Comparison of Immunogenicity of Inactivated Poliovirus Vaccine (IPV) Administered Intramuscularly or Intradermally

January 30, 2024 updated by: Instituto Nacional de Saúde, Mozambique

Clinical Trial to Compare the Immunogenicity of the Inactivated Poliovirus Vaccine (IPV) Administered in Reduced Doses Intramuscularly or Intradermally in Infants at 2 and 4 Months of Age in the Maputo City

Polio is an acute transmissible disease caused by any of the three polio virus serotypes (types 1, 2 or 3). In Mozambique, polio vaccination is part of the immunization schedule of the expanded vaccination program. The oral vaccine (OPV) is administered at months 0,2,3, and 4 and a single dose of the inactivated poliovirus vaccine (IPV) is given intramuscularly at month 4. In 2016 shortage of IPV supply caused stock-outs and put strain on IPV use for routine immunizations as well as for poliovirus outbreak response. Therefore, assessment of new vaccine regimens using smaller doses of IPV are needed. Administration of fractionated IPV (fIPV), i.e., 1/5 (0.1mL) of the standard dose, intradermally has shown to be safe and to provide an immune response similar to the standard dose of IPV that is currently given intramuscularly. However, intradermal administration of fIPV is technically difficult and many countries are hesitant to adopt fIPV in their routine immunization schedules. Therefore, the investigators need data confirming that the use of the fIPV vaccine intramuscularly is safe and the immune response is not inferior to the use of fIPV intradermally. Study Objective: to compare the immunogenicity of fIPV administered intramuscularly or intradermally in infants at 2 and 4 months of age. Study Hypotheses: the seroconversion rate after administration of one or two doses of fIPV intramuscularly is not inferior to the fIPV intradermally. The priming effect after fIPV administered intramuscularly is not inferior to the fIPV intradermally. Study Methods: This will be a phase II non-inferiority clinical trial. 360 children will be enrolled in two study groups, with prior consent of the parents / guardians. In group I, 180 children will receive 0.1 ml of IPV intramuscularly and in group II 180 children will receive the same dose intradermally. There will not be a group control. The children will be selected at birth at pre-defined health units in Maputo city. The fractional IPV vaccine will be given to children at 2 and 4 months of age during routine vaccinations. In total there will be four study visits, of which the first two are vaccination visits. All visits will be performed at the health units. 1 ml of blood will be collected at each study visit to assess the immune response before and after vaccination. Data will be collected by trained and qualified personnel and in accordance with Good Clinical Practice standards. Adverse events following administration of the vaccine will be monitored and all serious adverse events will be reported to ethics and regulatory committees, and to World Health Organization (WHO). Evaluation of the immune response: Seroconversion rates and priming effect will be evaluated. Serum will be tested for the presence of neutralizing antibodies against poliovirus using standard neutralization assays and immunogenicity will be assessed by titration of anti-polio 2 immunoglobulin G.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Phase 2

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

  • Mozambique
      • Maputo, Mozambique, 21-462867
        • Instituto Nacional de Saúde-Mozambique CISPOC
      • Maputo, Mozambique
        • INSMozambique

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

2 months to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children whose parents/guardians consent to their participation;
  • Children whose parents/guardians live in the study area and do not intend to depart during the study period.

Exclusion Criteria:

  • Children whose parents are under the legal age with exception of 16-years-old parents who are already living in marital status;
  • Children whose parents have mental illness;
  • Children with immunosuppression.

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
Active Comparator: fIPV Intramuscular
180 children will receive 0,1 ml of inactivated poliovirus vaccine intramuscularly
Biological: Inactivated poliovirus vaccine in reduced doses

contains the following excipients: 2-phenoxyethanol (2.5 mg), water for injection and diluent solution and phosphate buffer having the following composition: sodium phosphate, sodium chloride, potassium chloride, magnesium sulfate, phenol red and calcium chloride.

dosage:0,1ml duration: first dose: month 2 of age; second dose: month 4 of age
Active Comparator: fIPV Intradermal
180 children will receive 0,1ml of inactivated poliovirus vaccine intradermally
Biological: Inactivated poliovirus vaccine in reduced doses

contains the following excipients: 2-phenoxyethanol (2.5 mg), water for injection and diluent solution and phosphate buffer having the following composition: sodium phosphate, sodium chloride, potassium chloride, magnesium sulfate, phenol red and calcium chloride.

dosage:0,1ml duration: first dose: month 2 of age; second dose: month 4 of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion
Time Frame: month 5
Difference in seroconversion between arms as expressed by proportion of seropositive children on final blood collection.
month 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Priming
Time Frame: month 4+1week
Difference in priming between arms as expressed by proportion of seropositive children on third blood collection among seronegative children at 2nd bleed
month 4+1week

Collaborators and Investigators

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

Sponsor

Instituto Nacional de Saúde, Mozambique

Collaborators

World Health Organization

Investigators

  • Principal Investigator: Edna Viegas, MD,PhD, INS-CISPOC

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 (Actual)

August 6, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • fIPV-CISPOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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