Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials

Willer, David O.; Oostvogels, Lidia; Cunningham, Anthony L.; Gervais, Pierre; Gorfinkel, Iris; Kim, Joon Hyung; Talarico, Carla; Wascotte, Valentine; Zahaf, Toufik; Colindres, Rómulo E.; Schuind, Anne; Ahonen, Anitta; Andrews, Charles P.; Athan, Eugene; Avelino‐Silva, Thiago Junqueira; Barba-Gomez, Jose-Fernando; Berglund, Johan; Cuixart, Carles Brotons; Caso, Covadonga; Chlíbek, Roman; Choi, Won Suk; Looze, Ferdinandus de; Desole, Maria Giuseppina; Díez-Domingo, Javier; Downey, Jackson; Eizenberg, Peter; Esen, Meral; Ghesquière, Wayne; Hui, David Shu Cheong; Hwang, Shinn‐Jang; Ikematsu, Hideyuki; Johnson, Robert W.; Korhonen, Tiina; Leung, Edward M. F.; Levin, Myron J.; Santos, Abiel Mascareñas de los; McElhaney, Janet E.; McNeil, Shelly; Pérez, Silvia Narejos; Pauksens, Karlis; Pellegrino, Angelo; Põder, Airi; Puig-Barberà, Joan; Santos, Rinaldo Cardoso dos; Pinta, María Luisa Rodriguez de la; Rombo, Lars; Schwarz, Tino F.; Seppa, Ilkka; Smetana, Jan; Staniscia, Tommaso; Thompson, Alexander; Tinoco, Juan Carlos; Toma, Aurel; Watanabe, Daisuke; Weckx, Lily; Yeo, Wilfred

doi:10.1016/j.vaccine.2019.09.028

Cited by 22 publications

(17 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…There was a trend for incidence rates to be lower in Europe followed by North America, Asia and Oceania in this analysis of data synthesized from many studies with much heterogeneity in study methodology and outcomes. However, the same trend was observed in the placebo groups of two large randomized clinical trials of a HZ vaccine, where the case definition and study methodology were consistent across all study participants and continents [ 40 ].…”

Section: Discussionmentioning

confidence: 59%

Meta-Regression of Herpes Zoster Incidence Worldwide

et al. 2021

View full text Add to dashboard Cite

Introduction Many studies have been conducted worldwide to estimate herpes zoster (HZ) incidence rates. We synthesized studies of HZ incidence rates in the general population using meta-analysis models. Methods A random effects meta-analysis was conducted to estimate HZ incidence from a published worldwide systematic literature review (SLR) including only individuals aged 50 years and older. Meta-regression was used to explore whether variability in incidence rates could be explained by a combination of study-specific characteristics including age, gender, continent and year of study data. The impact of adding additional covariates—case detection method (general practitioner surveillance, healthcare database, sentinel network, etc.), case definition (medical record-based, self-reported), study design (retrospective passive surveillance, retrospective active surveillance, etc.), incidence type (cumulative incidence/1000 persons or incidence rate/1000 person-years), patient type (outpatients or in- and out-patients) and latitude to the base model—was also assessed. Results Sixty-one records from 59 studies were included in the analysis: 25, 20, 11 and 5 from Europe, North America, Asia and Oceania, respectively. There was variation in study methodology and outcomes. Heterogeneity of incidence rates was greatest among studies conducted in Asia. Meta-analysis showed that incidence increased with age, was lower in males compared to females, tended to be lower in Europe and North America compared to Asia and Oceania and increased with year of study data. The data-driven meta-regression model included continent, year of study data, gender, age and an age × gender interaction term. The difference in incidence between males and females was greater in younger ages (e.g., 50–59) compared to older age groups (e.g., 80+). None of the additional covariates contributed significantly to the model. Conclusion Incidence rates were shown to vary by age, gender, continent and year of study data. Graphical Plain Language Summary Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00567-8.

show abstract

Section: Discussionmentioning

confidence: 59%

Meta-Regression of Herpes Zoster Incidence Worldwide

et al. 2021

View full text Add to dashboard Cite

show abstract

“…The lack of an age effect with RZV on herpes zoster and post-herpetic neuralgia is important, as the incidence and severity of both increases markedly with age in unvaccinated populations. Although the incidence of herpes zoster has been reported to differ across gender and racial groups,58 no such differences were observed in the efficacy of RZV 59…”

Section: Vaccines For Herpes Zostermentioning

confidence: 99%

Vaccines for older adults

Cunningham

McIntyre

Subbarao

et al. 2021

BMJ

View full text Add to dashboard Cite

The proportion of the global population aged 65 and older is rapidly increasing. Infections in this age group, most recently with SARS-CoV-2, cause substantial morbidity and mortality. Major improvements have been made in vaccines for older people, either through the addition of novel adjuvants—as in the new recombinant zoster vaccine and an adjuvanted influenza vaccine—or by increasing antigen concentration, as in influenza vaccines. In this article we review improvements in immunization for the three most important vaccine preventable diseases of aging. The recombinant zoster vaccine has an efficacy of 90% that is minimally affected by the age of the person being vaccinated and persists for more than four years. Increasing antigen dose or inclusion of adjuvant has improved the immunogenicity of influenza vaccines in older adults, although the relative effectiveness of the enhanced influenza vaccines and the durability of the immune response are the focus of ongoing clinical trials. Conjugate and polysaccharide pneumococcal vaccines have similar efficacy against invasive pneumococcal disease and pneumococcal pneumonia caused by vaccine serotypes in older adults. Their relative value varies by setting, depending on the prevalence of vaccine serotypes, largely related to conjugate vaccine coverage in children. Improved efficacy will increase public confidence and uptake of these vaccines. Co-administration of these vaccines is feasible and important for maximal uptake in older people. Development of new vaccine platforms has accelerated following the arrival of SARS-CoV-2, and will likely result in new vaccines against other pathogens in the future.

show abstract

“…Other recently published post-hoc analyses of data from the ZOE-50/70 trials demonstrated no impact of geographic ancestry/ethnicity, region, sex, or underlying medical conditions at enrollment on efficacy of RZV. 15 , 27 , 28 VE against HZ was 97.2% (95% CI: 91.4–99.5) in Europe, 96.1% (95% CI: 88.2–99.3) in Asia/Australia, 95.7% (95% CI: 83.7–100) in North America, and 96.3% (95% CI: 77.2–100) in Latin America in the ≥50-year-olds from the ZOE-50 study and 90.1% (95% CI: 82.0–95.1) in Europe, 95.1% (95% CI: 87.0–98.7) in Asia/Australia, 90.1% (95% CI: 77.0–96.5) in North America, and 87.3% (95% CI: 58.1–97.6) in Latin America among the ≥70-year-olds from the ZOE-50/70 studies. 15 Additionally, RZV vaccination reduced the loss of quality of life associated with both HZ and PHN and alleviated the severity of HZ-related pain in breakthrough HZ episodes.…”

Section: Discussionmentioning

confidence: 99%

“… 13 , 14 The vaccine appeared efficacious against HZ and PHN irrespective of sex, region, or geographic ancestry/ethnicity. 15 In several countries worldwide, RZV is currently licensed and recommended for the prevention of HZ and, in some cases, PHN in adults ≥50 YOA. 16 , 17 In Asia, RZV was approved in Japan (2018) and China (2019) for the prevention of HZ in adults ≥50 YOA.…”

Section: Introductionmentioning

confidence: 99%

The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials

Kim

Diaz-Decaro

Jiang

et al. 2021

Human Vaccines & Immunotherapeutics

Self Cite

View full text Add to dashboard Cite

In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy (VE) against herpes zoster (HZ) in adults ≥50 years of age (YOA). This post-hoc analysis assessed the VE against HZ and postherpetic neuralgia (PHN), in participants from Asian study sites enrolled in ZOE-50/70. Reactogenicity and safety were also assessed. Participants ≥50 YOA were randomized 1:1 to receive 2 doses of either RZV or placebo, 2 months apart. VE was evaluated for a median follow-up of 4 years post-vaccination overall and by age in the ZOE-50 Asian population ≥50 YOA and in the pooled ZOE-50/70 Asian population ≥70 YOA. Of the 2,729 participants included in the ZOE-50 Asian population ≥50 YOA, 3 RZV and 66 placebo recipients reported a confirmed HZ episode. Overall VE was 95.6% (95% confidence interval [CI]: 86.4–99.1) against HZ and 100% (95% CI: 35.44–100) against PHN. In the pooled ZOE-50/70 Asian population ≥70 YOA, 4 RZV and 75 placebo recipients out of the 2,723 participants reported a confirmed HZ episode. Overall VE was 94.7% (95% CI: 85.9–98.6) against HZ and 89.8% (95% CI: 28.39–99.77) against PHN. Pain and myalgia were the most frequent solicited local and general adverse events, respectively, in both populations. No safety concern was identified during the study periods. RZV is highly efficacious against HZ and PHN and has an acceptable safety profile in Asian populations ≥50 YOA, similar to what was observed in the general ZOE-50/70 populations. Trademark statement : Shingrix is a trademark owned by or licensed to the GSK group of companies.

show abstract

Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials

Cited by 22 publications

References 12 publications

Meta-Regression of Herpes Zoster Incidence Worldwide

Meta-Regression of Herpes Zoster Incidence Worldwide

Vaccines for older adults

The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials

Contact Info

Product

Resources

About