectable polio vaccine)
• fractional IPV
fIPV (fractional dose injectable polio vaccine)

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	World Health Organization

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children with change in antibody titres following vaccination	The number of children who produce antibodies following vaccination of each of the 4 arms	This will be checked in samples taken at birth, 6 weeks post vaccination, 10 weeks, 14 weeks and 18 weeks of age