Evidence map›Paper›PMID 34963639›Full record

Trial reportThe Journal of infection2022

The adjuvanted recombinant zoster vaccine co-administered with the 13-valent pneumococcal conjugate vaccine in adults aged ≥50 years: A randomized trial.

Ji-Young Min, Agnes Mwakingwe-Omari, Megan Riley, Lifeter Yenwo Molo, Jyoti Soni, Ginette Girard, Jasur Danier

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The Journal of infection, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03439657 (Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 14% 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.

NCT03439657 phase3completednot on this map

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2020Enrolled913ConditionsHerpes ZosterArmsHZ/su vaccine GSK1437173A, Prevenar13
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Vaccines for preventing herpes zoster in older adults.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Trial
  4. Article
  5. Journal of preventive medicine and hygiene · 2026
    Article
  6. Herpes Zoster in Aging Patients: Risk Factors and Prevention Strategies.International journal of general medicine · 2026
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

Ji-Young MinGSK, 14200 Shady Grove Rd., Rockville, MD, United States.
Agnes Mwakingwe-OmariGSK, 14200 Shady Grove Rd., Rockville, MD, United States. Electronic address: agnes.x.mwakingwe-omari@gsk.com.
Megan RileyGSK, 14200 Shady Grove Rd., Rockville, MD, United States.
Lifeter Yenwo MoloGSK, Avenue Fleming 20, 1300 Wavre, Belgium.
Jyoti SoniGSK, Level 4, Prestige Trade Tower, 46, Palace Road, Sampangi Rama Nagar, Bengaluru, Karnataka 560001, India.
Ginette GirardDIEX Recherche Sherbrooke, Sherbrooke, QC, Canada.
Jasur DanierGSK, 14200 Shady Grove Rd., Rockville, MD, United States. Electronic address: jasur.x.danier@gsk.com.
Universities at Shady Grove · USGlaxoSmithKline (Belgium) · BEGlaxoSmithKline (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHerpes zoster (HZ) results from reactivation of latent varicella-zoster virus. Adults at increased risk of HZ (due to immunocompromising conditions or older age) are also at risk of pneumococcal disease, both of which are preventable by vaccination. We evaluated simultaneous versus sequential administration of the adjuvanted recombinant zoster vaccine (RZV) and the 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥50 years.

methodsIn this phase IIIB multinational trial (NCT03439657), participants were randomized 1:1 to receive either the first RZV dose and PCV13 simultaneously followed by the second RZV dose two months later (Co-Ad, N = 449), or at two-month intervals, PCV13, the first RZV dose, and the second RZV dose sequentially (Control, N = 463). Objectives were to demonstrate that immune responses to both vaccines are non-inferior when co-administered compared to sequential administration and to evaluate the safety of their co-administration.

resultsThe RZV vaccine response rate (VRR) in the Co-Ad group was 99.1% (95% confidence interval [CI]: 97.6-99.7), meeting the VRR success criterion. Non-inferiority criteria for the Co-Ad versus Control group were also met for anti-glycoprotein E antibodies (adjusted geometric mean concentration Control/Co-Ad ratio 1.07 [95%CI: 0.99-1.16]) and all PCV13 serotypes (adjusted antibody geometric mean titer Control/Co-Ad ratios 1.02 [95%CI: 0.86-1.22] to 1.36 [95%CI: 1.07-1.73]). Upon co-administration, the frequency of solicited local adverse events was consistent with the known safety profile of each individual vaccine, whereas solicited general adverse events were within the same range as for RZV alone.

conclusionsRZV co-administered with PCV13 had an acceptable safety profile. Humoral immune responses to both vaccines were non-inferior when co-administered compared to sequential administration. These results suggest that adults may benefit from receiving RZV and a PCV at the same healthcare visit.

Indexed as

Herpes ZosterHerpes Zoster VaccinePneumococcal InfectionsAdultHerpesvirus 3, HumanHumansPneumococcal VaccinesVaccines, ConjugateVaccines, SyntheticHerpes Zoster VaccinePneumococcal VaccinesVaccines, ConjugateVaccines, Synthetic13-Valent pneumococcal conjugate vaccineCo-administrationImmune responseRecombinant zoster vaccineSafety

Identifiers

PMID34963639
OpenAlexW4200509387

What OpenQuestion holds

Textmetadata
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.