Evidence map›Paper›PMID 30691396›Full record

ArticleBMC infectious diseases2019

Safety of live attenuated varicella-zoster vaccine in patients with underlying illnesses compared with healthy adults: a prospective cohort study.

Satoko Ohfuji, Kazuya Ito, Megumi Inoue, Motoki Ishibashi, Hiroko Kumashiro, Yoshio Hirota, Eiji Kayano, Naoshi Ota

Open access · goldAbstract readControlled Clinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 4 pooled it
1.3field-weighted citation impact, top 20% 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

10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  5. Trends in public interest and vaccination coverage for Herpes Zoster.Public health in practice (Oxford, England) · 2025
    Article
  6. Review
  7. Review
  8. Article
  9. Observational
  10. Varicella zoster virus vaccines: an update.ImmunoTargets and therapy · 2019
    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

8 authors at 3 institutions in 1 country.

Satoko OhfujiDepartment of Public Health, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka-city, Osaka, 545-8585, Japan. satop@med.osaka-cu.ac.jp.
Kazuya ItoDepartment of Public Health, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka-city, Osaka, 545-8585, Japan.
Megumi InouePS Clinic, Medical Co. LTA, 6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka, 812-0025, Japan.
Motoki IshibashiPS Clinic, Medical Co. LTA, 6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka, 812-0025, Japan.
Hiroko KumashiroPS Clinic, Medical Co. LTA, 6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka, 812-0025, Japan.
Yoshio HirotaClinical Epidemiology Research Center, Medical Co. LTA, 3-6-1 Kashii-Teriha Higashi-ku, Fukuoka, 813-0017, Japan.
Eiji KayanoKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 4-1-70, Seto-Cho, Kanonji, Kagawa, 768-0065, Japan.
Naoshi OtaKanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 4-1-70, Seto-Cho, Kanonji, Kagawa, 768-0065, Japan.
Osaka City University · JPOsaka University · JPFukuoka Higashi Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Japan, freeze-dried live attenuated varicella-zoster vaccine is available for adults aged ≥50 years to prevent herpes zoster. However, limited evidence has been accumulated regarding vaccine safety for patients with underlying illnesses, who have been considered as the high-risk group for herpes zoster.

methodsA prospective cohort study of 1200 healthy adults and 300 patients with underlying illnesses such as malignancy, diabetes mellitus, autoimmune diseases, and renal diseases was conducted. All subjects were vaccinated and then their adverse events (AEs) were followed for 28 days after vaccination. Key safety measures included any AEs, severe AEs (SAEs), and vaccine-related AEs such as injection-site AEs and systemic AEs. The frequencies and 95% confidence intervals of AEs were calculated.

resultsDuring the follow-up period, 2 SAEs (bone fracture and acute cholecystitis) among healthy adults and 1 SAE (disseminated mycobacteriosis) among patients with underlying illnesses were reported, although none of them was diagnosed as vaccine-related. Vaccine-related AEs were reported in 42% of healthy adults and patients with underlying illnesses, and the proportions were similar between the groups. The most frequent AEs were injection-site AEs in both groups (i.e., 41 and 39%), and systemic AEs were observed in 4% of both groups. Only among healthy adults, those with a history of herpes zoster were more likely to report injection-site AEs than those without a history of herpes zoster (53% vs 39%).

conclusionsThe present study confirmed the safety of freeze-dried, live attenuated varicella-zoster vaccine even in patients with underlying illnesses. A history of herpes zoster might be related to development of injection-site AEs in healthy adults.

trial registrationThe study was prospectively registered on Japic-Clinical Trials Information as JapicCTI-163415 on October 31, 2016.

Indexed as

AgedAged, 80 and overAutoimmune DiseasesChickenpoxChronic DiseaseComorbidityDiabetes MellitusFemaleHealthy VolunteersHerpesvirus 3, HumanHerpes ZosterHerpes Zoster VaccineHumansInjection Site ReactionJapanKidney DiseasesHerpes Zoster VaccineVaccines, AttenuatedAdverse eventsAutoimmune diseasesDiabetes mellitusHerpes zosterMalignancyReactogenicityRenal diseasesSafetyVaricella-zoster vaccine

Identifiers

PMID30691396
PMCPMC6350288
OpenAlexW2936138307

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.