search
Back to results

Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults

Primary Purpose

Streptococcal Pneumonia, HIV/AIDS

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Prevenar13
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcal Pneumonia

Eligibility Criteria

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

Inclusion Criteria:

  • HIV-infeted subjects who received antiretroviral therapy for ≥ 4 weeks

Exclusion Criteria:

  • a history of pneumococcal infection within the recent five years
  • previous pneumococcal vaccination
  • current opportunistic infections
  • known immunodeficiency other than HIV infection
  • coagulation disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    HIV-infected subjects with CD4 T-cell counts <350 cells/µL

    HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL

    Arm Description

    Intervention to be administered: Prevenar13

    Intervention to be administered: Prevenar13

    Outcomes

    Primary Outcome Measures

    Opsonophagocytic assay (OPA) titers for PCV13
    OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results

    Secondary Outcome Measures

    Frequency and duration of local and systemic adverse events
    The safety profiles of co-administration of Fluad and PCV13 will be compared to those of single vaccination.

    Full Information

    First Posted
    February 10, 2019
    Last Updated
    February 10, 2019
    Sponsor
    Korea University Guro Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03838497
    Brief Title
    Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults
    Official Title
    Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults in the Era of Highly Active Antiretroviral Therapy: Analysis Stratified by CD4 T-cell Count
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2, 2015 (Actual)
    Primary Completion Date
    January 31, 2017 (Actual)
    Study Completion Date
    February 28, 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases. Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts <350 cells/µL). Multiplex opsonophagocytic killing assay was used to compare immunogenicity after the immunization of 13-valent pneumococcal conjugate vaccine (PCV13).
    Detailed Description
    This single-center, open-label non-randomized clinical trial was conducted at Korea University Guro Hospital from April 2015 to January 2017. Based on the CD4 T-cell counts at the time of study enrollment, HIV-infected subjects aged ≥ 18 years were divided into two groups, group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts <350 cells/µL). The primary objective of the study was to demonstrate that the immune responses to PCV13 serotypes in Group 2 (CD4 T-cell counts <350 cells/µL) were not inferior to those in Group 1 (CD4 T-cell counts ≥350 cells/µL) at one month after vaccination. In addition, the safety profiles of PCV13 were compared between two study groups. HIV-infected subjects aged ≥ 18 years with stable underlying diseases (≥ 4 weeks on HAART) were eligible for this study. All available subjects with low CD4 T-cell counts (<350 cells/µL, group 2) were recruited, and age/visit day-matched controls with high CD4 T-cell counts (≥350 cells/µL, group 1) were enrolled. The exclusion criteria were as follows: 1) a history of pneumococcal infection within the recent five years, 2) previous pneumococcal vaccination, 3) current opportunistic infections, 4) known immunodeficiency other than HIV infection and 5) coagulation disorders. The study was approved by the ethics committee of Korea University Guro Hospital (IRB No. 2014GR0014) and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Informed consent was taken for all participants before enrollment. Venous blood samples of 10 mL were collected on day 0 and post-vaccination day 28 ± 7.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Streptococcal Pneumonia, HIV/AIDS

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HIV-infected subjects with CD4 T-cell counts <350 cells/µL
    Arm Type
    Active Comparator
    Arm Description
    Intervention to be administered: Prevenar13
    Arm Title
    HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL
    Arm Type
    Active Comparator
    Arm Description
    Intervention to be administered: Prevenar13
    Intervention Type
    Biological
    Intervention Name(s)
    Prevenar13
    Intervention Description
    Prevenar13 for both arms
    Primary Outcome Measure Information:
    Title
    Opsonophagocytic assay (OPA) titers for PCV13
    Description
    OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results
    Time Frame
    Outcome measure will be assessed at two points (baseline and 28 ± 7 days after vaccination).
    Secondary Outcome Measure Information:
    Title
    Frequency and duration of local and systemic adverse events
    Description
    The safety profiles of co-administration of Fluad and PCV13 will be compared to those of single vaccination.
    Time Frame
    All participants will be followed until 4 weeks after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV-infeted subjects who received antiretroviral therapy for ≥ 4 weeks Exclusion Criteria: a history of pneumococcal infection within the recent five years previous pneumococcal vaccination current opportunistic infections known immunodeficiency other than HIV infection coagulation disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults

    We'll reach out to this number within 24 hrs