Efficacy and safety of live varicella zoster vaccine in diabetes: a randomized, double‐blind, placebo‐controlled trial

Hata, Atsuko; Inoue, Fukue; Hamamoto, Yoshiyuki; Yamasaki, Midori; Fujikawa, Jun; Kawahara, Hiroyuki; Kawasaki, Yukiko; Honjo, Sachiko; Koshiyama, Hiroyuki; Moriishi, Eiko; Mori, Yasuko

doi:10.1111/dme.13038

Cited by 16 publications

(9 citation statements)

References 24 publications

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“…After screening 2037 titles and abstracts and 175 full text articles, 27 studies 10 11 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 providing data on 2 044 504 patients, and 18 companion reports, 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 met the eligibility criteria ( fig 1 ). Twenty two studies 10 11 52 53 54 55 56 60 61 62 63 64 65 66 67 68 70 71 72 73 76 95 were included in the statistical analysis. The remaining five studies 57 58 59 74 75 compared the same vaccine by routes of vaccination, handling of the vaccines, storage of the vaccines, or by time between doses (see summary ...…”

Section: Resultsmentioning

confidence: 99%

Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis

Tricco

Zarin

Cardoso

et al. 2018

BMJ

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ObjectiveTo compare the efficacy, effectiveness, and safety of the herpes zoster live attenuated vaccine with the herpes zoster adjuvant recombinant subunit vaccine or placebo for adults aged 50 and older.DesignSystematic review with bayesian meta-analysis and network meta-analysis.Data sourcesMedline, Embase, and Cochrane Library (inception to January 2017), grey literature, and reference lists of included studies.Eligibility criteria for study selectionExperimental, quasi-experimental, and observational studies that compared the live attenuated vaccine with the adjuvant recombinant subunit vaccine, placebo, or no vaccine in adults aged 50 and older. Relevant outcomes were incidence of herpes zoster (primary outcome), herpes zoster ophthalmicus, post-herpetic neuralgia, quality of life, adverse events, and death.Results27 studies (22 randomised controlled trials) including 2 044 504 patients, along with 18 companion reports, were included after screening 2037 titles and abstracts, followed by 175 full text articles. Network meta-analysis of five randomised controlled trials found no statistically significant differences between the live attenuated vaccine and placebo for incidence of laboratory confirmed herpes zoster. The adjuvant recombinant subunit vaccine, however, was statistically superior to both the live attenuated vaccine (vaccine efficacy 85%, 95% credible interval 31% to 98%) and placebo (94%, 79% to 98%). Network meta-analysis of 11 randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more adverse events at injection sites than the live attenuated vaccine (relative risk 1.79, 95% credible interval 1.05 to 2.34; risk difference 30%, 95% credible interval 2% to 51%) and placebo (5.63, 3.57 to 7.29 and 53%, 30% to 73%, respectively). Network meta-analysis of nine randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more systemic adverse events than placebo (2.28, 1.45 to 3.65 and 20%, 6% to 40%, respectively).ConclusionsUsing the adjuvant recombinant subunit vaccine might prevent more cases of herpes zoster than using the live attenuated vaccine, but the adjuvant recombinant subunit vaccine also carries a greater risk of adverse events at injection sites.Protocol registrationProspero CRD42017056389.

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Section: Resultsmentioning

confidence: 99%

Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis

Tricco

Zarin

Cardoso

et al. 2018

BMJ

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“…In another placebo-controlled study from Japan, the same VZV vaccine was co-administered with the 23-valent pneumococcal polysaccharide vaccine in 60–70-year-old patients with DM. The VZV vaccine did not enhance either humoral or cell-mediated VZV-specific immunity more than placebo [ 43 ]. Admittedly, the small study sample, the short follow-up period and the use of a different VZV vaccine are important limitations of the above-mentioned studies.…”

Section: Preventionmentioning

confidence: 99%

Herpes Zoster and Diabetes Mellitus: A Review

2018

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Accumulating evidence suggests that diabetes mellitus (DM) represents an important risk factor for both herpes zoster and post-herpetic neuralgia. Moreover, post-herpetic neuralgia appears to be more severe and persistent in diabetic patients. On the other hand, a novel vaccine against varicella-zoster virus (VZV) was recently introduced in clinical practice. Given the increased risk and severity of herpes zoster infection in patients with DM, this vaccine might be useful in this population. However, there are limited data regarding the efficacy and safety of vaccination against herpes zoster in the diabetic population. The aim of the present review is to discuss the incidence and consequences of herpes zoster infection in DM and to comment on the role of vaccination against VZV in these patients.

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“…The effectiveness of the liveattenuated vaccine did not differ between patients with diabetic nephropathy and the general population [56]. In two other small-scale studies in Japan, the live-attenuated HZ vaccine was safe in patients with diabetes and enhanced the immunity to VZV [63,64]. Tseng and collaborators investigated the efficacy of the live-attenuated HZ vaccine in a subgroup of 14,720 vaccinated and 50,212 unvaccinated patients with diabetes [65].…”

Section: Discussionmentioning

confidence: 99%

Diabetes as a risk factor for herpes zoster in adults: A synthetic literature review

Saadatian‐Elahi

Bauduceau

Del-Signore

et al. 2020

Diabetes Research and Clinical Practice

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Efficacy and safety of live varicella zoster vaccine in diabetes: a randomized, double‐blind, placebo‐controlled trial

Cited by 16 publications

References 24 publications

Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis

Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis

Herpes Zoster and Diabetes Mellitus: A Review

Diabetes as a risk factor for herpes zoster in adults: A synthetic literature review

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