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Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients

Primary Purpose

HIV Infection

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PCV13
PPV23
Sponsored by
Aghia Sophia Children's Hospital of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CD4 T cell count >200cells/μl
  • on ART

Exclusion Criteria:

  • no previously recorded allergy to PCV, PPV23
  • no intravenous immunoglobulin (IVIG) given within the previous 6 months
  • no other vaccine given within the previous 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    PCV13

    PPV23

    Arm Description

    Outcomes

    Primary Outcome Measures

    immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
    immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
    immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
    immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2017
    Last Updated
    February 1, 2017
    Sponsor
    Aghia Sophia Children's Hospital of Athens
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03041051
    Brief Title
    Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients
    Official Title
    Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (Actual)
    Primary Completion Date
    March 1, 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aghia Sophia Children's Hospital of Athens

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCV13
    Arm Type
    Experimental
    Arm Title
    PPV23
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    PCV13
    Intervention Type
    Biological
    Intervention Name(s)
    PPV23
    Primary Outcome Measure Information:
    Title
    immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
    Description
    immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
    Time Frame
    One month post-PCV13, PPV23
    Title
    immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
    Description
    immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
    Time Frame
    One month post-PCV13, PPV23

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: CD4 T cell count >200cells/μl on ART Exclusion Criteria: no previously recorded allergy to PCV, PPV23 no intravenous immunoglobulin (IVIG) given within the previous 6 months no other vaccine given within the previous 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vana Spoulou
    Organizational Affiliation
    Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29722823
    Citation
    Farmaki PF, Chini MC, Mangafas NM, Tzanoudaki MT, Piperi CP, Lazanas MZ, Spoulou VS. Immunogenicity and Immunological Memory Induced by the 13-Valent Pneumococcal Conjugate Followed by the 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. J Infect Dis. 2018 Jun 5;218(1):26-34. doi: 10.1093/infdis/jiy135.
    Results Reference
    derived

    Learn more about this trial

    Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients

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