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

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ClinicalTrials.gov Identifier: NCT03041051
Recruitment Status : Unknown
Verified February 2017 by Vana Spoulou, Aghia Sophia Children's Hospital of Athens.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Vana Spoulou, Aghia Sophia Children's Hospital of Athens

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 2, 2017
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry) [ Time Frame: One month post-PCV13, PPV23 ]
    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) [ Time Frame: One month post-PCV13, PPV23 ]
    immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients
Official Title  ICMJE Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • Biological: PCV13
  • Biological: PPV23
Study Arms  ICMJE
  • Experimental: PCV13
    Intervention: Biological: PCV13
  • Experimental: PPV23
    Intervention: Biological: PPV23
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041051
Other Study ID Numbers  ICMJE 51198eAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vana Spoulou, Aghia Sophia Children's Hospital of Athens
Study Sponsor  ICMJE Aghia Sophia Children's Hospital of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vana Spoulou Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527
PRS Account Aghia Sophia Children's Hospital of Athens
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP