Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention

Lecrenier, Nicolas; Beukelaers, Pierre; Colindres, Rómulo E.; Curran, Desmond; Kesel, C. De; Saegher, Jean Philippe De; Didierlaurent, Arnaud M.; Ledent, Edouard; Mols, Johann; Mrkvan, Tomáš; Normand‐Bayle, Marie; Oostvogels, Lidia; Silva, Fernanda Tavares Da; Vassilev, Ventzislav; Vinals, Carlota; Brecx, Alain

doi:10.1080/14760584.2018.1495565

Cited by 86 publications

(73 citation statements)

References 99 publications

(136 reference statements)

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“…8,9 An adjuvanted recombinant zoster vaccine, consisting of the varicella-zoster virus glycoprotein E antigen and the AS01 B adjuvant system, is nonlive and has no associated risk of triggering the infection in healthy adults. 10 This vaccine significantly reduced herpes zoster risk in adults aged at least 50 and at least 70 years (vaccine efficacy, 91%) and has been licensed in several countries. 11,12 Because the immune system is immature after stem cell infusion and intensive conditioning regimens given before HSCT, patients cannot mount an adequate protective immune response to vaccines given shortly after transplantation.…”

mentioning

confidence: 99%

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation

Bastidas

Serna

Idrissi

et al. 2019

JAMA

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182

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IMPORTANCEHerpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster.OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients.DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT.INTERVENTIONS Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. MAIN OUTCOMES AND MEASURESThe primary end point was occurrence of confirmed herpes zoster cases. RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P < .001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points. CONCLUSIONS AND RELEVANCE Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months.

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mentioning

confidence: 99%

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation

Bastidas

Serna

Idrissi

et al. 2019

JAMA

Self Cite

182

174

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“…The two-dose adjuvanted subunit inactivated HZ vaccine is currently on the market in the USA, Australia, and Canada. The efficacy of this inactivated vaccine against HZ and PHN was >90% and 89% compared to placebo in subjects aged 50+ and 70+ years [61]. The vaccine is not contraindicated in immunocompromised individuals, and is preferred, in the United States, over the live attenuated HZ vaccine in immunocompetent individuals [62].…”

Section: Discussionmentioning

confidence: 97%

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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“…7,8 RZV also demonstrated an acceptable safety profile. 7,8,10 It is currently licensed in multiple countries for the prevention of HZ in adults ≥50 YOA.…”

Section: Introductionmentioning

confidence: 99%

Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials

Oostvogels

Heineman²,

Johnson

et al. 2019

Human Vaccines & Immunotherapeutics

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In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4–97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3–99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.

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Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention

Cited by 86 publications

References 99 publications

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation

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

Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials

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