Use of mOPV1 in Routine Immunization in Pakistan.

NCT04504539 | Unknown

• 1 other identifier: 2020-3284-11191
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Polio Vaccine

Keywords

mOPV; bOPV; randomized trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

mOPV with FIPV

EXPERIMENTAL

mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age.

Biological: mOPV; Biological: Full dose IPV; Biological: fractional IPV

bOPV with FIPV

EXPERIMENTAL

bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age.

Biological: bOPV; Biological: Full dose IPV; Biological: fractional IPV

mOPV with fIPV

EXPERIMENTAL

mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age.

Biological: mOPV; Biological: Full dose IPV; Biological: fractional IPV

bOPV with fIPV

EXPERIMENTAL

bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age.

Biological: bOPV; Biological: Full dose IPV; Biological: fractional IPV

Interventions

mOPV BIOLOGICAL

mOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1

mOPV with FIPV; mOPV with fIPV

bOPV BIOLOGICAL

bOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3

bOPV with FIPV; bOPV with fIPV

Full dose IPV BIOLOGICAL

FIPV (full dose injectable polio vaccine)

bOPV with FIPV; bOPV with fIPV; mOPV with FIPV; mOPV with fIPV

fractional IPV BIOLOGICAL

fIPV (fractional dose injectable polio vaccine)

bOPV with FIPV; bOPV with fIPV; mOPV with FIPV; mOPV with fIPV

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• World Health Organization: collaborator

Study Sites (1)

Aga Khan University

Karachi, 74800, Pakistan

Location

Study Officials

• Ali Saleem

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Saleem

CONTACT

02134930051; ali.saleem@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The mOPV and bOPV vaccine vials will be masked by the Clinical Trials Unit to look identical. The assessor will only be provided the enrollment ID and will not be aware of the participant's randomization status.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Different regimens of mOPV and bOPV in combination with either fractional IPV (fIPV) or full dose IPV (FIPV) will be used.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)