scholarly journals Recombinant Zoster Vaccine (Shingrix) real-world effectiveness in the first two years post-licensure

2021 ◽  
Author(s):  
Hector S Izurieta ◽  
Xiyuan Wu ◽  
Richard Forshee ◽  
Yun Lu ◽  
Heng-Ming Sung ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Herpes Zoster ◽  
Real World ◽  
Postherpetic Neuralgia ◽  
Vaccine Effectiveness ◽  
Community Dwelling ◽  
Zoster Vaccine ◽  
Post Market ◽  
Recombinant Zoster Vaccine ◽  
Dose Vaccine

Abstract Background Shingrix™ (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as two doses given 2–6 months apart, among adults ages ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster,but post-market vaccine performance has not been evaluated. Efficacy of a single dose, delayed second dose, or among persons with autoimmune or general immunosuppressive conditions have also not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix. Methods We conducted a cohort study among vaccinated and unvaccinated Medicare Part D community dwelling beneficiaries ages >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance, and marginal structural models to estimate hazard ratios. Results We found a vaccine effectiveness of 70.1% (95% CI, 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for two and one doses, respectively. The two-dose vaccine effectiveness was not significantly lower for beneficiaries 80+ years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4-81.8). Conclusions This large real-world observational study of effectiveness of Shingrix demonstrates the benefit of completing the two-dose regimen. Second doses administered beyond the recommended 6 months did not impair vaccine effectiveness.Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.

scholarly journals The Adjuvanted Recombinant Zoster Vaccine in Adults Aged ≥65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine

2020 ◽  
Author(s):  
Alemnew F Dagnew ◽  
Nicola P Klein ◽  
Caroline Hervé ◽  
George Kalema ◽  
Emmanuel Di Paolo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Herpes Zoster ◽  
T Cell ◽  
Immune Responses ◽  
Cd4 T Cell ◽  
Zoster Vaccine ◽  
Glycoprotein E ◽  
Cell Responses ◽  
Recombinant Zoster Vaccine ◽  
Over Time

Abstract Background Efficacy of the live-attenuated herpes zoster (HZ) vaccine (ZVL) wanes substantially over time. We evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) in previous ZVL recipients. Methods Adults aged ≥65 years who were previously vaccinated with ZVL ≥5 years earlier (n = 215) were group-matched with ZVL-naive individuals (n = 215) and vaccinated with RZV. Glycoprotein E (gE)–specific humoral and cell-mediated immune responses and the correlation between them, polyfunctional gE-specific CD4 T-cell responses, safety, and confirmed HZ cases were assessed. Results Through 12 months after dose 2, anti-gE antibody concentrations, gE-specific CD4 T-cell frequencies, and activation marker profiles were similar between groups. Safety outcomes were also similar. No HZ episodes were confirmed. Conclusions RZV induced strong humoral and polyfunctional cell-mediated immune responses that persisted above prevaccination levels through 1 year after dose 2 in adults aged ≥65 years irrespective of previous ZVL vaccination. The RZV safety profile was not affected. Clinical Trials Registration NCT02581410.

scholarly journals Effectiveness of the recombinant zoster vaccine in adults aged 50 and older in the United States: a claims-based cohort study

2021 ◽  
Author(s):  
Yuwei Sun ◽  
Eric Kim ◽  
Christina L Kong ◽  
Benjamin F Arnold ◽  
Travis C Porco ◽  
...  
Keyword(s):  
Cohort Study ◽  
Herpes Zoster ◽  
Vaccine Coverage ◽  
The United States ◽  
Vaccine Effectiveness ◽  
Administrative Claims ◽  
Zoster Vaccine ◽  
Immunization Rates ◽  
History Of ◽  
Recombinant Zoster Vaccine

Abstract Background The recombinant zoster vaccine had over 90% efficacy in preventing herpes zoster in clinical trials. However, its effectiveness outside of a clinical trial setting has not been investigated. This study aimed to assess the effectiveness of the recombinant zoster vaccine in general practice. Methods A de-identified administrative claims database, the OptumLabs ® Data Warehouse, was used to conduct this retrospective cohort study to assess the effectiveness of the recombinant zoster vaccine against herpes zoster in non-immunocompromised, vaccine age-eligible individuals enrolled in the database for ≥365 days. Results A total of 4 769 819 adults were included in this study, with 173 745 (3.6%) adults receiving two valid doses of the recombinant zoster vaccine. The incidence rate of herpes zoster was 258.8 (95% CI: 230.0 to 289.4) cases per 100 000 person-years in vaccinated persons compared to 893.1 (95% CI: 886.2 to 900.0) in unvaccinated. Recombinant zoster vaccine effectiveness was 85.5% (95% CI: 83.5% to 87.3%) overall, with an effectiveness of 86.8% (95% CI: 84.6% to 88.7%) in individuals 50 to 79-years-old compared to 80.3% (95% CI: 75.1% to 84.3%) in individuals ages 80 and older. In patients with a history of live zoster vaccine within 5 years of study inclusion, vaccine effectiveness was 84.8% (95% CI: 75.3% to 90.7%). Conclusions Recombinant zoster vaccine effectiveness against herpes zoster was high in a real-world setting. Given the low vaccine coverage and high effectiveness, a major public health effort is needed to identify and address barriers to vaccination and increase immunization rates.

scholarly journals Recombinant zoster vaccine (Shingrix®): a new option for the prevention of herpes zoster and postherpetic neuralgia

2020 ◽  
Vol 33 (3) ◽  
pp. 201-207
Author(s):  
Grisuna Singh ◽  
Sejin Song ◽  
Eunjoo Choi ◽  
Pyung-Bok Lee ◽  
Francis Sahngun Nahm
Keyword(s):  
Herpes Zoster ◽  
Postherpetic Neuralgia ◽  
Zoster Vaccine ◽  
Recombinant Zoster Vaccine

Is herpes zoster vaccine safe and effective for preventing zoster and postherpetic neuralgia?

2015 ◽  
Vol 18 (9) ◽  
pp. 9-10
Author(s):  
Emily Colson ◽  
Aaron TenHarmsel ◽  
Michael D. Geurin
Keyword(s):  
Herpes Zoster ◽  
Postherpetic Neuralgia ◽  
Zoster Vaccine

scholarly journals Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination

2020 ◽  
Author(s):  
Andrew Hastie ◽  
Grégory Catteau ◽  
Adaora Enemuo ◽  
Tomas Mrkvan ◽  
Bruno Salaun ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Standard Deviation ◽  
Immune Responses ◽  
Primary Vaccination ◽  
Additional Dose ◽  
Zoster Vaccine ◽  
Anamnestic Response ◽  
Recombinant Zoster Vaccine

Abstract Background The adjuvanted recombinant zoster vaccine (RZV) is highly immunogenic and efficacious in adults ≥50 years of age. We evaluated (1) long-term immunogenicity of an initial 2-dose RZV schedule, by following up adults vaccinated at ≥60 years of age and by modeling, and (2) immunogenicity of 2 additional doses administered 10 years after initial vaccination. Methods Persistence of humoral and cell-mediated immune (CMI) responses to 2 initial RZV doses was assessed through 10 years after initial vaccination, and modeled through 20 years using a Piecewise, Power law and Fraser model. The immunogenicity and safety of 2 additional RZV doses were also evaluated. Results Seventy adults were enrolled. Ten years after initial vaccination, humoral and CMI responses were approximately 6-fold and 3.5-fold, respectively, above those before the initial vaccination levels. Predicted immune persistence through 20 years after initial vaccination was similar across the 3 models. Sixty-two participants (mean age [standard deviation], 82.6 [4.4] years) received ≥1 additional RZV dose. Strong anamnestic humoral and CMI responses were elicited by 1 additional dose, without further increases after a second additional dose. Conclusions Immune responses to an initial 2-dose RZV course persisted for many years in older adults. Strong anamnestic immune responses can be induced by additional dosing 10 years after the initial 2-dose course. Clinical Trials Registration NCT02735915.

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