Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients
Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 2, 2017
February 1, 2017
1.2 years
February 1, 2017
February 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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)
One month post-PCV13, PPV23
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)
One month post-PCV13, PPV23
Study Arms (2)
PCV13
EXPERIMENTALPPV23
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- CD4 T cell count \>200cells/μl
- on ART
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29722823DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vana Spoulou
Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatric Infectious Diseases
Study Record Dates
First Submitted
February 1, 2017
First Posted
February 2, 2017
Study Start
December 1, 2015
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
February 2, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share