Evidence map›Paper›PMID 25371534›Full record

Trial reportThe Journal of infectious diseases2015

Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study.

Elchonon M Berkowitz, Graeme Moyle, Hans-Jürgen Stellbrink, Dirk Schürmann, Stephen Kegg, Matthias Stoll, Mohamed El Idrissi, Lidia Oostvogels, Thomas C Heineman, Zoster-015 HZ/su Study Group

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 94 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 4 pooled it
9.9field-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.

NCT01165203 phase2completednot on this map

Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A in Adult HIV-infected Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2013Enrolled123ConditionsHerpes ZosterArmsHerpes Zoster Vaccine GSK1437173A, Placebo
NCT05580458 phase1 / phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for People With HIV With CD4 Counts Under and Above 300 and Healthy Volunteers Following Shingrix Vaccination (ZEUS)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2023 to 2027Enrolled225ConditionsHerpes ZosterArmsShingrix
NCT05879419 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Efficacy, Immunogenicity and Safety of Recombinant Vaccine Against Herpes Zoster (RZV or SHINGRIX®) in Patients With Autoimmune Rheumatic Diseases

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2023 to 2032Enrolled2,005ConditionsRheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus ErythematosusArmsRecombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation, MMF Discontinuation, Placebo, MTX maintain
NCT05898464 phase4completednot on this mapstarted 2023, after this paper: background citation

Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV

TypeinterventionalSponsorSeoul National University HospitalRan2023 to 2026Enrolled71ConditionsVaccination, Infection, Vaccine Adverse ReactionArmsRecombinant zoster vaccination
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 4 syntheses or guidelines pooled it, 210 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Herpes Zoster Risk in Immunocompromised Adults in the United States: A Systematic Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Development of mRNA vaccines against herpes zoster.Human vaccines & immunotherapeutics · 2026
    Review
  10. Article
  11. Article
  12. Review
  13. Current status of immunisation for herpes zoster.Human vaccines & immunotherapeutics · 2025
    Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Challenges and recommendations of vaccination in immunosuppression.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025
    Article

34 more citing papers are in PubMed but not listed here.

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 7 institutions in 4 countries.

Elchonon M BerkowitzGlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Graeme MoyleChelsea and Westminster Hospital.
Hans-Jürgen StellbrinkInfektionsmedizinisches Centrum Hamburg.
Dirk SchürmannDepartment of Infectious Diseases and Pulmonary Medicine, Charité-Universitätsmedizin Berlin.
Stephen KeggQueen Elizabeth Hospital NHS Trust, The Trafalgar Clinic, London, United Kingdom.
Matthias StollMedizinische Hochschule Hannover, Zentrum Innere Medizin, Klinische Immunologie II, Germany.
Mohamed El IdrissiGlaxoSmithKline Vaccines, Wavre, Belgium.
Lidia OostvogelsGlaxoSmithKline Vaccines, Wavre, Belgium.
Thomas C HeinemanGlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Zoster-015 HZ/su Study Group
GlaxoSmithKline (United States) · USGlaxoSmithKline (Belgium) · BEMedizinische Hochschule Hannover · DECharité - Universitätsmedizin Berlin · DEChelsea and Westminster Hospital · GBInfektionsmedizinisches Centrum Hamburg · DEQueen Elizabeth Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman immunodeficiency virus (HIV)-infected individuals are at increased risk of herpes zoster (HZ), even in the antiretroviral therapy (ART) era. Because concerns exist about the use of live-attenuated vaccines in immunocompromised individuals, a subunit vaccine may be an appropriate alternative.

methodsThis phase 1/2, randomized, placebo-controlled study evaluated the immunogenicity and safety of an investigational HZ subunit vaccine (HZ/su). Three cohorts of HIV-infected adults aged ≥18 years were enrolled: 94 ART recipients with a CD4(+) T-cell count of ≥200 cells/mm(3), 14 ART recipients with a CD4(+) T-cell count of 50-199 cells/mm(3), and 15 ART-naive adults with a CD4(+) T-cell count of ≥500 cells/mm(3). Subjects received 3 doses of HZ/su (50 µg varicella-zoster virus glycoprotein E [gE] combined with AS01B adjuvant) or 3 doses of saline at months 0, 2, and 6.

resultsOne month after dose 3, serum anti-gE antibody concentrations and frequencies of gE-specific CD4(+) T cells were higher following HZ/su vaccination than after receipt of saline (P < .0001). Median cell-mediated immune responses peaked after dose 2. Humoral and cell-mediated immune responses persisted until the end of the study (month 18). No vaccination-related serious adverse events were reported. No sustained impact on HIV load or CD4(+) T-cell count was noted following vaccinations.

conclusionsHZ/su was immunogenic and had a clinically acceptable safety profile in HIV-infected adults. CLINICAL TRIALS REGISTRATION: NCT01165203.

Indexed as

Adjuvants, ImmunologicAdjuvants, PharmaceuticAntibodies, ViralAntibody FormationCD4-Positive T-LymphocytesFemaleHerpesvirus 3, HumanHerpes ZosterHerpes Zoster VaccineHIV InfectionsHumansMaleMiddle AgedVaccinationVaccines, SubunitAdjuvants, ImmunologicAdjuvants, PharmaceuticAntibodies, ViralHerpes Zoster VaccineVaccines, Subunitglycoprotein Eherpes zosterHIV infectionimmunodeficiencyvaricella-zoster viruszoster vaccine

Identifiers

PMID25371534
PMCPMC4371767
OpenAlexW2123574813

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.