NCT01846923

Brief Summary

The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

April 29, 2013

Last Update Submit

May 1, 2013

Conditions

Aspleniaβ-thalassemia Major

Outcome Measures

Primary Outcomes (2)

  • immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)

    One month post-PCV13

  • immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)

    one month post PCV13

Secondary Outcomes (1)

  • Maintenance of B memory cells three years after PCV13 vaccination

    three years after study vaccination

Study Arms (1)

PCV13

EXPERIMENTAL
Biological: PCV13

Interventions

PCV13BIOLOGICAL
PCV13

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Asplenia
  • β-thalassemia major
  • older than 18 years

You may not qualify if:

  • no previously recorded allergy to PCV
  • no intravenous immunoglobulin (IVIG) given within the previous 6 months
  • no other vaccine given within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

'Aghia Sophia' Children's Hospital

Athens, Attica, 11527, Greece

Location

Related Publications (2)

  • Papadatou I, Lagousi T, Kattamis A, Spoulou V. Antibody persistence 5 years after a 13-valent pneumococcal conjugate vaccine in asplenic patients with beta-thalassemia: assessing the need for booster. Ann Hematol. 2019 Mar;98(3):775-779. doi: 10.1007/s00277-019-03615-z. Epub 2019 Jan 25.

    PMID: 30683996DERIVED

  • Papadatou I, Piperi C, Alexandraki K, Kattamis A, Theodoridou M, Spoulou V. Antigen-specific B-cell response to 13-valent pneumococcal conjugate vaccine in asplenic individuals with beta-thalassemia previously immunized with 23-valent pneumococcal polysaccharide vaccine. Clin Infect Dis. 2014 Sep 15;59(6):862-5. doi: 10.1093/cid/ciu409. Epub 2014 May 30.

    PMID: 24879786DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Paediatrics

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 6, 2013

Study Start

October 1, 2010

Primary Completion

February 1, 2012

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

GR(1)