Evidence map›Paper›PMID 25870329›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged ≥2 years: an open-label study.

Catherine Cordonnier, Per Ljungman, Christine Juergens, Johan Maertens, Dominik Selleslag, Vani Sundaraiyer, Peter C Giardina, Keri Clarke, William C Gruber, Daniel A Scott and 2 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
9.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00980655 phase3completednot on this map

A Phase 3, Open-label Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Followed By 23-valent Pneumococcal Polysaccharide Vaccine In Recipients Of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years And Older

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled251ConditionsVaccines, Pneumococcal Conjugate VaccineArms13vPnC, 23vPS
NCT03619252 phase4completednot on this mapstarted 2018, after this paper: background citation

Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

TypeinterventionalSponsorMinsk Scientific-Practical Center for Surgery, Transplantation and HematologyRan2018 to 2021Enrolled36ConditionsMultiple Myeloma, Pneumococcal Infection, Febrile Neutropenia, Pneumococcal PneumoniaArmsVaccination with pneumococcal conjugate vaccine (PCV13), Standard Antibacterial Prophylaxis
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Vaccination of Adults With Cancer: ASCO Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Guideline
  2. Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2023
    Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Incidence and Predictors of Community-Acquired Pneumonia in Patients With Hematological Cancers Between 2016 and 2019.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 6 countries.

Catherine CordonnierHopital Henri Mondor, Assistance Publique-Hopitaux de Paris, and Université Paris-Est-Créteil, France.
Per LjungmanKarolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
Christine JuergensPfizer Pharma GmbH, Berlin, Germany.
Johan MaertensUniversitaire Ziekenhuizen Gasthuisberg, Leuven.
Dominik SelleslagAZ Sint-Jan Brugge-Oostende, Belgium.
Vani SundaraiyerinVentiv Health Clinical, LLC, Princeton, New Jersey.
Peter C GiardinaPfizer Inc, Pearl River, New York;
Keri ClarkePfizer Inc, Surrey, United Kingdom.
William C GruberPfizer Inc, Pearl River, New York;
Daniel A ScottPfizer Inc, Pearl River, New York;
Beate Schmoele-ThomaPfizer Pharma GmbH, Berlin, Germany.
3003 Study Group
Pfizer (United States) · USPfizer (Germany) · DEAZ Sint-Jan · BEKarolinska Institutet · SEKU Leuven · BEPrinceton University · USUniversité Paris-Est Créteil · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLife-threatening Streptococcus pneumoniae infections often occur after hematopoietic stem cell transplant (HSCT); vaccination is important for prevention.

methodsIn an open-label study, patients (n = 251) 3-6 months after allogeneic HSCT received 3 doses of 13-valent pneumococcal conjugate vaccine (PCV13) at 1-month intervals, a fourth dose 6 months later, and 1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month later. Immunogenicity at prespecified time points and vaccine safety were assessed.

resultsIn the evaluable immunogenicity population (N = 216; mean age, 37.8 years), geometric mean fold rises (GMFRs) of immunoglobulin G geometric mean concentrations from baseline to postdose 3 showed significant increases in antibody levels across all PCV13 serotypes (GMFR range, 2.99-23.85; 95% confidence interval lower limit, >1); there were significant declines over the next 6 months, significant increases from predose 4 to postdose 4 (GMFR range, 3.00-6.97), and little change after PPSV23 (GMFR range, 0.86-1.12). Local and systemic reactions were more frequent after dose 4. Six patients experienced serious adverse events possibly related to PCV13 (facial diplegia, injection-site erythema and pyrexia, autoimmune hemolytic anemia, and suspected lack of vaccine efficacy after dose 3 leading to pneumococcal infection), PCV13 and PPSV23 (Guillain-Barré syndrome), or PPSV23 (cellulitis). There were 14 deaths, none related to study vaccines.

conclusionsA 3-dose PCV13 regimen followed by a booster dose may be required to protect against pneumococcal disease in HSCT recipients. Dose 4 was associated with increased local and systemic reactions, but the overall safety profile of a 4-dose regimen was considered acceptable. CLINICAL TRIALS REGISTRATION: NCT00980655.

Indexed as

AdolescentAntibodies, BacterialChildChild, PreschoolFemaleHematopoietic Stem Cell TransplantationHumansImmunoglobulin GMalePneumococcal InfectionsPneumococcal Vaccines13-valent pneumococcal vaccine23-valent pneumococcal capsular polysaccharide vaccineAntibodies, BacterialImmunoglobulin GPneumococcal Vaccines13-valent pneumococcal conjugate vaccine23-valent pneumococcal polysaccharide vaccinehematopoietic stem cell transplantStreptococcus pneumoniae infections

Identifiers

PMID25870329
PMCPMC4503811
OpenAlexW2138829575

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.