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Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

Primary Purpose

Human Influenza

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Agripal
IDflu9μg
IDflu15μg
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Influenza

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine

Exclusion Criteria:

  • known allergy to egg
  • presentation of any febrile illness ≥37.5°C on the day of vaccination
  • any history of hypersensitivity reaction to previous influenza vaccination
  • any other vaccinations within the past one month
  • use of immunosuppressive agent
  • recipient of blood product or immunoglobulins during the previous three months
  • any other conditions that might interfere with the study results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Agripal

    IDflu9μg

    IDflu15μg

    Arm Description

    28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0

    30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0

    28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0

    Outcomes

    Primary Outcome Measures

    The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10

    Secondary Outcome Measures

    Percentage of subjects with a post-vaccination titer ≥1:40
    GMT ratio of the post-vaccination titer to pre-vaccination titer

    Full Information

    First Posted
    March 1, 2015
    Last Updated
    March 24, 2015
    Sponsor
    Korea University Guro Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02398097
    Brief Title
    Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects
    Official Title
    Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Guro Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.
    Detailed Description
    During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Influenza

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    88 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Agripal
    Arm Type
    Active Comparator
    Arm Description
    28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0
    Arm Title
    IDflu9μg
    Arm Type
    Active Comparator
    Arm Description
    30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0
    Arm Title
    IDflu15μg
    Arm Type
    Active Comparator
    Arm Description
    28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Agripal
    Intervention Description
    2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
    Intervention Type
    Biological
    Intervention Name(s)
    IDflu9μg
    Intervention Description
    2011/2012 influenza season reduced-content intradermal split vaccine, single dose
    Intervention Type
    Biological
    Intervention Name(s)
    IDflu15μg
    Intervention Description
    2011/2012 influenza season standard-content intradermal split vaccine, single dose
    Primary Outcome Measure Information:
    Title
    The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
    Time Frame
    Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
    Secondary Outcome Measure Information:
    Title
    Percentage of subjects with a post-vaccination titer ≥1:40
    Time Frame
    Outcome measure was assessed 4 weeks after vaccination
    Title
    GMT ratio of the post-vaccination titer to pre-vaccination titer
    Time Frame
    Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
    Other Pre-specified Outcome Measures:
    Title
    Frequency and duration of local and systemic adverse events
    Description
    The diary was made based on the Food and Drug Association (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
    Time Frame
    Adverse events were recorded for 7 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine Exclusion Criteria: known allergy to egg presentation of any febrile illness ≥37.5°C on the day of vaccination any history of hypersensitivity reaction to previous influenza vaccination any other vaccinations within the past one month use of immunosuppressive agent recipient of blood product or immunoglobulins during the previous three months any other conditions that might interfere with the study results
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hee Jin Cheong, MD, PhD
    Organizational Affiliation
    Korea University Guro Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26431466
    Citation
    Seo YB, Lee J, Song JY, Choi HJ, Cheong HJ, Kim WJ. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother. 2016;12(2):478-84. doi: 10.1080/21645515.2015.1076599.
    Results Reference
    derived

    Learn more about this trial

    Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

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