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

February 1, 2017 updated by: Vana Spoulou, Aghia Sophia Children's Hospital of Athens

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCV13
Biological: PCV13
Experimental: PPV23
Biological: PPV23

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
One month post-PCV13, PPV23
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)
One month post-PCV13, PPV23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aghia Sophia Children's Hospital of Athens

Investigators

  • Principal Investigator: Vana Spoulou, Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51198eAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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