Evidence map›Paper›PMID 25888646›Full record

Trial reportAIDS (London, England)2015

Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination.

As'ad E Bhorat, Shabir A Madhi, France Laudat, Vani Sundaraiyer, Alejandra Gurtman, Kathrin U Jansen, Daniel A Scott, Emilio A Emini, William C Gruber, Beate Schmoele-Thoma

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in AIDS (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
6.5field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. 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
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine Against Hospitalization for Community-Acquired Pneumonia in Older US Adults: A Test-Negative Design.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Review
  18. 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

10 authors at 4 institutions in 3 countries.

As'ad E BhorataSoweto Clinical Trials Centre bMedical Research Council: Respiratory and Meningeal Pathogens Research Unit & Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of Witwatersrand, Johannesburg, South Africa cPfizer Vaccine Research, Pearl River, New York dInVentiv Health Clinical, LLC, Princeton, New Jersey, USA ePfizer Pharma, GmbH, Berlin, Germany.
Shabir A Madhi
France Laudat
Vani Sundaraiyer
Alejandra Gurtman
Kathrin U Jansen
Daniel A Scott
Emilio A Emini
William C Gruber
Beate Schmoele-Thoma
Pfizer (United States) · USGTx (United States) · USPfizer (Germany) · DERespiratory and Meningeal Pathogens Research Unit · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveImmunocompromised individuals are at an increased risk of pneumococcal disease. Vaccination is recommended as an important strategy to reduce risk of pneumococcal disease in HIV-infected individuals. This study evaluated the safety and immunogenicity of three 13-valent pneumococcal conjugate vaccine (PCV13) doses followed by one dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at 1-month intervals in pneumococcal vaccine-naive, HIV-infected individuals.

designThis was a phase 3, open-label, single-arm study.

methodsPneumococcal vaccine-naive, HIV-infected individuals at least 6 years of age with CD4 T-cell count at least 200  cells/μl and viral load less than 50 000  copies/ml received three doses of PCV13 followed by one dose of PPSV23 at 1-month intervals. Serotype-specific antipneumococcal immune responses were assessed by IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) assay geometric mean titres (GMTs) after each dose. Local reactions at the PCV13 injection site, systemic and other adverse events were collected.

resultsThree hundred and one individuals were enrolled and vaccinated; 279 completed the study. Statistically significant increases in IgG GMCs and OPA GMTs were observed for all serotypes after dose 1 of PCV13 compared with prevaccine levels. GMCs and GMTs were comparable or only modestly increased for all serotypes after PCV13 doses 2 and 3 and after PPSV23. The majority of local reactions and systemic events were mild to moderate in severity.

conclusionA three-dose regimen of PCV13 was well tolerated in pneumococcal vaccine-naive, HIV-infected individuals. Significant immune responses to all serotypes were observed following the first dose of PCV13, with only modest increases in antibody titres following subsequent PCV13 or PPSV23 administration.

Indexed as

AdolescentAdultAntibodies, BacterialCD4 Lymphocyte CountChildFemaleHIV InfectionsHumansImmunization ScheduleImmunization, SecondaryMaleMiddle AgedPneumococcal InfectionsPneumococcal VaccinesStreptococcus pneumoniaeViral Load13-valent pneumococcal vaccine23-valent pneumococcal capsular polysaccharide vaccineAntibodies, BacterialPneumococcal Vaccines

Identifiers

PMID25888646
PMCPMC4521829
OpenAlexW2332125701

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.