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A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV

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ClinicalTrials.gov Identifier: NCT03239496
Recruitment Status : Completed
First Posted : August 4, 2017
Results First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Fidec Corporation

Study Description
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Brief Summary:
The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: IPV Biological: f-IPV Phase 3

Detailed Description:

This study prioritizes comparisons involving two-dose regimens recently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE) and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21. Furthermore, the study will provide data on the comparative humoral immunogenicity of various schedules to inform polio immunization policy for the post-eradication era.

The study population will include infants in Dominican Republic and Panama. Absence of wild and circulating vaccine derived polioviruses along with the lack of regular Supplementary Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic setting to study polio vaccine immunogenicity.

Infants will receive two or three doses of full-dose IPV IM or f-IPV ID, in two schedules (10, 14 and 36 weeks and 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses.

A total of 773 infants will be enrolled and distributed into 4 groups, according to a randomization scheme. During the study period, infants will be administered other concomitant vaccines according to the national schedules of the participating countries, but the effect, if any, of the concomitant administration on IPV immunogenicity will not be assessed.

Optimum immunogenicity expected from the dose(s) of IPV in the post-eradication era will have to be balanced with the cost and supply constraints of IPV. This study will be critical to determine how many doses of IPV and which schedule are optimal for the post-eradication era after the global cessation of Oral Polio Vaccine (OPV) use.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 773 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full-Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants
Actual Study Start Date : October 23, 2017
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.
 Biological: IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Experimental: Group B
2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
 Biological: IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Experimental: Group C
3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.
 Biological: f-IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Experimental: Group D
2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
 Biological: f-IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)


Outcome Measures
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Primary Outcome Measures :
  1. Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM [ Time Frame: To be assessed 4 weeks after the last dose ]
    To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.

  2. Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM [ Time Frame: To be assessed 4 weeks after the last dose ]
    To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.

  3. Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID [ Time Frame: To be assessed 4 weeks after the last dose ]
    To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.


Secondary Outcome Measures :
  1. Seroconversion Superiority of 2 Doses IPV IM at Different Schedules [ Time Frame: To be assessed 4 weeks after the second dose ]
    To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.

  2. Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules [ Time Frame: To be assessed 4 weeks after the second dose ]
    To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.

  3. Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM [ Time Frame: To be assessed 4 weeks after the last dose ]
    To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.

  4. Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM [ Time Frame: To be assessed 4 weeks after the last dose ]
    To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.

  5. Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM [ Time Frame: To be assessed 4 weeks after the last dose ]
    To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.

  6. Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions [ Time Frame: To be assessed throughout the complete study period, approx. 13 months ]
    To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions.


Eligibility Criteria
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Ages Eligible for Study:   5 Weeks to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.
  2. Healthy, as assessed from medical history and physical examination by a study physician,
  3. Written informed consent obtained from parents or legal representatives who have been properly informed about the study and are able to comply with planned study procedures.

Exclusion Criteria:

  1. Vaccinated with any poliovirus vaccine prior to inclusion,
  2. A household contact with OPV vaccination history in the past 4 weeks,
  3. HIV infection or pharmacologic immunosuppression,
  4. Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),
  5. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections,
  6. Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be a contraindication for vaccination,
  7. Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator(s).
Contacts and Locations
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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): NCT03239496


Locations
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Dominican Republic
Hospital Universitario Nuestra Señora de la Alta Gracia
Santo Domingo, Dominican Republic
Panama
Cevaxin Vaccination Center
David, Panama
Cevaxin Vaccination Center
La Chorrera, Panama
Cevaxin Vaccination Center
Panama city, Panama
Sponsors and Collaborators
Fidec Corporation
Bill and Melinda Gates Foundation
  Study Documents (Full-Text)

Documents provided by Fidec Corporation:
Study Protocol and Statistical Analysis Plan  [PDF] April 12, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fidec Corporation
ClinicalTrials.gov Identifier: NCT03239496    
Other Study ID Numbers: IPV004
First Posted: August 4, 2017    Key Record Dates
Results First Posted: August 18, 2020
Last Update Posted: August 18, 2020
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
 Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases