Adjuvanted Herpes Zoster Subunit Vaccine Research Articles

Immunogenicity, reactogenicity, and safety of two-dose adjuvanted herpes zoster subunit vaccine in patients with systemic lupus erythematosus in South Korea: a single-centre, randomised, double-blind, placebo-controlled trial

The adjuvanted herpes zoster subunit vaccine has shown good efficacy and safety in the general population. However, its effectiveness has not been comprehensively assessed in patients with systemic lupus erythematosus (SLE). This study aimed to evaluate the immunogenicity and safety of the adjuvanted herpes zoster subunit vaccine in patients with SLE. This single-centre, randomised, double-blind, placebo-controlled, trial was done at the rheumatology outpatient clinic at Seoul National University Hospital, South Korea. Patients (aged ≥19 years) with clinically stable SLE and previous exposure (≥4 weeks) to immunosuppressive drugs were randomly assigned (4:1) via a central interactive web response system to receive herpes zoster subunit vaccine or placebo (0·5 mL intramuscular injection) at weeks 0 and 8. Investigators and participants were masked to intervention and group assignment. Anti-glycoprotein E antibody titres and glycoprotein E-specific cell-mediated vaccine responses were evaluated at baseline and at week 8 after the first dose, and at week 4, week 26, and week 52 after the second dose using enzyme-linked immunosorbent assay and flow cytometry, respectively. Reactogenicity, SLE disease activity, including Systemic Lupus Erythematosus Disease Activity Index 2000 and British Isles Lupus Assessment Group-flare rate, were examined. The primary outcome was the proportion of patients with a positive humoral vaccine response 4 weeks after the second dose. The primary and safety analyses were done in a modified intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT06001606. Between June 14, and July 19, 2023, 65 patients with SLE were enrolled, of whom 52 were randomly assigned to the herpes zoster subunit vaccine and 13 to placebo. 49 patients in the vaccine group and 11 patients in the placebo group were included in the modified intention-to-treat population. 56 (93%) of 60 patients were women and four (7%) were men. Mean age was 48·7 years (SD 11·4). The proportion of participants with a humoral vaccine response at 4 weeks after the second dose was significantly higher in the vaccine group (48 [98%] of 49 participants) than the placebo group (none [0%] of 11 patients; p<0·0001). More patients in the vaccine group than placebo group reported injection site reactions (42 patients vs two patients), fever (ten vs none), and fatigue (26 vs two). There were no differences in Systemic Lupus Erythematosus Disease Activity Index 2000 and British Isles Lupus Assessment Group-flare rates between the groups. There were no treatment-related deaths. The herpes zoster subunit vaccine induces humoral and cellular immunity against herpes zoster with a good safety profile in patients with SLE. A larger study is warranted to assess the efficacy of vaccines to prevent herpes zoster in patients with SLE. Ministry of Science and ICT, The Government of the Republic of Korea.

Vacunación frente al virus del herpes zóster

ObjectiveTo review the latest published evidence on the vaccine used in our country against the herpes zoster virus, breaking down the results according to the efficacy, efficiency, effectiveness and safety of the vaccine. Include the current recommendations for vaccination. DesignSecondary review. Descriptive qualitative review. Review using the search term “herpes zoster vaccine” and “Adjuvanted recombinant Herpes Zoster subunit vaccine”. Retrospective observational study. Data sourcesEmbase, Medline and Google Scholar.Selection of studies Search criterion with the terms “Shingrix vaccine” and “Adjuvanted Herpes Zoster Subunit Vaccine”. Search period 2013-2023. Studies classified as clinical trials or randomized clinical trials were selected. 21 published studies were evaluated. There were no exclusions. ResultsThe evaluated studies were found to be coherent and in all of them efficacy in adult individuals in preventing viral reactivation and in preventing complications was higher than 80%. The effectiveness of the vaccine after two doses was also higher than 80%. Cost-effectiveness studies were always favourable in adults, immunodepressed patients and individuals with chronic pathology. The safety of the vaccine was evaluated in the pivotal studies and in the post-commercialization studies that were undertaken (although there were few of the latter due to the short period of time studied). The safety profile of the vaccine is very high and in the case of severe adverse effects, their frequency was similar to that of a placebo. ConclusionsWe have a safe and effective vaccine against the herpes zoster virus that allows us to protect the most vulnerable population groups against this virus.

Vaccination in older adults: compulsory or voluntary exercise?

Immunosenescence leads to an increasing susceptibility to infections. Therefore, vaccination is an essential element of prevention. The recommendations of the permanent vaccination commission (STIKO), a committee at the Robert-Koch-Institute, affiliated to the German Government, are updated every year and include a particular section dealing with older adults. Immunosenescence reduces vaccine effectiveness. Thus, older adults and patients with multimorbidity are in need of more immunogenic vaccines. Cell culture derived quadrivalent influenza vaccine, trivalent adjuvanted vaccine and a high dose influenza vaccine show higher immune response in these groups. STIKO actually recommends an adjuvanted herpes zoster subunit vaccine to all adults in the age of 60 and above because of its vaccine effectiveness of 90 % in all age groups. The increasing travel activities of older adults require travel vaccination advice that takes into account travel destination as well as multimorbidity. Adjusted vaccination schedules and controlling of antibody titers have to be considered. New vaccines are under development, that are more immunogenic and therefore more effective (e. g. pneumococcal vaccine) or that prevent infections for which a vaccine was previously not available (e. g. norovirus vaccine).

Underimmunization of the solid organ transplant population: An urgent problem with potential digital health solutions.

Solid organ transplant recipients are at risk for potentially life-threatening infections due to lifelong immunosuppression. Vaccine-preventable infections result in graft injury, morbidity, mortality, and significantly increased medical costs. Unfortunately, the majority of transplant recipients continue to be underimmunized at the time of transplant and thereafter. Given the rising rates of vaccine hesitancy and refusal in the general population, transplant recipients can no longer rely on herd immunity to protect them from vaccine-preventable infections. Novel tools are desperately needed to overcome transplant-specific immunization barriers to improve immunization rates in this high-risk population. Digital health technologies may offer a solution by addressing transplant-specific barriers: specifically, providing accurate information about vaccine safety, efficacy, and timing in the pre- and posttransplant periods; making a complete immunization record universally available and easily accessible; enabling communication between patients and multiple providers; and providing automated vaccine reminders to both patients and providers when vaccines are due using transplant-specific immunization guidelines. Digital health has transformed health care by empowering patients with their own health information and connecting patients, their providers, and public health officials. In doing so, it offers a potential platform to address and overcome the problem of underimmunization in the transplant population.

Optimal gender-specific age for cost-effective vaccination with adjuvanted herpes zoster subunit vaccine in Chinese adults.

BackgroundAdjuvanted herpes zoster (HZ) subunit (HZ/su) vaccine is recommended for healthy adults aged ≥50 years, yet vaccine efficacy is expected to wane over time. Age-sex specific cost-effectiveness analyses of HZ/su vaccine are warranted to inform decision-making on vaccine policy. We aimed to determine the optimal gender-specific age for cost-effective HZ/su vaccination in Hong Kong.MethodsA Markov model was used to compare outcomes with and without HZ/su in healthy males and females at age 50–80 years. Model outcome measures were total cost, HZ cases, and HZ-associated quality-adjusted life-years (QALYs) loss. Incremental cost per QALY saved (ICER) by HZ/su was estimated for each age-sex group. Sensitivity analyses were performed to examine robustness of model results.ResultsHZ/su reduced incidence of HZ in both males and females aged 50–80 years and the numbers needed to vaccinate to avoid one HZ case were lowest at age 60 years for males (6.05) and females (5.50). The highest QALY-saved occurred in females (0.00396 QALYs) and males (0.00379 QALYs) who were vaccinated at 60 years old. The ICERs were lowest at age 60–70 years for both genders. Using 1× gross domestic product per capita of Hong Kong (USD46,153) as willingness-to-pay threshold, HZ/su vaccine was accepted to be cost-effective for all female and male age groups at vaccine cost = USD160, for female aged 50–79 years and male aged 54–74 years at vaccine cost = USD200, and for female aged 59–71 years at vaccine cost = USD240.ConclusionsHZ/su vaccine is more likely to be cost-effective for males and females aged between 60–70 years than the extreme age groups (less than 60 years and older than 70 years) in Hong Kong. The age range for cost-effective acceptance of HZ/su vaccine appears to be broader in females than males given the same vaccine cost and willingness-to-pay threshold.

Cost-effectiveness of vaccination of immunocompetent older adults against herpes zoster in the Netherlands: a comparison between the adjuvanted subunit and live-attenuated vaccines

BackgroundThe newly registered adjuvanted herpes zoster subunit vaccine (HZ/su) has a higher efficacy than the available live-attenuated vaccine (ZVL). National decision-makers soon need to decide whether to introduce HZ/su or to prefer HZ/su above ZVL.MethodsUsing a Markov model with a decision tree, we conducted a cost-effectiveness analysis of vaccination with HZ/su (two doses within 2 months) or zoster vaccine live (ZVL) (single dose, or single dose with a booster after 10 years) for cohorts of 50-, 60-, 70- or 80-year-olds in the Netherlands. The model was parameterized using vaccine efficacy data from randomized clinical trials and up-to-date incidence, costs and health-related quality of life data from national datasets. We used a time horizon of 15 years, and the analysis was conducted from the societal perspective.ResultsAt a coverage of 50%, vaccination with two doses of HZ/su was estimated to prevent 4335 to 10,896 HZ cases, depending on the cohort age. In comparison, this reduction was estimated at 400–4877 for ZVL and 427–6466 for ZVL with a booster. The maximum vaccine cost per series of HZ/su to remain cost-effective to a willingness-to-pay threshold of €20,000 per quality-adjusted life year (QALY) gained ranged from €109.09 for 70-year-olds to €63.68 for 50-year-olds. The cost-effectiveness of ZVL changed considerably by age, with corresponding maximum vaccine cost per dose ranging from €51.37 for 60-year-olds to €0.73 for 80-year-olds. Adding a ZVL booster after 10 years would require a substantial reduction of the maximum cost per dose to remain cost-effective as compared to ZVL single dose. Sensitivity analyses on the vaccine cost demonstrated that there were scenarios in which vaccination with either HZ/su (two doses), ZVL single dose or ZVL + booster could be the most cost-effective strategy.ConclusionsA strategy with two doses of HZ/su was superior in reducing the burden of HZ as compared to a single dose or single dose + booster of ZVL. Both vaccines could potentially be cost-effective to a conventional Dutch willingness-to-pay threshold for preventive interventions. However, whether HZ/su or ZVL would be the most cost-effective alternative depends largely on the vaccine cost.

A novel nonlive, adjuvanted herpes zoster subunit vaccine: a report on the emerging clinical data and safety profile.

Herpes zoster (HZ) is an acute vesicular dermatitis with a typical dermatomal distribution, caused by the varicella zoster virus (VZV), often preceded and accompanied by prodromal pain or pruritus. HZ may be related to several complications such as postherpetic neuralgia (PHN). The incidence and severity of the disease increase with aging, due to immunosenescence and in particular to the decline of the specific cell-mediated immunity (CMI). The impact of HZ in terms of morbidity and short- and long-term complications, the availability of suboptimal treatment options to date, and the high costs for the diagnostic and clinical-therapeutic management of patients have motivated the search for a new preventive approach through the development of a vaccine. The vaccine currently in use with live-attenuated virus (ZVL) has been shown to be effective in reducing the incidence of HZ, its impact, and the onset of PHN, although the efficacy is lower in older subjects and tends to decrease some years after immunization. A new adjuvanted recombinant subunit vaccine (HZ/su), containing the VZV glycoprotein E (gE) and the AS01B adjuvant system, is now a very promising alternative to ZVL; in several clinical studies, it showed a good safety profile and was able to elicit high immune humoral and cell-mediated responses, both maintained up to 9 years. Furthermore, HZ/su vaccine was effective both in preventing HZ and in reducing the onset of PHN and other complications. HZ/su has been recommended and preferred over ZVL by the Advisory Committee on Immunization Practices (ACIP) for the prevention of HZ and its complications in immunocompetent adults aged ≥50 years, even if already vaccinated with ZVL, through a two-dose schedule. HZ/su has been approved in Canada, USA, Europe, and Japan and is currently being approved in Australia. The aim of this review was to describe the epidemiological data, HZ and PHN risks and their impact on the social life and common life of infected people, and ZVL and HZ/su vaccine development including various clinical trials and efficacy, safety, and tolerability profiles.

Potential cost-effectiveness of adjuvanted herpes zoster subunit vaccine for older adults in Hong Kong

BackgroundAdjuvanted herpes zoster (HZ) subunit vaccine is recommended for adults aged ≥50 years. This study aimed to investigate cost-effectiveness of HZ subunit vaccine for older adults at different age in Hong Kong. MethodsA life-long Markov model was designed to simulate outcomes of four alternatives: Vaccination at model entry (age 50 years); deferring vaccination to 60 years; deferring vaccination to 70 years; and no vaccination. Outcome measures included direct cost, indirect cost, HZ and post-herpetic neuralgia incidences, quality-adjusted life years (QALYs) loss, and incremental cost per QALY saved (ICER). Model clinical inputs were derived from literature. HZ treatment costs were collected from a cohort of HZ patients (n = 218). One-way and probabilistic sensitivity analyses were performed. ResultsIn base-case analysis, vaccination at 50 years showed highest QALYs saved and increment cost (0.00258; USD166), followed by deferring to 60 years (0.00215 QALYs saved; USD102) and deferring to 70 years (0.00134 QALYs; USD62) when comparing to no vaccination. ICERs of vaccination arms versus no vaccine (46,267–64,341 USD/QALY) were between 1–3 × gross domestic product (GPD) per capita in Hong Kong (USD43,530–USD130,590). One-way sensitivity analyses found vaccine cost to be the common and most influential parameter for ICER of each vaccination strategy to become <1 × GDP per capita. In probabilistic sensitivity analysis, vaccination at 50 years, deferring to 60 years and 70 years were accepted as cost-effective in 90% of time at willingness-to-pay (WTP) of 78,400 USD/QALY, 57,680 USD/QALY and 53,760 USD/QALY, respectively. ConclusionsCost-effectiveness of each strategy is highly subject to the vaccine cost and WTP threshold per QALY saved.

Adjuvanted Herpes Zoster Subunit Vaccine Appears Cost-Effective Compared with Live Vaccine

The adjuvanted herpes zoster subunit vaccine (Shingrix) has superior efficacy compared with the live vaccine (Zostavax), and the Advisory Council on

Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials

BackgroundAn adjuvanted herpes zoster (HZ) subunit vaccine, HZ/su, demonstrated high efficacy against HZ and postherpetic neuralgia (PHN) in two randomized, observer-blind, placebo-controlled trials in adults aged ≥50 and ≥70 years (ZOE-50 and ZOE-70, respectively). MethodsData from ZOE-50 and ZOE-70 trials were analyzed to evaluate the efficacy of HZ/su against mortality, hospitalizations, and non-PHN complications of HZ including HZ-associated vasculitis, stroke, and disseminated, ophthalmic, neurologic, and visceral diseases. ResultsIn the pooled ZOE-50/ZOE-70 analysis, 1 of 32 HZ/su recipients (3.1%) and 16 of 477 placebo recipients (3.4%) with a confirmed HZ episode had complications other than PHN. Efficacy against HZ-related complications was 93.7% (95% confidence interval, 59.5–99.9%) in adults aged ≥50 years and 91.6% (43.3–99.8%) in adults ≥70 years. Five HZ-related hospitalizations, all in placebo recipients, and no HZ-related deaths were reported. ConclusionsHZ/su reduces the risk of HZ-associated complications in older adults (NCT01165177; NCT01165229).

Cost-effectiveness of the Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults

The live attenuated herpes zoster vaccine (ZVL) is recommended for immunocompetent adults 60 years or older, but the efficacy wanes with age and over time. A new adjuvanted herpes zoster subunit vaccine (HZ/su) has higher efficacy but might be more expensive. The choice of vaccines depends on their relative values. To assess the cost-effectiveness of HZ/su. Markov decision model with transition probabilities based on the US medical literature. Participants were immunocompetent adults 60 years or older. Data were derived from participant groups ranging in number from less than 100 to more than 30 000 depending on the variable assessed. The study dates were July 1 to 31, 2017. No vaccination, ZVL (single dose), and HZ/su (2-dose series) vaccine administered at different ages. Total costs and quality-adjusted life-years (QALYs) were estimated. Based on randomized clinical trial data, at a price of $280 per series ($140 per dose), HZ/su was more effective and less expensive than ZVL at all ages. The incremental cost-effectiveness ratios compared with no vaccination ranged from $20 038 to $30 084 per QALY, depending on vaccination age. The finding was insensitive to variations in most model inputs other than the vaccine price and certain combinations of low adherence rate with a second dose and low efficacy of a single dose of HZ/su. At the current ZVL price ($213 per dose), HZ/su had lower overall costs than ZVL up to a price of $350 per 2-dose series. In probabilistic sensitivity analysis, HZ/su had 73% probability of being cost-effective for 60-year-olds at $50 000 per QALY. Under conservative assumptions, at a price of $280 per series ($140 per dose), HZ/su would cost less than ZVL and has a high probability of offering good value.

Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study

BackgroundIn phase III trials, 2 doses of a herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) administered 2-months apart in older adults (≥50 and ≥70 years) demonstrated >90% efficacy in preventing HZ and had a clinically acceptable safety profile. Here we report immunogenicity, reactogenicity and safety following administration of 2 HZ/su doses at intervals longer than 2 months. MethodsIn this Phase III, open-label trial conducted in the US and Estonia, 354 adults ≥50 years were randomized 1:1:1 to receive 2 HZ/su doses 2, 6, or 12 months apart. gE-specific humoral immune responses were evaluated at pre-vaccination, 1 and 12 months post-dose 2. Co-primary objectives were to compare immune responses to HZ/su 1 month post-dose 2 when given 6-months or 12-months apart to those administered 2-months apart. For each participant, safety information was collected from dose 1 to 12 months post-dose 2. Results346 participants completed the study and 343 were included in the according-to-protocol cohort for immunogenicity. One month post-dose 2, vaccine response rates were 96.5% (97.5% confidence interval [CI]: 90.4; 99.2) and 94.5% (97.5% CI: 87.6; 98.3) for the 0, 6- and 0, 12-month schedules, respectively, both schedules meeting the pre-defined criterion. Non-inferiority of anti-gE geometric mean concentrations was demonstrated for HZ/su administered on 0, 6-month compared to a 0, 2-month schedule; however, HZ/su administered on a 0, 12-month schedule did not meet the non-inferiority criterion. Injection site pain was the most commonly reported solicited adverse event (AE). 26 participants each reported at least 1 serious AE; none were assessed as related to vaccination. ConclusionsImmune responses to HZ/su administered at 0, 6-month were non-inferior to those elicited by a 0, 2-month schedule. HZ/su exhibited a clinically acceptable safety profile for all dosing intervals.Clinical Trials Registration: Clinicaltrials.gov (NCT01751165).

Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults Previously Vaccinated with a Live-Attenuated Herpes Zoster Vaccine: A Phase III, Group-Matched, Clinical Trial

BackgroundHerpes zoster (HZ), caused by reactivation of varicella-zoster virus (VZV), typically manifests as a dermatomal rash and can lead to postherpetic neuralgia (PHN). HZ and PHN risk increase with age. Efficacy against HZ induced by a live-attenuated zoster vaccine (ZVL; Merck) declines following vaccination (21% in years 5–12 post-vaccination). To ensure protection, revaccination can be considered. Therefore, we assessed immunogenicity and safety of HZ/su, a non-live candidate vaccine containing VZV glycoprotein E (gE) subunit and AS01B adjuvant system (GSK), in adults previously vaccinated with ZVL ≥5 years before, (HZ-PreVac) compared with adults not vaccinated with ZVL (HZ-NonVac).MethodsIn this phase III, group-matched, open, multicenter study (NCT02581410), 2 parallel groups of adults ≥65 years of age (YOA) received 2 HZ/su doses 2 months apart. A co-primary objective was to compare humoral immune responses 1 month post-dose 2 (M3) in the 2 groups (non-inferiority criterion: upper limit [UL] of the 95% confidence interval [CI] for HZ-NonVac/HZ-PreVac adjusted anti-gE antibody geometric mean concentration [GMC] ratio <1.5). Humoral and cellular immune responses were evaluated at various time points. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days post each dose, respectively. Serious AEs (SAEs), HZ cases and potential immune-mediated diseases (pIMDs) will be recorded until study end. Here, we present data up to M3, as the study is still ongoing.Results430 participants were vaccinated. M3 humoral immune responses in HZ-PreVac were non-inferior to those in HZ-NonVac and the co-primary objective was met as the UL of the 95% CI of the adjusted GMC ratio was 1.17 (Table 1). In addition, there were no apparent differences in CD4[2+] T-cell frequencies between groups (Figure 1). No clinically meaningful differences between frequencies of solicited AEs, unsolicited AEs or SAEs in the 2 groups were observed (Table 2). No SAEs considered vaccine-related by investigators, no suspected HZ cases and no pIMDs were reported up to M3.ConclusionHZ/su vaccination in adults ≥65 YOA who previously received ZVL stimulates strong immune responses and does not raise safety concerns.FundingGlaxoSmithKline Biologicals SADisclosures K. Grupping, GSK group of companies: Employee, Salary; L. Campora, GSK group of companies: Employee, Salary; M. Douha, GSK group of companies: Employee, Salary; T. C. Heineman, GSK group of companies: Consultant and Shareholder, Consulting fee; N. P. Klein, GSK group of companies: Investigator, Grant recipient sanofi pasteur: Investigator, Grant recipient; Merck & Co: Investigator, Grant recipient; MedImmune: Investigator, Grant recipient; Protein Science: Investigator, Grant recipient; Pfizer: Investigator, Grant recipient; H. Lal, Pfizer: Employee and Shareholder, Salary and Stock as part of compensation; GSK group of companies: Employee at the time of study and Shareholder, Salary and Stock as part of compensation; J. Peterson, GSK group of companies: Investigator, Principal investigator fees; L. Oostvogels, GSK group of companies: Employee and Shareholder, Salary and Shares

Results of a Safety Pooled Analysis of an Adjuvanted Herpes Zoster Subunit Vaccine in More than 14,500 Participants Aged 50 Years or Older

BackgroundThe recombinant herpes zoster (HZ) subunit vaccine (HZ/su) has shown efficacy against HZ in adults ≥50 and ≥70 years of age (YOA), in two pivotal Phase III clinical trials (NCT01165177, NCT01165229). A pooled safety analysis of data from these two efficacy studies was performed, including a comparative analysis on HZ/su vs. placebo groups, to provide a comprehensive understanding of the HZ/su safety profile.MethodsTwo pivotal, randomized, placebo-controlled Phase III studies, assessed the efficacy, reactogenicity and safety of HZ/su, administered intramuscularly according to a 0, 2-month schedule. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each dose, respectively; serious AEs (SAEs) for 1 year after last dose; fatal and related SAEs and potential immune-mediated diseases (pIMDs) during the entire study period. Reactogenicity was assessed in a subset of participants; safety was assessed in all vaccinated participants.Results29,305 participants ≥50 YOA (HZ/su: 14,645; placebo: 14,660) were included in the pooled analysis. HZ/su was more reactogenic than placebo. Local reactions were mostly mild to moderate in intensity and transient (median duration = 3 days); the percentages of participants reporting SAEs, fatal SAEs and pIMDs were similar in both groups, at 30 days and 1 year after last dose (Figures 1 and 2). Percentages of fatal SAEs ranged between 4.3% (95% Confidence Interval [CI]: 4.0–4.7) and 4.6% (95% CI: 4.3–5.0) and pIMDs between 1.2% (95% CI: 1.1–1.4) and 1.4% (95% CI: 1.2–1.6), in HZ/su and placebo groups, respectively. In both groups, the most frequent causes of death were neoplasms, cardiac disorders, and respiratory tract infections and infestations, and most frequent pIMDs were polymyalgia rheumatica, rheumatoid arthritis and psoriasis.ConclusionNo safety concern was identified. Together with the high efficacy against HZ (97.2% [95% CI: 93.7–99.0],1 91.3% [95% CI: 86.8–94.5]2), the safety data supports a favorable benefit/risk profile of HZ/su in participants ≥50 YOA.FundingGlaxoSmithKline Biologicals SADisclosures M. López-Fauqued, GSK Biologicals’: Employee, Salary; L. Campora, GSK Biologicals’: Employee, Salary; F. Delannois, GSK Vaccines: Employee, Salary; M. El Idrissi, GSK Vaccines: Employee, Salary; E. Ledent, GSK Vaccines: Employee, Salary; J. Diez-Domingo, GSK Vaccines: Consultant and Investigator, Educational support and Research grant; J. McElhaney, GSK Vaccines: Scientific Advisor, Speaker honorarium; S. McNeil, GSK/Merck: Grant Investigator, Investigator and Scientific Advisor, Consulting fee, Grant recipient, Research grant, Research support and Speaker honorarium; F. De Looze, GSK Vaccines: Investigator and Research Contractor, Research support; F. Tavares Da Silva, GSK Vaccines: Employee, restricted shares and Salary

Clinical Usage of the Adjuvanted Herpes Zoster Subunit Vaccine (HZ/su): Revaccination of Recipients of Live Attenuated Zoster Vaccine and Coadministration With a Seasonal Influenza Vaccine.

Clinical Usage of the Adjuvanted Herpes Zoster Subunit Vaccine (HZ/su): Revaccination of Recipients of Live Attenuated Zoster Vaccine and Coadministration With a Seasonal Influenza Vaccine.

Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine

Protection against herpes zoster (HZ) induced by the live attenuated zoster vaccine Zostavax (ZVL) wanes within 3-7 years. Revaccination may renew protection. We assessed whether (re)vaccination with the adjuvanted HZ subunit vaccine candidate (HZ/su) induced comparable immune responses in previous ZVL recipients and ZVL-naive individuals (HZ-NonVac). In an open-label, multicenter study, adults ≥65 years of age, vaccinated with ZVL ≥5 years previously (HZ-PreVac), were matched to ZVL-naive adults (HZ-NonVac). Participants received 2 doses of HZ/su 2 months apart. The primary objective of noninferiority of the humoral immune response 1 month post-dose 2 was considered demonstrated if the upper limit of the 95% confidence interval (CI) of the adjusted anti-glycoprotein E geometric mean concentration (GMC) ratio of HZ-NonVac over HZ-PreVac was <1.5. HZ/su cellular immunogenicity, reactogenicity, and safety were also assessed. In 430 participants, humoral immune response to HZ/su was noninferior in HZ-PreVac compared with HZ-NonVac (adjusted GMC ratio, 1.04 [95% CI, .92-1.17]). Cellular immunogenicity, reactogenicity, and safety appeared to be comparable between groups. HZ/su was well-tolerated, with no safety concerns raised within 1 month post-dose 2. HZ/su induces a strong immune response irrespective of prior vaccination with ZVL, and may be an attractive option to revaccinate prior ZVL recipients. NCT02581410.

In adults ≥70 years of age, an adjuvanted herpes zoster subunit vaccine reduced herpes zoster at a mean 3.7 years.

Source Citation Cunningham AL, Lal H, Kovac M, et al; ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-32. 27626517

Su1831 Identifying “At Risk” Inflammatory Bowel Disease Patients Who May Be Targeted With a New Adjuvanted Herpes Zoster Subunit Vaccine

Su1831 Identifying “At Risk” Inflammatory Bowel Disease Patients Who May Be Targeted With a New Adjuvanted Herpes Zoster Subunit Vaccine

Commentary regarding: Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. H Lal, AL Cunningham, O Godeaux et al., N Engl J Med 372:2087-2096, 2015.

Commentary regarding: Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. H Lal, AL Cunningham, O Godeaux et al., N Engl J Med 372:2087-2096, 2015.

Persistence of the Immune Response to an Adjuvanted Herpes Zoster Subunit Vaccine in Healthy Older Adults: Modeling of Vaccine-Induced Immune Response, Data From a 6-Year Follow-Up Study

Persistence of the Immune Response to an Adjuvanted Herpes Zoster Subunit Vaccine in Healthy Older Adults: Modeling of Vaccine-Induced Immune Response, Data From a 6-Year Follow-Up Study