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
About this trial
This is an interventional prevention trial for HIV Infection
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
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
NCT ID
NCT03041051
First Posted
February 1, 2017
Last Updated
February 1, 2017
Sponsor
Aghia Sophia Children's Hospital of Athens
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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