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Trial record 7 of 32 for:    ipv | polio | Phase 2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04027036
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2019
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Instituto Nacional de Saúde, Mozambique

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polio Biological: Inactivated poliovirus vaccine in reduced doses Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2021


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





Primary Outcome Measures :
  1. Seroconversion [ Time Frame: month 5 ]
    Difference in seroconversion between arms as expressed by proportion of seropositive children on final blood collection.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027036


Locations
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Mozambique
Instituto Nacional de Saúde-Mozambique CISPOC
Maputo, Mozambique, 21-462867
INSMozambique
Maputo, Mozambique
Sponsors and Collaborators
Instituto Nacional de Saúde, Mozambique
World Health Organization
Investigators
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Principal Investigator: Edna Viegas, MD,PhD INS-CISPOC
Publications:

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Responsible Party: Instituto Nacional de Saúde, Mozambique
ClinicalTrials.gov Identifier: NCT04027036    
Other Study ID Numbers: fIPV-CISPOC
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto Nacional de Saúde, Mozambique:
Vaccine
Polio Virus