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

NCT ID: NCT03041051

Last Updated: 2017-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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HIV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PCV13

Group Type EXPERIMENTAL

PCV13

Intervention Type BIOLOGICAL

PPV23

Group Type EXPERIMENTAL

PPV23

Intervention Type BIOLOGICAL

Interventions

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PCV13

Intervention Type BIOLOGICAL

PPV23

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aghia Sophia Children's Hospital of Athens

OTHER

Sponsor Role lead

Responsible Party

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Vana Spoulou

Associate Professor of Pediatric Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vana Spoulou

Role: PRINCIPAL_INVESTIGATOR

Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527

References

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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.

Reference Type DERIVED
PMID: 29722823 (View on PubMed)

Other Identifiers

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51198eAS

Identifier Type: -

Identifier Source: org_study_id

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