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
About this trial
This is an interventional prevention trial for Streptococcal Pneumonia
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
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
NCT ID
NCT03838497
First Posted
February 10, 2019
Last Updated
February 10, 2019
Sponsor
Korea University Guro Hospital
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
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