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NCT03041051 Clinical Trial

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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03041051
Other study ID # 51198eAS
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received February 1, 2017
Last updated February 1, 2017
Start date December 2015
Est. completion date March 2017

Study information
Verified date February 2017
Source Aghia Sophia Children's Hospital of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date March 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• PCV13

• PPV23

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Aghia Sophia Children's Hospital of Athens

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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