Faculty Opinions recommendation of Herpes zoster vaccine effectiveness against incident herpes zoster and post-herpetic neuralgia in an older US population: a cohort study.

Author(s):  
Hywel Williams
Author(s):  
Yuwei Sun ◽  
Eric Kim ◽  
Christina L Kong ◽  
Benjamin F Arnold ◽  
Travis C Porco ◽  
...  

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.


Author(s):  
Hector S Izurieta ◽  
Xiyuan Wu ◽  
Richard Forshee ◽  
Yun Lu ◽  
Heng-Ming Sung ◽  
...  

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.


2015 ◽  
Vol 2 (suppl_1) ◽  
Author(s):  
Hung Fu Tseng ◽  
Yi Luo ◽  
Craig Hales ◽  
Stephanie R. Bialek ◽  
Rafael Harpaz ◽  
...  

2018 ◽  
Vol 79 (4) ◽  
pp. 527-533 ◽  
Author(s):  
Kellie L. Hawkins ◽  
Kirsha S. Gordon ◽  
Myron J. Levin ◽  
Adriana Weinberg ◽  
Catherine Battaglia ◽  
...  

2015 ◽  
Vol 11 (5) ◽  
pp. 1157-1164 ◽  
Author(s):  
Mona Marin ◽  
Barbara P Yawn ◽  
Craig M Hales ◽  
Peter C Wollan ◽  
Stephanie R Bialek ◽  
...  

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S413-S413
Author(s):  
Brandon J Patterson ◽  
Philip O Buck ◽  
Justin Carrico ◽  
Katherine A Hicks ◽  
Desmond Curran ◽  
...  

Abstract Background Herpes zoster (HZ), commonly referred to as shingles, is a reactivation of latent varicella zoster virus in patients previously infected. Clinical characteristics of HZ include painful rash with potential complications, including post herpetic neuralgia (PHN). Care for HZ and PHN incurs significant costs and vaccination is beneficial. The aim of this study was to compare the impact on HZ and PHN case avoidance of two HZ vaccines, an available live-attenuated zoster vaccine (zoster vaccine live [ZVL]) vs. a candidate non-live adjuvanted HZ subunit vaccine (HZ/su), in the US population. Methods A Markov model called ZONA (ZOster ecoNomic Analyses) was developed following two age cohorts (≥60 years to represent the current ACIP recommendation and ≥65 years to represent the Medicare population) over their lifetimes from the year of vaccination. Demographic data were obtained from the US Census, whereas HZ incidence and the proportion of HZ individuals developing PHN were derived from published US-specific sources. Age-specific vaccine efficacy and waning rates were based on published clinical trial data. Vaccine coverage for both vaccines was assumed to be 30.6% and 34.2% in the two age cohorts, respectively, based on CDC data; compliance of the second dose of the HZ/su vaccine was 69%, based on data from clinical trials and Hepatitis B seconddose completion. Sensitivity analyses demonstrated robustness of the base analysis findings. Results In the US, for cohorts of 66.83 million (M) persons aged 60+ and 47.76M aged 65+ it was estimated that the HZ/su vaccine would reduce the number of HZ cases by 2.12M and 1.55M in the two age cohorts, respectively, compared with 0.65M and 0.45M using the ZVL. Furthermore, the HZ/su vaccine would reduce the number of PHN cases by 0.23M and 0.18M in the two age cohorts, respectively, compared with 0.10M and 0.09 using the ZVL. The number needed to vaccinate to prevent one HZ case were 10 and 11, in the respective cohorts, using the HZ/su vaccine compared with 31 and 37, in the respective cohorts, using the ZVL. Conclusion Due to higher and sustained vaccine efficacy, the candidate HZ/su vaccine demonstrated superior public health impact in the US compared with the currently available ZVL. Disclosures B. J. Patterson, GSK: Employee and Shareholder, GSK stock options or restricted shares and Salary; Pennsylvania Pharmacists Association: Scientific Advisor, stipend; P. O. Buck, GSK: Employee and Shareholder, GSK stock options or restricted shares and Salary; J. Carrico, RTI Health Solutions: Employee, Salary GSK: Research Contractor, Research support; K. A. Hicks, RTI: Employee, Salary GSK: Research Contractor, Research support; D. Curran, GSK: Employee and Shareholder, GSK stock options or restricted shares and Salary; D. Van Oorschot, GSK: Employee, Salary; J. E. Pawlowski, GSK: Employee and Shareholder, GSK stock options or restricted shares and Salary; B. Y. Lee, GSK: Consultant, Consulting fee; B. P. Yawn, GSK: Consultant and Scientific Advisor, Consulting fee


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