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

Phase 4

• Conditions: HIV Infection
• Interventions: Biological: PCV13; Biological: PPV23

• Registration Number: NCT03041051
• Lead Sponsor: Aghia Sophia Children's Hospital of Athens

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 available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2017-02
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02
• Primary Completion: 2017-03-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCV13	PCV13	-
PPV23	PPV23	-

Primary Outcome Measures

Name	Time	Method
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)	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)	One month post-PCV13, PPV23	immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)