Live Attenuated Herpes Zoster Research Articles

The effect of herpes zoster vaccination at different stages of the disease course of dementia: Two quasi-randomized studies.

The varicella zoster virus, a neurotropic herpesvirus, has been hypothesized to play a role in the pathophysiology of dementia, such as through neuroinflammatory processes or intracerebral vasculopathy. Using unique natural experiments, our group has previously found that live-attenuated herpes zoster (HZ) vaccination reduced the incidence of new diagnoses of dementia in both Wales and Australia. To inform further research and ultimately clinical care, it is crucial to understand at which stage of the disease course of dementia the HZ vaccine has its effect. Representing the two opposing ends of the dementia disease course as it can be ascertained from electronic health record data, the aims of this study were twofold: to determine the effect of HZ vaccination on i) new diagnoses of mild cognitive impairment (MCI) among individuals without any record of cognitive impairment, and ii) deaths due to dementia among individuals living with dementia. Our approach took advantage of the fact that at the time of the start date (September 1 2013) of the HZ vaccination program in Wales, individuals who had their eightieth birthday just after this date were eligible for HZ vaccination for one year whereas those who had their eightieth birthday just before were ineligible and remained ineligible for life. This eligibility rule created comparison groups just on either side of the September 2 1933 date-of-birth eligibility threshold who differed in their age by merely a week but had a large difference in their probability of receiving HZ vaccination. The key strength of our study is that these comparison groups should be similar in their health characteristics and behaviors except for a minute difference in age. We used regression discontinuity analysis to estimate the difference in our outcomes between individuals born just on either side of the date-of-birth eligibility threshold for HZ vaccination. Our dataset consisted of detailed country-wide electronic health record data from primary care in Wales, linked to hospital records and death certificates. We restricted our dataset to individuals born between September 1 1925 and September 1 1942. Among our study cohort of 282,557 without any record of cognitive impairment at baseline, HZ vaccination eligibility and receipt reduced the incidence of a new MCI diagnosis by 1.5 (95% CI: 0.5 - 2.9, p=0.006) and 3.1 (95% CI: 1.0 - 6.2, p=0.007) percentage points over nine years, respectively. Similarly, among our study cohort of 14,350 individuals who were living with dementia at baseline, being eligible for and receiving HZ vaccination reduced deaths due to dementia by 8.5 (95% CI: 0.6 - 18.5, p=0.036) and 29.5 (95% CI: 0.6 - 62.9, p=0.046) percentage points over nine years, respectively. Except for dementia, HZ vaccination did not have an effect on any of the ten most common causes of morbidity and mortality among adults aged 70 years and older in Wales in either of our two study cohorts. The protective effects of HZ vaccination for both MCI and deaths due to dementia were larger among women than men. Our findings suggest that the live-attenuated HZ vaccine has benefits for the dementia disease process at both ends of the disease course of dementia.

Herpes zoster vaccine and the risk of stroke: a population-based cohort study using linked data from the Clinical Practice Research Datalink

BackgroundStudies report herpes zoster associated with short-term stroke risk, but it is unclear whether herpes zoster vaccine reduces stroke risk.MethodsWe performed cohort studies using Clinical Practice Research Datalink Aurum linked...

Real-World Coverage With Influenza, Pneumococcal, and Herpes Zoster Vaccines Among Patients With Rheumatic Diseases in a Nationwide Healthcare Plan.

Vaccination against preventable infections is important for the management of rheumatic diseases (RDs). This study assessed the vaccination coverage and predictors among patients with RDs using real-world data from Israel. This retrospective cross-sectional study, based on a Maccabi Healthcare Services database, included adult patients diagnosed with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and systemic lupus erythematosus (SLE), as of April 30, 2019. Age-specific vaccination coverage for influenza (past year), pneumococcal (23-valent pneumococcal polysaccharide vaccine [PPSV23] and/or 13-valent pneumococcal conjugate vaccine [PCV13]), and live-attenuated herpes zoster (HZ) vaccines (past 5 years) was reported. Logistic regression was used to investigate predictors of vaccination. The study included 14,528 patients (RA: n = 6932; PsA: n = 4395; SLE: n = 1951; > 1 condition: n = 1250). Influenza vaccine coverage among patients with RA, PsA, and SLE was 45.1%, 36.2%, and 33.7%, respectively. For PPSV23, corresponding rates were 19.6%, 16.2%, and 12.6%, respectively. In the elderly population (≥ 65 years), 63.2% had influenza vaccine in the past year and 83.4% had a PPSV23 vaccine in the past 5 years or at age ≥ 65. For PCV13 and HZ, coverage in the overall study population was low at 4.8% and 3.6%, respectively. Central residence and treatment with corticosteroids and biologic or targeted synthetic disease-modifying antirheumatic drugs within the past 5 years were significant predictors of vaccination coverage across all vaccines (P < 0.05). Other predictors varied by vaccine, including female sex (influenza, PPSV23, PCV13), age (influenza, PPSV23), chronic comorbidities (influenza, PPSV23, PCV13), shorter disease duration (PCV13), and high socioeconomic status (PCV13, HZ). This study demonstrated suboptimal coverage of influenza, pneumococcal, and HZ vaccination in patients with RA, PsA, and SLE, in particular among younger adults in Israel.

Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia’s spontaneous vaccine pharmacovigilance system, 2016–2020

ObjectivesTo examine the reported incidence and features of disseminated varicella zoster virus (VZV) infection following live attenuated herpes zoster vaccine live (ZVL: Zostavax, Merck) in immunocompromised people in Australia.Design and...

Clinical effectiveness of live attenuated herpes zoster vaccine in kidney transplant recipients immunized prior to kidney transplantation: a retrospective single-center cohort study

Clinical effectiveness of live attenuated herpes zoster vaccine in kidney transplant recipients immunized prior to kidney transplantation: a retrospective single-center cohort study

Development of antibody-dependent cellular cytotoxicity in response to recombinant and live-attenuated herpes zoster vaccines

Zoster vaccines generate antibody responses against varicella-zoster virus (VZV). We compared antibody-dependent cell cytotoxicity (ADCC) elicited by zoster vaccine live (ZVL) and recombinant zoster vaccine (RZV). ADCC mediated by antibodies against VZV lysate (VZV-ADCC) and recombinant glycoprotein E (gE-ADCC) was measured using plasma from 20 RZV- and 20 ZVL-recipients, including half 50–60-years-old and half ≥70-years-old. Solid phase-bound anti-VZV antibodies stimulated TNFα in NK cells as measured by flow cytometry or ELISA. VZV-ADCC pre- and post-immunization was higher in younger vaccinees. ZVL did not appreciably increase VZV-ADCC, whereas RZV increased VZV-ADCC in older vaccinees. ELISA-measured gE-ADCC was similar across groups pre-immunization; significantly increased after ZVL; and RZV and was higher in younger RZV than ZVL recipients. IgG3 antibodies increased after RZV and ZVL, with greater anti-gE than anti-VZV responses. Moreover, gE-ADCC strongly correlated with anti-gE antibody avidity, but there were no appreciable correlations between VZV-ADCC and avidity. NK cells stimulated by anti-gE antibodies showed increased IFNγ and CD107a expression, which was not observed with anti-VZV antibodies. In conclusion, anti-gE antibodies generated more robust ADCC than anti-VZV antibodies. RZV induced higher ADCC antibodies than ZVL depending on the antigen and age of vaccinees. Older adults had lower ADCC antibodies before and after vaccination than younger adults.

General practitioner knowledge gaps regarding live attenuated zoster vaccination of immunocompromised individuals: An ongoing concern?

Live attenuated herpes zoster vaccine (Zostavax [CSL/Merck]) was included on the Australian National Immunisation Program from 1 November 2016 for adults aged 70 years, with a catch-up program for adults aged 71-79 years. The aim of this study was to assess the knowledge of Australian general practitioners (GPs) regarding Zostavax. A national cross-sectional online survey was distributed to GPs by Healthed, a private health education provider. Of 605 GPs, 502 responded to the survey (response rate 83%). Eighty-nine per cent were aware that Zostavax is funded and recommended for adults aged 70-79 years. Approximately 10% incorrectly responded that immunocompromise is not a contraindication to Zostavax, and 8% were unsure. For five clinical scenarios assessing knowledge of Zostavax contraindications, theproportion of correct responses ranged 25-82%. While most GPs surveyed had good knowledge, notable gaps were identified. Further efforts are needed to promote awareness of recommendations, particularly for immunocompromised individuals. The availability of Shingrix, a non-live recombinant subunit zoster vaccine, in the private market provides an alternative, especially for immuncompromised patients.

Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance

ObjectivesTo assess the safety of live attenuated herpes zoster vaccine live (ZVL) through cumulative analysis of near real-time, participant-based active surveillance from Australia’s AusVaxSafety system.Design and settingZVL was funded in...

Ageing of Immune System and Response to a Live-Attenuated Herpes Zoster Vaccine in Lung Transplant Candidates.

The mean age of lung transplant recipients has significantly increased in recent decades. Elderly recipients have a higher risk of developing herpes zoster (HZ), and they have in general a worse response to vaccination than younger persons do. We investigated the relationship between the humoral and cellular immune response to a live-attenuated HZ vaccine (Zostavax®, Merck Sharp and Dohme) and the frequencies of T and B cell subsets, especially aged cell subsets (CD28−T cells and age associated B cells, ABCs). In total, 37 patients awaiting lung transplantation received one dose of Zostavax®, and peripheral blood was collected before and within 6 months after vaccination. We observed a robust immune response after vaccination. The frequencies of CD28−T cells before vaccination had no impact on the subsequent immune response to HZ vaccination. However, a higher frequency of ABCs before vaccination correlated with a lower immune response especially regarding the cellular immune response. Cytomegalovirus seropositivity was associated with increased frequencies of CD28−T cells but not with frequencies of ABCs in the patients. In conclusion, increased levels of ABCs might disturb the cellular immune response to HZ vaccination, which could lower the efficacy of such vaccination in elderly transplant recipients.

Effectiveness of the live-attenuated herpes zoster vaccine 2 years after its introduction in Australia

BackgroundThe Australian National Herpes Zoster Immunisation Program commenced in November 2016 for people aged 70–79 years old in Australia but vaccine effectiveness (VE) in this setting has not previously been assessed. MethodsWe extracted records from two cohorts of patients aged 70–79 years in 2017 and 2018 respectively who were regular attenders in a nationwide general practice dataset, MedicineInsight. Cox proportional hazards models were used to estimate VE. Models were adjusted for potential confounders including age, sex, and other covariates. Analyses were also stratified by sex, presence of comorbid conditions and number of general practitioner (GP) visits in the previous year. ResultsThe 2017 cohort included 40,275 regular attenders and the 2018 cohort 41,735. Both cohorts had a mean age of 73.9 years and 52% were women. In 2017, among vaccinated people, over 9,688 person-years of follow-up, 35 cases of zoster were diagnosed giving an incidence of 3.6 per 1000 person-years compared to 8.7 per 1000 person-years (264 cases/30,317 person-years) among unvaccinated people. For 2018, among vaccinated people there were 66 incident zoster cases over 16,716 person-years giving an incidence of 3.9 per 1000 person-years compared to 6.3 per 1000 person-years (156 cases/24,782 person-years) among the unvaccinated. Overall, in the first year of the program, when the average time since vaccination was about 8 months, VE was 63.5% (95% CI: 47.5, 74.6) but this fell to 48.2% (95% CI: 30.0, 61.7) in the second year when the average time since vaccination was about 18 months. We found no difference in VE across age, sex, presence of comorbid conditions, and prior GP visit frequency (P-interaction > 0.05). ConclusionsVE was consistent with that estimated in other countries and international settings. However, our findings suggest waning effectiveness after the first year of the program. Further program evaluation is necessary.

Prophylactic vaccination with a live-attenuated herpes zoster vaccine in lung transplant candidates

Herpes zoster (HZ) is caused by the reactivation of varicella-zoster virus (VZV). Patients with lung transplants are at high risk for HZ owing to their immunocompromised status and the need for lifelong immunosuppression. In this study, patients on the waiting list for lung transplantation were vaccinated by a live-attenuated HZ vaccine (Zostavax, Merck Sharp & Dohme), and the safety and immunogenicity of this vaccine were studied. In total, 105 patients with end-stage pulmonary disease (ESPD) were enrolled (68 participants received 1 dose of Zostavax and 37 participants were enrolled as unvaccinated controls). Among them, 43 patients underwent lung transplantation and were followed up for further analysis. VZV immunoglobulin G antibody titers and VZV-specific cell-mediated immunity (CMI) on multiple time points before and after vaccination and before and after transplantation were measured. Immune response to Zostavax was higher in younger patients, highest within 3 months after vaccination, and not influenced by gender or type of ESPD. Age, cytomegalovirus serostatus, and immunity to VZV at baseline impacted the subsequent immune response to the vaccine. Short-term immunosuppressant treatment had strong effects on VZV CMI levels, which returned to a high level at 6 months after transplantation in vaccinated patients. Zostavax did not impact infection or rejection rate after transplantation. Zostavax was safe and induced a robust humoral and cellular response for patients awaiting lung transplantation regardless of the type of ESPD. Patients younger than the recommended vaccination age of over 50 years showed a strong response and could also benefit from pre-transplant immunization.

Safety of live attenuated herpes zoster vaccine in adults 70–79 years: A self-controlled case series analysis using primary care data from Australia’s MedicineInsight program

BackgroundAustralia introduced a funded shingles vaccination program for older adults in November 2016, administered predominantly in primary care clinics. MedicineInsight, a nationally representative primary care database, was used to investigate the risk of pre-specified outcomes following live attenuated herpes zoster vaccine (ZVL) in Australia. MethodsIndividuals aged 70–79 years who received ZVL between 1 November 2016 and 31 July 2018 were identified from MedicineInsight. The self-controlled case series (SCCS) method was used to estimate the seasonally-adjusted relative incidence (RI) of seven pre-specified outcome events (injection site reaction (ISR) [positive control], burn [negative control], myocardial infarction (MI), stroke, rash, rash with an antiviral prescription, and clinical attendance) during a plausible post-vaccination at-risk window compared with times distant from vaccination. Sensitivity analyses examined the effect of common concomitant vaccinations and restriction to first outcome events. ResultsA total of 332,988 vaccination encounters among 150,054 individuals were identified during the study period; over 2 million clinical attendances were observed. There was an increased RI of ISR in the seven days following ZVL (RI = 77.4, 95% CI 48.1–124.6); the RI of clinical attendance (RI = 0.94, 95% CI 0.94–0.95) and stroke (RI = 0.58, 95% CI 0.44–0.78) were lower in the 42 days following administration of ZVL compared to control periods. There was no evidence of a change in the RI of MI (RI = 0.74, 95% CI 0.41–1.33), rash (RI = 0.97, 95% CI 0.88–1.08), or rash with antiviral prescription (RI = 0.83, 95% CI 0.62–1.10) in the 42 days following ZVL compared to control periods. ConclusionNo new safety concerns were identified for ZVL in this study based on a novel, Australian primary care data source. An expected increased risk of ISR was identified; findings in relation to cardiovascular disease were reassuring but require confirmation using additional data, including hospital records.

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

BackgroundEfficacy 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.MethodsAdults 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.ResultsThrough 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.ConclusionsRZV 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 RegistrationNCT02581410.

Impact of a Publicly Funded Herpes Zoster Immunization Program on the Burden of Disease in Ontario, Canada: A Population-based Study.

BackgroundIn September 2009, a live attenuated herpes zoster vaccine (ZVL) became available in Canada. Beginning in September 2016, ZVL was made available to all Ontario residents aged 65–70 through a publicly funded immunization program. We assessed the impact of ZVL availability and its subsequent public funding on herpes zoster burden in this population.MethodsA population-based study of Ontario residents aged 65–70 between January 2005 and September 2018. We used interventional autoregressive integrated moving average models to examine the impact of ZVL market availability and the publicly funded ZVL program on monthly incidence rate of medically attended herpes zoster, defined as an outpatient visit for herpes zoster with a prescription for a herpes zoster antiviral dispensed ≤5 days before or after the visit, or a herpes zoster–related emergency department (ED) visit or hospitalization. In secondary analyses, we examined impacts on any herpes zoster–related ED visits and hospitalizations.ResultsWe found no association between ZVL market availability and monthly incidence of herpes zoster (P = .32) or monthly rates of ED visits and hospitalizations (P = .88). Conversely, the introduction of publicly funded ZVL reduced the monthly rate of medically attended herpes zoster by 19.1% (from 4.8 to 3.8 per 10 000 population; P < .01) and herpes zoster–related ED visits and hospitalizations by 38.2% (from 1.7 to 1.0 per 10 000 population; P < .05).ConclusionsThe introduction of a publicly funded immunization program for herpes zoster was associated with reduced disease burden and related acute healthcare service use.

Safety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial

ObjectivesTo study the safety and immunogenicity of a live-attenuated herpes zoster (HZ) vaccine in patients with systemic lupus erythematosus (SLE).MethodsAdult SLE patients having a SLEDAI <6 and stable immunosuppressive treatment...

Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax® in healthy adults aged 50 years and older

A multi-centre, randomised, double-blinded, active-controlled, parallel-group clinical trial was carried out to assess the immunogenicity and safety of NBP608—a newly developed live-attenuated zoster vaccine in Korea—relative to Zostavax® in healthy adults aged 50 years or older. Immune responses to the vaccine were evaluated by glycoprotein enzyme-linked immunosorbent assay (gpELISA) and enzyme-linked immunosorbent spot (ELISPOT) assays using the interferon (IFN)-γ and interleukin (IL)-2 FluoroSpot kit 6 weeks after vaccination. Safety was monitored for 26 weeks based on subjects’ diaries, spontaneous reports from subjects, and history taking by the investigators. A total of 845 subjects participated in the screening, and 823 received the vaccination (413 in the NBP608 group and 411 in the comparator group). The gpELISA-determined geometric mean fold rise from baseline to post NBP608 vaccination was 2.75 [95% confidence interval, CI (2.57, 2.94)]. The gpELISA-determined adjusted geometric mean titers (GMTs) of NBP608 and the comparator were 1346.37 [95% CI (1273.99, 1422.87)] and 1674.94 [95% CI (1585.35, 1769.58)], respectively. The adjusted GMT ratio of NBP608 to the comparator was 0.80 [95% CI (0.75, 0.87)]. There was no statistically significant difference between two groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post vaccination (P = 0.7232, 0.3844). The incidence of adverse events (AEs) within 6 weeks post vaccination was 49.82% overall (410/823, 941 cases), 50.73% (209/412, 474 cases) in the NBP608 group, and 48.91% (201/411, 467 cases) in the comparator group. The difference in AE rate between the two groups was not statistically significant (P = 0.6010). Most AEs were mild, with a rate of 83.12% in the NBP608 group and 75.37% in the comparator group. Thus, NBP608 is non-inferior to Zostavax® in terms of inducing the immune response and can be safely administered to adults aged 50 years or older.ClinicalTrials.gov Identifier: NCT03120364.

Using the Self-Controlled Tree-Temporal Scan Statistic to Assess the Safety of Live Attenuated Herpes Zoster Vaccine.

The self-controlled tree-temporal scan statistic allows detection of potential vaccine- or drug-associated adverse events without prespecifying the specific events or postexposure risk intervals of concern. It thus opens a promising new avenue for safety studies. The method has been successfully used to evaluate the safety of 2 vaccines for adolescents and young adults, but its suitability to study vaccines for older adults had not been established. The present study applied the method to assess the safety of live attenuated herpes zoster vaccination during 2011-2017 in US adults aged ≥60 years, using claims data from Truven Health MarketScan Research Databases. Counts of International Classification of Diseases diagnosis codes recorded in emergency department or hospital settings were scanned for any statistically unusual clustering within a hierarchical tree structure of diagnoses and within 42 days after vaccination. Among 1.24 million vaccinations, 4 clusters were found: cellulitis on days 1-3, nonspecific erythematous condition on days 2-4, "other complications . . ." on days 1-3, and nonspecific allergy on days 1-6. These results are consistent with local injection-site reactions and other known, generally mild, vaccine-associated adverse events and a favorable safety profile. This method might be useful for assessing the safety of other vaccines for older adults.

Exam 3: Efficacy of Live Attenuated Herpes Zoster Vaccine in Patients With Inflammatory Bowel Diseases

Exam 3: Efficacy of Live Attenuated Herpes Zoster Vaccine in Patients With Inflammatory Bowel Diseases

1956. Persistence of Immune Response and Safety of an Adjuvanted Recombinant Zoster Vaccine in Older Adults Previously Vaccinated with a Live-Attenuated Herpes Zoster Vaccine: End-of-Study Results of 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 result in complications, such as postherpetic neuralgia. HZ risk increases with age due to age-related decline of immunity. At time of study start, Zoster Vaccine Live (ZVL), containing live-attenuated VZV was recommended for vaccination in adults ≥60 years of age. Efficacy of ZVL declines with time since vaccination and increasing age. We evaluated immunogenicity and safety of Adjuvanted Recombinant Zoster Vaccine (RZV) containing truncated form of VZV glycoprotein E (gE) in adults vaccinated with ZVL ≥5 years before (HZ-PreVac) and ZVL-naïve adults (HZ-NonVac). In October 2017, the Advisory Committee on Immunization Practices recommended revaccination of ZVL recipients with RZV, based on available data, including 1 month (M) post-dose 2 results of this study (M3). Here we present immunogenicity and safety results up to 12 months post-dose 2 (M14).MethodsIn this phase III, multi-center study (NCT02581410), open-label, 2 parallel groups of group-matched adults ≥65 years of age, HZ-PreVac and HZ-NonVac, received 2 RZV doses 2 months apart. Humoral and cellular immune responses were evaluated at various time points up to M14. 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) were recorded throughout the study.Results215 participants were vaccinated in each group. No apparent differences, in pre-vaccination and persistence values of the anti-gE antibody GMCs (Figure 1) and CD4[2+] T-cell frequencies (Figure 2) were observed between HZ-PreVac and HZ-NonVac, up to M14. No clinically relevant differences in frequencies of solicited AEs, unsolicited AEs or SAEs between the two groups were observed. Six pIMDs (two in HZ-PreVac group and four in HZ-NonVac group), were reported up to M14 (Table 1). ConclusionIn both groups, RZV-induced humoral and cellular immune responses persisted above baseline up to M14 at similar levels, irrespective of previous ZVL administration. Safety profile was similar regardless of previous ZVL vaccination. Funding: GlaxoSmithKline Biologicals SA.Disclosures T. Mrkvan, GSK: Employee and Shareholder, Salary and shares and share options. L. Campora, GSK: Employee and Shareholder, Salary. G. Catteau, GSK: Board Member, Salary. M. Douha, GSK: Employee, Salary. K. Grupping, GSK: Employee, Salary. C. Herve, GSK: Employee, Salary. G. Kalema, GSK: Consultant, Consulting fee. T. Heineman, GSK: Consultant, Employee and Shareholder, Consulting fee and Salary. N. P. Klein, GSK: Investigator, Research support. sanofi pasteur: Investigator, Research support. Merck: Investigator, Research support. Pfizer: Investigator, Research support. Protein Science: Investigator, Research support. MedImmune: Investigator, Research support. Dynavax: Investigator, Research support. H. Lal, GSK: Shareholder, Salary. Pfizer: Shareholder, Salary. L. Oostvogels, GSK: Employee, Salary and stock and stock options. A. Schuind, GSK: Employee and Shareholder, Salary.

Efficacy of Live Attenuated Herpes Zoster Vaccine in Patients With Inflammatory Bowel Diseases

The risk of herpes zoster virus infection is increased among patients with inflammatory bowel diseases (IBD). The herpes zoster vaccine (HZV) is therefore recommended for these patients, but little is known about its effectiveness, resulting in low use. We conducted a retrospective cohort study using data from the national veterans Affairs Healthcare System (VAHS) from January 1, 2000 through June 30, 2016. We collected data from 39,983 veterans with IBD who had not received the HZV by an age of 60 years. The follow-up period started at age 60 or the date of first IBD medication prescription (whichever was later) and ended with the earliest diagnosis of herpes zoster infection, the end of the study period, or date of death. We identified veterans who received the HZV during the follow-up period and compared the incidence of herpes zoster between vaccinated vs unvaccinated patients. We performed multivariable Cox regression with time-dependent analysis to determine the risk of herpes zoster associated with vaccination status in the entire cohort and stratified by IBD medication. We identified 7170 patients who received the HZV during the follow-up period (17.9% of total cohort; 96.6% male and 94.2% Caucasian). The crude incidence rate of herpes zoster infection during the follow-up period for unvaccinated patients was 6.97/1000 person-years and for vaccinated patients was 4.09/1000 person-years. Vaccination was associated with significantly lower risk of herpes zoster infection, compared to lack of vaccination (adjusted hazard ratio, 0.54; 95% CI, 0.44 - 0.68). Vaccination was associated with a significantly reduced risk of herpes zoster infection among veterans with IBD. This vaccine is therefore effective in patients with IBD, but underused.