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Status unknownNCT03041051Updated Feb 2, 2017

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

A Phase 4 interventional study of PCV13 and PPV23 in HIV Infection, sponsored by Aghia Sophia Children's Hospital of Athens. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-02.

Sponsored by Aghia Sophia Children's Hospital of Athens · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Dec 2015, registered Feb 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infection

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03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 40 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.

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Lead sponsor

Aghia Sophia Children's Hospital of Athens is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • CD4 T cell count >200cells/μl
  • on ART

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    PCV13

    Biological: PCV13

  • Experimental
    PPV23

    Biological: PPV23

Interventions

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: One month post-PCV13, PPV23

  2. 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)

    Time frame: One month post-PCV13, PPV23

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29722823 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2015 (actual). Primary completion is estimated for Mar 2017, 15 months after the start.

Of 88 non-industry phase 4 interventional studies under HIV Infections, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 45. This study's planned 15 months is below that.

Counting every sponsor, half of 99 studies reached it within 29 months; a quarter within 19 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2017
First posted
Feb 2, 2017
StartActual
Dec 2015
Primary completionEst.
Mar 1, 2017
CompletionEst.
Mar 2017
Last update
Feb 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03041051
Lead sponsor
Aghia Sophia Children's Hospital of Athens
Responsible party
Vana Spoulou (Associate Professor of Pediatric Infectious Diseases, Aghia Sophia Children's Hospital of Athens) — Principal investigator
First posted
Feb 2, 2017
Start date
Dec 2015
Primary completion
Mar 1, 2017 (estimated)
Completion
Mar 2017 (estimated)
Last update
Feb 2, 2017

Study contacts

Vana Spoulou
principal investigator · Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: 13-valent pneumococcal vaccine · 23-valent pneumococcal capsular polysaccharide vaccine

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Other studies from this sponsor

Aghia Sophia Children's Hospital of Athens

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