Pakistan Short Interval mOPV1 Compared With Standard Interval mOPV1 and bOPV 1,3 (SIAD)

June 26, 2015 updated by: Anita Kaniz Mehdi Zaidi, Aga Khan University

Comparison of Immunogenicity of Type 1 mOPV Administered at Short Intervals With Type 1 mOPV1 and Type 1 & 3 bOPV Oral Polio Vaccine Given at Standard Intervals in Pakistan:A Randomized Trial

Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in tribal areas present special challenges in interrupting transmission rapidly. There exists limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity levels in young children. The aim of this study is to demonstrate the non-inferiority of shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals beginning at 6 weeks of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial which will be conducted in 5 low-income areas in and around Karachi (4 peri-urban, contiguous coastal villages outside Karachi, and one urban squatter settlement) where the Aga Khan University's Department of Paediatrics and Child Health has well-established demographic surveillance with all pregnancies and new births in the area captured through the system. The study participants will be enrolled from birth until 102 days. Subjects will be randomized to one of four trial arms.

All children will receive tOPV at birth. At 42 days (6 weeks) of age, three study arms will receive a dose of mOPV1 whereas the fourth arm will receive a dose of bOPV1&3 as per protocol. Then 7 or 14 or 30 days later, the study participants in Arms A, B, and C will receive a second dose of mOPV1 while a second dose of bOPV 1&3 will be given to participants in Arm D at 30 days.

Name and description of products:

  1. Standard trivalent oral poliovirus vaccine (tOPV), in a 10:1:6 formulation, containing at least 106 TCID50 of Sabin -strain poliovirus type 1, at least 105 TCID50 of Sabin-strain poliovirus type 2 and at least 105.8 TCID50 of Sabin-strain poliovirus type 3.
  2. Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
  3. The bivalent oral polio vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3.

Sample Size:

To show non-inferiority of a 2-dose mOPV1 schedule with shorter-intervals (either 7 or 14 days) [intervention] compared to a 2-dose mOPV1 schedule administered at 30-day intervals [control], and a 2-dose bOPV13 schedule administered at a 30-day interval (control) assuming a power of 0.90 (beta) and p of 0.05 (alpha), we require a sample of 139 for each study group, for a total of 556 subjects. To compensate for drop out, attrition and insufficient sera for laboratory testing, an inflated (by ~ 50%) sample size of 200 in each group will be used (total sample size of 800)

Efficacy Endpoints:

The primary endpoint is seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1&3 given at the standard interval of 30 days..

The secondary endpoint is seroconversion following the birth dose of tOPV.

All samples will be processed at the Centers of Disease Control and Prevention CDC) Laboratories (a Global Specialized Polio Network Laboratory).

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan, 74800
        • Aga Khan University
    • Sindh
      • Karachi, Sindh, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants > 2.5 kg birth weight
  • Immediate cry
  • No neonatal IMCI danger signs
  • Not planning to travel away during entire the study period (birth-102 days)

Exclusion Criteria:

  • High-risk newborns will be excluded, as well as newborns requiring hospitalization
  • Birth weight below 2.5 kg
  • Cry >2 minutes
  • With any neonatal IMNCI danger signs
  • Residence >30 km from study site
  • Family is planning to be absent during the birth - 102 day study period.
  • A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mOPV1- Arm A
Arm A will be administered a second dose of mOPV1 seven days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at day 79.
Drug: mOPV1
Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
Other Names:
  • Monovalent type 1 oral poliovirus vaccine
Experimental: mOPV1- Arm B
Arm B will be administered a second dose of mOPV1 fourteen days after after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 86 days.
Drug: mOPV1
Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
Other Names:
  • Monovalent type 1 oral poliovirus vaccine
Experimental: mOPV1-Arm C
Arm C will receive the second dose of mOPV1 thirty days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 102 days.
Drug: mOPV1
Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
Other Names:
  • Monovalent type 1 oral poliovirus vaccine
Experimental: Arm D- bOPV1,3
Arm D will be administered a second dose of bOPV1,3 thirty days after the 42 day bOPV1,3 index dose.Second dose of tOPV2 will be given at day 102.
Drug: bOPV 1,3
The bivalent vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3.
Other Names:
  • Bivalent Oral Polio Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1&3 given at the standard interval of 30 days.
Time Frame: Participants will be followed till 102 days after birth
Humoral immunity: Sera collected at birth (cord blood or peripheral blood), at 42 days, at 79 days, at 86 days, or at 102 days (depending on study arm) will be examined for the presence (detectable) or absence of neutralizing antibodies to all three poliovirus serotypes. A reciprocal titer of >8 is considered to indicate the presence of neutralizing antibodies. For participants with detectable antibodies, seroconversion is defined as a 4-fold increase over the expected decline of maternally-derived antibodies (half-life assumed to be 28 days).
Participants will be followed till 102 days after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Seroconversion following the birth dose of tOPV.
Time Frame: At birth
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

World Health Organization

Investigators

  • Principal Investigator: Anita KM Zaidi, MD; MSc, Aga Khan University
  • Study Director: Fatima FM Mir, MBBS, The Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1891-Ped-ERC-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polio

Clinical Trials on mOPV1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe