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

Aghia Sophia Children's Hospital of Athens

Status and phase: Unknown; Phase 4

Conditions: HIV Infection

Treatments: Biological: PPV23; Biological: PCV13

Study type: Interventional

Funder types: Other

Identifiers

NCT03041051

51198eAS

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

PCV13

Experimental group

Treatment:

Biological: PCV13

PPV23

Experimental group

Treatment:

Biological: PPV23