Evidence map›Paper›PMID 30843046›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.

Peter Vink, Josep Maria Ramon Torrell, Ana Sanchez Fructuoso, Sung-Joo Kim, Sang-Il Kim, Jeff Zaltzman, Fernanda Ortiz, Josep Maria Campistol Plana, Ana Maria Fernandez Rodriguez, Henar Rebollo Rodrigo and 19 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. 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 93 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 6 pooled it
16.3field-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.

NCT02058589 phase3completednot on this map

Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults 18 Years of Age or Older With Renal Transplant

TypeinterventionalSponsorGlaxoSmithKlineRan2014 to 2017Enrolled265ConditionsHerpes ZosterArmsHerpes Zoster vaccine GSK1437173A, Placebo
NCT05351216 recruitingnot on this mapstarted 2021, after this paper: background citation

The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study

TypeobservationalSponsorChildren's Hospital of Fudan UniversityRan2021 to 2028Enrolled174ConditionsKaposiform Hemangioendothelioma
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
NCT07443709 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Single-centre Open-label Parallel Two-arms Pilot Randomized Clinical Trial of a Booster Recombinant Zoster Vaccine in Solid-Organ Transplant Recipients

TypeinterventionalSponsorOriol ManuelRan2026 to 2027Enrolled75ConditionsZoster, HerpesArmsBooster dose of the recombinant zoster vaccine (RZV, Shingrix®)
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 6 syntheses or guidelines pooled it, 190 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Incidence and factors associated with Herpes Zoster infection in kidney transplant recipients, a recent epidemiological study.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Current status of immunisation for herpes zoster.Human vaccines & immunotherapeutics · 2025
    Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 13 countries.

Peter VinkGlaxoSmithKline (GSK), Rockville, Maryland.
Josep Maria Ramon TorrellBellvitge University Hospital, Barcelona.
Ana Sanchez FructuosoHospital Clínico San Carlos, Madrid, Spain.
Sung-Joo KimSungkyunkwan University, Canada.
Sang-Il KimSeoul St Mary's Hospital, College of Medicine, Catholic University of Korea, Republic of Korea.
Jeff ZaltzmanSt Michael's Hospital, University of Toronto, Ontario, Canada.
Fernanda OrtizHelsinki University Hospital, Finland.
Josep Maria Campistol PlanaHospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer.
Ana Maria Fernandez RodriguezHospital Ramón y Cajal, Madrid.
Henar Rebollo RodrigoUniversity Hospital Valdecilla, Santander.
Magda Campins MartiHospital Universitario Vall d'Hebron, Barcelona, Spain.
Rafael PerezSocial Security of Panama, Panama City.
Francisco Manuel González RonceroHospital Universitario Virgen Rocio, Sevilla, Spain.
Deepali KumarUniversity Health Network, Toronto, Ontario, Canada.
Yang-Jen ChiangChang Gung Memorial Hospital, Taoyuan, Taiwan.
Karen DoucetteUniversity of Alberta, Edmonton, Canada.
Lissa PipeleersUZ Brussel, Belgium.
Maria Luisa Agüera MoralesHospital Universitario Reina Sofia, Córdoba.
Maria Luisa Rodriguez-FerreroHospital General Universitario Gregorio Marañón, Madrid, Spain.
Antonio SecchiVita Salute San Reffaele University, Milan, Italy.
Shelly A McNeilCanadian Center for Vaccinology, Izaak Walton Killam Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada.
Laura CamporaGSK, Wavre, Belgium.
Emmanuel Di PaoloGSK, Rixensart, Belgium.
Mohamed El IdrissiGSK, Rixensart, Belgium.
Marta López-FauquedGSK, Wavre, Belgium.
Bruno SalaunGSK, Rixensart, Belgium.
Thomas C HeinemanGSK, King of Prussia, Pennsylvania.
Lidia OostvogelsGSK, Wavre, Belgium.
Z-041 Study Group
GlaxoSmithKline (Belgium) · BESt. Mary's Hospital · USBellvitge University Hospital · ESDalhousie University · CAGlaxoSmithKline (United States) · USHalozyme Therapeutics (United States) · USHospital Clínic de Barcelona · ESHospital Clínico San Carlos · ESHospital General Universitario Gregorio Marañón · ESHospital Universitario Ramón y Cajal · ESHospital Universitario Reina Sofía · ESHospital Universitario Virgen del Rocío · ESMarqués de Valdecilla University Hospital · ESSt. Michael's Hospital · CATaoyuan Chang Gung Memorial Hospital · TWUniversidad Interamericana de Panamá · PAUniversitair Ziekenhuis Brussel · BEUniversity Health Network · CAUniversity of Alberta · CAUniversity of Helsinki · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy.

methodsIn this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2.

resultsTwo hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups.

conclusionsRZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. CLINICAL TRIALS REGISTRATION: NCT02058589.

Indexed as

Herpes ZosterHerpes Zoster VaccineImmunogenicity, VaccineKidney TransplantationAdultAntibodies, ViralHerpesvirus 3, HumanHumansVaccines, SyntheticAntibodies, ViralHerpes Zoster VaccineVaccines, Syntheticherpes zoster vaccineimmunogenicityimmunosuppressionrenal transplantsafety

Identifiers

PMID30843046
PMCPMC6938982
OpenAlexW2922062358

What OpenQuestion holds

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LicenceCC BY
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.