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4.
Blood Adv ; 5(6): 1585-1593, 2021 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-33710336

RESUMO

Allogeneic hematopoietic cell transplantation (HCT) recipients are at increased risk for varicella zoster virus (VZV) reactivation and associated complications. A nonlive adjuvanted recombinant zoster vaccine (RZV) has been developed to prevent herpes zoster (HZ), but there are no recommendations for use in this population. In this single-center prospective observational cohort study, we assessed the safety and reactogenicity of RZV, as well as incidence of graft-versus-host disease (GVHD) and confirmed cases of HZ after vaccination. Between December of 2018 and June of 2020, patients aged ≥18 years received 2 doses of RZV between 9 and 24 months after HCT, with the doses separated by ≥8 weeks. One hundred and fifty-eight patients (mean age, 55 years; 42% women) received ≥1 dose (total vaccinated cohort), and 150 patients (95%) received 2 doses (modified total vaccinated cohort). Solicited reactions occurred in 92.1% of patients (grade 3, 32.5%), owing mostly to injection site pain, which occurred in 86% (grade 3, 16%). The cumulative incidence of GVHD in the peri-vaccination period was no different than in historical controls (adjusted incidence rate ratio, 1.05; 95% confidence interval, 0.8-1.38). There were 4 cases of HZ in the total vaccinated cohort (2.5%) and 3 cases in the modified total vaccinated cohort (28.3/1000 person-years). Among recipients of allogeneic HCT, RZV was safe, tolerable, and did not increase rates of GVHD. Future clinical trials are needed to determine the immunogenicity and efficacy of RZV in this population.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Vacina contra Herpes Zoster , Herpes Zoster , Adolescente , Adulto , Feminino , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Herpes Zoster/epidemiologia , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Vacinas Sintéticas
5.
BMJ Open ; 11(3): e043880, 2021 03 25.
Artigo em Inglês | MEDLINE | ID: mdl-33766842

RESUMO

OBJECTIVES: To 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 SETTING: ZVL was funded in Australia for adults aged 70 years from November 2016, with a time-limited catch up programme for those up to 79 years. This cohort study monitored safety in the first two programme years through active surveillance at 246 sentinel surveillance immunisation sites. PARTICIPANTS: Adults aged 70-79 years vaccinated with ZVL who responded to an opt-out survey sent via automated short message service (SMS) 3 days following vaccination (n=17 458) or contributed supplementary data through a separate, opt-in online survey at 16 and 24 days following vaccination (n=346). PRIMARY AND SECONDARY OUTCOME MEASURES: Rates of overall and prespecified adverse events following immunisation (AEFI) by sex, concomitant vaccination and underlying medical condition. Signal detection methods (fast initial response cumulative summation and Bayesian updating analyses) were applied to reports of medical attendance. RESULTS: The median age of participants was 72 years; 53% were female. The response rate following automated SMS was high (73% within 7 days of vaccination). Females were more likely than males to report any adverse event within 7 days of vaccination (RR 2.07, 95% CI 1.86 to 2.31); injection site reaction was the most commonly reported (2.3%, n=377). Concomitant vaccination was not associated with higher adverse event rates (RR 1.05, 95% CI 0.93 to 1.18). Rates of medical attendance were low (0.3%) with no safety signals identified. Supplementary opt-in survey data on later onset adverse events did not identify any difference in AEFI rates between those with and without underlying medical conditions. CONCLUSIONS: ZVL has a very good safety profile in the first week after vaccination in older adults. Active, participant-based surveillance in this primary care cohort is an effective method to monitor vaccine safety among older adults and will be used as a key component of COVID-19 vaccine safety surveillance in Australia.


Assuntos
Vacina contra Herpes Zoster/efeitos adversos , Herpes Zoster/prevenção & controle , Conduta Expectante , Idoso , Austrália/epidemiologia , Teorema de Bayes , Estudos de Coortes , Feminino , Herpes Zoster/epidemiologia , Vacina contra Herpes Zoster/administração & dosagem , Humanos , Masculino , Vacinação
6.
Am J Transplant ; 21(6): 2246-2253, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33565711

RESUMO

Lung transplant recipients are at high risk for herpes zoster and preventive measures are a significant unmet need. We investigated the safety and immunogenicity of two doses of a recombinant zoster vaccine (RZV) in lung transplant recipients (≥50 years). We enrolled 50 patients of which 49 received at least one vaccine dose. Anti-glycoprotein E (gE) antibody levels (n = 43) increased significantly compared to baseline (median optical density [OD] 1.96; interquartile range [IQR]: 1.17-2.89) after the first (median OD 3.41, IQR 2.54-3.81, p < .0001) and second vaccine dose (median OD 3.63, IQR 3.39-3.86, p < .0001). gE-specific polyfunctional CD4+ T cell frequencies (n = 38) also increased from baseline (median 85 per 106 CD4+ T cells; IQR: 46-180) to the first (median 128 per 106 CD4+ T cells; IQR: 82-353; p = .023) and after the second dose (median 361 per 106 CD4+ T cells; IQR: 146-848; p < .0001). Tenderness (83.0%; 95%CI: 69.2-92.4%) and redness (31.9%; 95%CI: 19.1-47.1%) at injection site were common. One rejection episode within 3 weeks of vaccination was observed. This is the first study demonstrating that RZV was safe and elicited significant humoral and cell-mediated immunity in lung transplant recipients. RZV is a new option for the prevention of shingles in this population.


Assuntos
Vacina contra Herpes Zoster , Herpes Zoster , Anticorpos Antivirais , Vacina contra Herpes Zoster/efeitos adversos , Humanos , Pulmão , Transplantados
7.
Hum Vaccin Immunother ; 17(7): 2050-2057, 2021 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-33606577

RESUMO

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.


Assuntos
Vacina contra Herpes Zoster , Herpes Zoster , Neuralgia Pós-Herpética , Adulto , Estudos de Coortes , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Herpesvirus Humano 3 , Humanos , Pessoa de Meia-Idade , Neuralgia Pós-Herpética/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
BMC Infect Dis ; 21(1): 117, 2021 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-33499826

RESUMO

BACKGROUND: Herpes zoster (HZ) infection of hematopoietic stem cell transplant (HSCT) patients is of clinical concern. Vaccination could help restore immunity to varicella zoster virus (VZV); however, temporal changes in immunogenicity and safety of live HZ vaccines after HSCT is still unclear. The aim of this study was to elucidate the temporal immunogenicity and safety of the HZ vaccine according to time since HSCT and to determine optimal timing of vaccination. METHODS: Live HZ vaccine was administered to patients 2-5 years or > 5 years post-HSCT. Control groups comprised patients with a hematologic malignancy who received cytotoxic chemotherapy and healthy volunteers. Humoral and cellular immunogenicity were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) and an interferon-γ (IFN-γ) enzyme-linked immunospot (ELISPOT) assay. Vaccine-related adverse events were also monitored. RESULTS: Fifty-six patients with hematologic malignancy (41 in the HSCT group and 15 in the chemotherapy group) along with 30 healthy volunteers were enrolled. The geometric mean fold rises (GMFRs) in humoral immune responses of the 2-5 year and > 5 year HSCT groups, and the healthy volunteer group, were comparable and significantly higher than that of the chemotherapy group (3.15, 95% CI [1.96-5.07] vs 5.05, 95% CI [2.50-10.20] vs 2.97, 95% CI [2.30-3.83] vs 1.42, 95% CI [1.08-1.86]). The GMFR of cellular immune responses was highest in the HSCT 2-5 year group and lowest in the chemotherapy group. No subject suffered clinically significant adverse events or reactivation of VZV within the follow-up period. CONCLUSION: Our findings demonstrate that a live HZ vaccine is immunogenic and safe when administered 2 years post-HSCT.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Vacina contra Herpes Zoster , Herpes Zoster/prevenção & controle , Herpesvirus Humano 3/imunologia , Transplantados , Vacinas Vivas não Atenuadas , Idoso , Anticorpos Antivirais/imunologia , Estudos de Casos e Controles , Feminino , Seguimentos , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/imunologia , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/estatística & dados numéricos , Vacina contra Herpes Zoster/efeitos adversos , Vacina contra Herpes Zoster/imunologia , Humanos , Imunogenicidade da Vacina/fisiologia , Masculino , Pessoa de Meia-Idade , Transplantados/estatística & dados numéricos , Resultado do Tratamento , Vacinação/efeitos adversos , Vacinação/métodos , Vacinação/estatística & dados numéricos , Vacinas Vivas não Atenuadas/efeitos adversos , Vacinas Vivas não Atenuadas/imunologia
10.
Vaccine ; 39(1): 6-10, 2021 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-33277059

RESUMO

BACKGROUND: Efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster (HZ) was demonstrated in pivotal trials ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). This study was designed to offer RZV to placebo recipients of these parent studies. METHODS: Vaccine safety and suspected HZ episode occurrence were assessed for 12 months following vaccination. RESULTS: Of the 14,550 eligible participants, 8687 received RZV and 97.8% completed the 2-dose schedule. During the 30-day post-vaccination period, 5175 (59.6%) participants experienced ≥ 1 unsolicited adverse event (AE), 4422 (50.9%) were vaccination-related. The most common AEs were injection-site reactions, pyrexia, and headache. During the study, 734 (8.4%) participants reported ≥ 1 serious AE (SAE) and 62 (0.7%) reported ≥ 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related. Suspected HZ episodes were reported by 30 participants (0.3%). CONCLUSIONS: Nature and incidence of AEs, SAEs, and pIMDs were as expected and in line with the parent studies.


Assuntos
Vacina contra Herpes Zoster , Herpes Zoster , Adjuvantes Imunológicos/efeitos adversos , Adulto , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Herpesvirus Humano 3 , Humanos , Pessoa de Meia-Idade , Vacinas Sintéticas/efeitos adversos
11.
Vaccine ; 38(47): 7455-7457, 2020 11 03.
Artigo em Inglês | MEDLINE | ID: mdl-33067034

RESUMO

Patients with inflammatory bowel disease, especially those on immunosuppressive therapy, are at higher risk of acquiring infectious diseases (Reich et al., 2016). For this reason, immunizations are routinely recommended in comprehensive inflammatory bowel disease care. SHINGRIX, a non-live recombinant herpes zoster vaccine, was approved by the Food and Drug Administration in 2017. Adults aged 50 and over are recommended to receive two doses of SHINGRIX. Unlike ZOSTAVAX® which is a live zoster vaccine that has been in use since 2006, SHINGRIX is safe for those on immunosuppression (Reich et al., 2016). The offside effects of SHINGRIX include injection-site erythema, tenderness, fatigue, and gastrointestinal upset. To our knowledge, blistering autoimmune skin disorders following SHINGRIX administration have not been reported. Here we discuss a case of a 74-year-old female patient with a history of ulcerative proctosigmoiditis on mesalamine who presented with a blistering skin disease after each SHINGRIX vaccination.


Assuntos
Colite Ulcerativa , Vacina contra Herpes Zoster , Herpes Zoster , Idoso , Feminino , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Humanos , Pessoa de Meia-Idade , Vacinação/efeitos adversos
12.
Vaccine ; 38(40): 6205-6214, 2020 09 11.
Artigo em Inglês | MEDLINE | ID: mdl-32788132

RESUMO

BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV) is indicated for prevention of herpes zoster (HZ) in adults aged ≥50 years. Questions regarding the use of RZV in immunocompromised patients < 50-year-old, who are at increased risk for HZ, were raised. OBJECTIVES: The objective of this systematic review was to consolidate existing evidences on safety, immunogenicity and efficacy of RZV in immunocompromised adults aged 18-49 years. METHODS: Four databases were searched. Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) guidelines were followed. Screening and classification of search items was performed using the web-based platform DistillerSR. RESULTS: The search identified 1389 potentially relevant records. Six studies fulfilled inclusion criteria. The proportion of patients aged 18-49 varied between 23 and 62%. Pain at injection site (98.6%) and fatigue (75.3%) were the most common adverse events. The proportion of patients reporting serious adverse events (SAEs) ranged between 8.1 and 30.8% in RZV and between 4.1 and 36.5% in placebo groups. SAEs deemed related to vaccination were reported in < 1% of patients in both RZV and placebo groups. The proportion of patients that experienced clinically significant underlying disease-related events ranged between 0.0 and 20.0% in RZV and 0.0 and 26.7% in placebo groups. The humoral and cell-mediated immune response rate ranged between 65.4 and 96.2% and 50.0-93.0%, respectively. Vaccine efficacy in hematopoietic stem cell transplant patients was 72% (95%CI, 39-88%) in 18-49-year-olds and 67% (95%CI, 53-78%) in ≥ 50-year-olds (median follow-up 21 months). Vaccine efficacy in ≥ 18-year-old patients with hematologic malignancies was estimated at 87.2% (95%CI, 44.3-98.6%) up to 13 months post-vaccination. CONCLUSIONS: Results suggest that RZV has an acceptable safety profile and induces immunity in an important proportion of ≥ 18-year-old immunocompromised patients. Longer follow-up studies are warranted to assess the duration of RZV induced immunity in immunocompromised patients.


Assuntos
Vacina contra Herpes Zoster , Herpes Zoster , Adolescente , Adulto , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Herpesvirus Humano 3 , Humanos , Hospedeiro Imunocomprometido , Pessoa de Meia-Idade , Vacinas Sintéticas/efeitos adversos , Adulto Jovem
13.
Vaccine ; 38(23): 3968-3979, 2020 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-32284271

RESUMO

BACKGROUND: Australia 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. METHODS: Individuals 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. RESULTS: A 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. CONCLUSION: No 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.


Assuntos
Vacina contra Herpes Zoster , Herpes Zoster , Idoso , Austrália/epidemiologia , Herpes Zoster/epidemiologia , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Humanos , Atenção Primária à Saúde , Vacinação , Vacinas Atenuadas
14.
Hum Vaccin Immunother ; 16(11): 2628-2633, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-32347767

RESUMO

In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age. Solicited adverse events (AEs) were collected for 7 days post-each dose in a study sub-cohort. The incidence of reported solicited AEs was higher for RZV compared to placebo recipients. Since reactogenicity may contribute to a person's willingness to be vaccinated, knowing about expected reactogenicity might help keep high compliance with the second dose. This post hoc analysis assessed the intensity of solicited AEs post-dose 2 reported to the same event's intensity post-dose 1. Intensity was graded from 0 to 3, grade 3 indicating the highest severity. Of the vaccinees who did not experience a specific AE post-dose 1, 72.6-91.7% did not experience the same event after dose 2. Although the frequency of grade 3 AEs post-dose 2 was the highest in participants reporting the same AEs at grade 3 post-dose 1, 65.8-89.3% of vaccinees with grade 3 specific AEs post-dose 1 reported the same AEs at lower intensity post-dose 2. These data can help inform health-care professionals about the frequency and intensity of AEs post-dose 2 with respect to post-dose 1.


Assuntos
Vacina contra Herpes Zoster , Herpes Zoster , Adulto , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Herpesvirus Humano 3 , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Vacinas Sintéticas/efeitos adversos
15.
Dig Dis Sci ; 65(10): 2986-2991, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-31897892

RESUMO

BACKGROUND: Patients with inflammatory bowel disease (IBD) are at increased risk of developing herpes zoster. In October 2017, the FDA approved a two-dose adjuvanted, recombinant herpes zoster vaccine (RZV). There is a theoretical concern that vaccine adjuvants may cause flares in patients with immune-mediated diseases. We aimed to assess the rates of IBD flare and adverse reactions after administration of RZV in a cohort of patients with IBD. METHODS: We conducted a prospective observational study of patients with IBD who received RZV between February 2018 and July 2019 at a tertiary IBD referral center. IBD activity scores were collected from patients during office visit or phone call after vaccination. The primary outcome was rate of IBD flare, defined as an increase in IBD activity, resulting in escalation of medical therapy, following vaccination. The secondary outcomes were rates of local and systemic adverse reactions after vaccination. RESULTS: We identified 67 patients (28 with ulcerative colitis and 39 with Crohn's disease) who received at least one dose of RZV. The two-dose vaccine series was completed by 55 patients (82%). Median duration of follow-up after vaccination was 207 days. One case of IBD flare was identified. No cases of herpes zoster were identified. Local and systemic adverse reactions were reported in 74.6% and 56.7% of patients, respectively. CONCLUSIONS: In this cohort of 67 patients, a low rate of IBD flare (1.5%) was observed after RZV administration. Rates of local and systemic adverse reactions were comparable to those seen in the RZV clinical trials.


Assuntos
Colite Ulcerativa/imunologia , Doença de Crohn/imunologia , Vacina contra Herpes Zoster/administração & dosagem , Herpes Zoster/prevenção & controle , Idoso , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/diagnóstico , Doença de Crohn/tratamento farmacológico , Progressão da Doença , Feminino , Herpes Zoster/diagnóstico , Herpes Zoster/imunologia , Vacina contra Herpes Zoster/efeitos adversos , Humanos , Esquemas de Imunização , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Vacinas Sintéticas/administração & dosagem
16.
Arthritis Care Res (Hoboken) ; 72(3): 353-359, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31207152

RESUMO

OBJECTIVE: To explore herpes zoster (HZ) rates and live zoster vaccine (LZV) safety in a subset of patients with rheumatoid arthritis who received LZV before tofacitinib ± methotrexate (MTX), or adalimumab (ADA) plus MTX in the ORAL Strategy. METHODS: ORAL Strategy was a 1-year, phase IIIb/IV, randomized, triple-dummy, active-comparator-controlled study. MTX-inadequate responder patients received tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID plus MTX, or ADA 40 mg every other week plus MTX (1:1:1 randomization). Eligible patients age ≥50 years could opt to receive LZV 28 days before initiating study treatment. HZ incidence rates (IRs; patients with events per 100 patient-years) were calculated. Opportunistic HZ infections (multidermatomal/disseminated), serious HZ events, and LZV-related adverse events were monitored. RESULTS: In ORAL Strategy, 216 of 1,146 patients (18.8%) received LZV. Overall, 18 patients (1.6%) developed HZ (vaccinated: n = 3; nonvaccinated: n = 15). HZ IRs were 1.1 (95% confidence interval [95% CI] 0.3-2.9), 2.3 (95% CI 1.0-4.6), and 1.7 (95% CI 0.6-3.7) for tofacitinib monotherapy, tofacitinib plus MTX, and ADA plus MTX, respectively, and were generally similar between vaccinated and nonvaccinated patients. Three multidermatomal, 1 disseminated, and 2 serious HZ events occurred. No vaccinated patients had zoster-like lesions within 42 days of vaccination; 1 patient had vaccination-site erythema. CONCLUSION: LZV was well tolerated, and HZ IRs were generally similar between treatment groups and vaccinated versus nonvaccinated patients. However, ORAL Strategy was not powered for comparisons between vaccinated and nonvaccinated patients because <20% of all patients were vaccinated. Furthermore, LZV has been shown to be effective only in ~50% of individuals.


Assuntos
Artrite Reumatoide/complicações , Vacina contra Herpes Zoster/efeitos adversos , Herpes Zoster/prevenção & controle , Inibidores de Janus Quinases/efeitos adversos , Piperidinas/efeitos adversos , Pirimidinas/efeitos adversos , Pirróis/efeitos adversos , Adalimumab/uso terapêutico , Adulto , Idoso , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Quimioterapia Combinada , Feminino , Herpes Zoster/induzido quimicamente , Herpes Zoster/epidemiologia , Humanos , Incidência , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade
17.
Vaccine ; 38(18): 3489-3500, 2020 04 16.
Artigo em Inglês | MEDLINE | ID: mdl-31818534

RESUMO

BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV) received its first marketing authorization in October 2017, for prevention of herpes zoster in individuals aged ≥50 years. METHODS: We summarized safety information, following RZV administration, received by GSK via spontaneous adverse event (AE) reports submitted by healthcare providers, vaccine recipients and other reporters. Observed-to-expected (O/E) analyses were performed for selected outcomes: reports of death, Guillain-Barré syndrome and Bell's palsy. Standard case definitions were used to assess individual case reports. Data mining, using proportional reporting ratio and time-to-onset signal detection methods, was employed to identify RZV-AE pairs with disproportionate reporting or unexpected time-to-onset distribution. RESULTS: Between October 13, 2017 and February 10, 2019, an estimated 9.3 million doses were distributed and GSK received 15,638 spontaneous AE reports involving RZV. Most reports were classified as non-serious (95.3%) and originated from the United States (81.7%), where the majority of doses were distributed. Among reports with age or sex reported, individuals were mainly 50-69-year-olds (62.1%) and female (66.7%). Of all reports, 3,579 (22.9%) described vaccination errors, of which 82.7% were without associated symptoms. Of all vaccination error reports, most described errors of vaccine preparation and reconstitution (29.7%), inappropriate schedule or incomplete course of administration (26.7%), incorrect route of administration (16.4%), and storage errors (12.9%). The most commonly reported symptoms were consistent with the known RZV reactogenicity profile observed in clinical trials, including injection site reactions, pyrexia, chills, fatigue, headache. O/E analyses for selected outcomes and data mining analyses for all reported AEs did not identify any unexpected patterns. CONCLUSIONS: Review of the initial data from the post-marketing safety surveillance showed that the safety profile of RZV is consistent with that previously observed in pre-licensure clinical trials. Other studies are ongoing and planned, to continue generating real-world safety data and further characterize RZV.


Assuntos
Vacina contra Herpes Zoster , Herpes Zoster , Idoso , Feminino , Herpes Zoster/prevenção & controle , Vacina contra Herpes Zoster/efeitos adversos , Herpesvirus Humano 3 , Humanos , Masculino , Marketing , Pessoa de Meia-Idade , Estados Unidos , Vacinas Sintéticas/efeitos adversos
18.
Expert Rev Pharmacoecon Outcomes Res ; 20(6): 613-621, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31721601

RESUMO

Objectives: Immunocompromised subjects are at increased risk for herpes zoster (HZ) and HZ-related complications, such as post-herpetic neuralgia (PHN). We describe health utilities, health care resource utilization (HCRU), productivity loss and health care costs in recipients of autologous hematopoietic stem-cell transplantation (Auto-HSCT) who developed confirmed HZ in the phase 3 clinical trial. Methods: HCRU, costs, and EQ-5D-3L utility were assessed for 155 confirmed HZ cases observed after receiving inactivated varicella-zoster virus (VZV) vaccine (ZVIN) or placebo. In a prospective, longitudinal 6-month follow up, costs and utilities were analyzed for two health states, HZ without PHN and HZ with PHN. Results: There was a clinically relevant difference in utility between HZ without PHN (mean 0.814) and HZ with PHN (0.729). The disutility for HZ without PHN was estimated to -0.117 and to -0.186 for HZ with PHN. Direct costs (2017 USD) associated with a HZ without PHN episode and HZ with PHN episode was estimated at $3,412 and $3,711, respectively, of which hospitalizations accounted for 90% of the costs. Expert opinion: Both HZ and PHN are associated with considerable disutility in recipients of Auto-HSCT. Costs were comparable to published estimates in other immunocompromised subjects. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT01229267).


Assuntos
Vacina contra Herpes Zoster/efeitos adversos , Herpes Zoster/economia , Hospedeiro Imunocomprometido , Neuralgia Pós-Herpética/economia , Adulto , Idoso , Método Duplo-Cego , Feminino , Seguimentos , Custos de Cuidados de Saúde/estatística & dados numéricos , Transplante de Células-Tronco Hematopoéticas/economia , Herpes Zoster/etiologia , Herpes Zoster/terapia , Vacina contra Herpes Zoster/administração & dosagem , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Neuralgia Pós-Herpética/etiologia , Neuralgia Pós-Herpética/terapia , Estudos Prospectivos , Adulto Jovem
20.
Pediatrics ; 144(3)2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31471448

RESUMO

CONTEXT: Live vaccines usually provide robust immunity but can transmit the vaccine virus. OBJECTIVE: To assess the characteristics of secondary transmission of the vaccine-strain varicella-zoster virus (Oka strain; vOka) on the basis of the published experience with use of live varicella and zoster vaccines. DATA SOURCES: Systematic review of Medline, Embase, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, and Scopus databases for articles published through 2018. STUDY SELECTION: Articles that reported original data on vOka transmission from persons who received vaccines containing the live attenuated varicella-zoster virus. DATA EXTRACTION: We abstracted data to describe vOka transmission by index patient's immune status, type (varicella or herpes zoster) and severity of illness, and whether transmission was laboratory confirmed. RESULTS: Twenty articles were included. We identified 13 patients with vOka varicella after transmission from 11 immunocompetent varicella vaccine recipients. In all instances, the vaccine recipient had a rash: 6 varicella-like and 5 herpes zoster. Transmission occurred mostly to household contacts. One additional case was not considered direct transmission from a vaccine recipient, but the mechanism was uncertain. Transmission from vaccinated immunocompromised children also occurred only if the vaccine recipient developed a rash postvaccination. Secondary cases of varicella caused by vOka were mild. LIMITATIONS: It is likely that other vOka transmission cases remain unpublished. CONCLUSIONS: Healthy, vaccinated persons have minimal risk for transmitting vOka to contacts and only if a rash is present. Our findings support the existing recommendations for routine varicella vaccination and the guidance that persons with vaccine-related rash avoid contact with susceptible persons at high risk for severe varicella complications.


Assuntos
Vacina contra Varicela/imunologia , Vacina contra Herpes Zoster/imunologia , Infecção pelo Vírus da Varicela-Zoster/transmissão , Vacina contra Varicela/efeitos adversos , Exantema/virologia , Vacina contra Herpes Zoster/efeitos adversos , Humanos , Imunocompetência , Hospedeiro Imunocomprometido , Fatores de Risco , Soroconversão , Índice de Gravidade de Doença , Vacinas Atenuadas
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