[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the protective efficacy of attenuated live herpes zoster vaccine in people aged 40 years and above

主要目的：评价接种带状疱疹减毒活疫苗30天后预防带状疱疹的保护效力。次要目的：评价接种带状疱疹减毒活疫苗后预防带状疱疹的保护效力及30天后预防实验室诊断带状疱疹的保护效力和接种后的安全性、免疫原性和免疫持久性。探索性目的：探索接种带状疱疹减毒活疫苗30天后预防/减轻带状疱疹后遗神经痛（PHN）的保护效力。

[Translation]

Primary objective: To evaluate the protective efficacy of attenuated live zoster vaccine against herpes zoster 30 days after vaccination. Secondary objective: To evaluate the protective efficacy of attenuated live zoster vaccine against herpes zoster and the protective efficacy against laboratory-diagnosed herpes zoster 30 days after vaccination, as well as the safety, immunogenicity and immune persistence after vaccination. Exploratory objective: To explore the protective efficacy of attenuated live zoster vaccine against postherpetic neuralgia (PHN) 30 days after vaccination.

Start Date24 Apr 2020

Sponsor / Collaborator

Changchun BCHT Biotechnology Co.

CTR20160350

/ CompletedPhase 2

不同病毒含量带状疱疹减毒活疫苗在50岁及以上成人中的安全性研究

[Translation] Safety study of live attenuated herpes zoster vaccines with different virus contents in adults aged 50 years and above

评价不同病毒含量带状疱疹减毒活疫苗的免疫原性和安全性

[Translation]

Evaluation of immunogenicity and safety of live attenuated herpes zoster vaccines with different virus contents

Start Date30 May 2016

Sponsor / Collaborator

Changchun BCHT Biotechnology Co.

CTR20150830

/ CompletedPhase 1

不同病毒含量带状疱疹减毒活疫苗在50岁及以上成人中的安全性研究

[Translation] Safety study of live attenuated herpes zoster vaccines with different virus contents in adults aged 50 years and above

通过对50岁及以上成人接种试验疫苗，探索疫苗的安全性

[Translation]

Studying the safety of the vaccine by vaccinating adults aged 50 years and older

Start Date03 Dec 2015

Sponsor / Collaborator

Changchun BCHT Biotechnology Co.

100 Clinical Results associated with Zoster vaccine, Live(Changchun BCHT Biotechnology)

100 Translational Medicine associated with Zoster vaccine, Live(Changchun BCHT Biotechnology)

100 Patents (Medical) associated with Zoster vaccine, Live(Changchun BCHT Biotechnology)

Literatures (Medical) associated with Zoster vaccine, Live(Changchun BCHT Biotechnology)

01 Jan 2023·BMJ Open

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

Article

Author: Glover, Catherine ; Macartney, Kristine ; Hickie, Megan ; Hull, Brynley P ; Phillips, Anastasia ; Morgan, Adelaide ; Li-Kim-Moy, Jean ; Beard, Frank H ; Jayasinghe, Sanjay ; Dey, Aditi

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 settingZVL was funded in 2016 in Australia for people aged 70 years, with a catch-up programme for those 71–79 years. From 2016 to 2020, three deaths due to disseminated vaccine-strain VZV infection occurred following inadvertent ZVL administration in individuals with varying levels of immunocompromise. This descriptive study examined 4 years of national surveillance data reported to the Therapeutic Goods Administration’s Adverse Event Monitoring System (AEMS). Denominator data for rates were from doses recorded in the Australian Immunisation Register.ParticipantsIndividuals vaccinated between 1 November 2016 and 31 December 2020 who experienced adverse event(s) following immunisation (AEFI) after ZVL recorded in the AEMS.Primary and secondary outcome measuresRates and outcomes of confirmed (Oka strain positive) or probable disseminated VZV infection, and inadvertent administration of ZVL in immunocompromised individuals.Results854 AEFI were reported from 1 089 966 doses of ZVL administered (78.4 per 100 000 doses). Of those, 14 were classified as confirmed (n=6, 0.55 per 100 000) or probable (n=8) disseminated VZV infection. The confirmed cases were all hospitalised, and most (5/6) were immunocompromised; three cases died. Thirty-seven individuals were reported as vaccinated despite a contraindication due to immunocompromise (3.4 per 100 000), with 12/37 (32%) hospitalised.ConclusionsDisseminated VZV is potentially life-threatening and occurs mostly in those with severe immunocompromise. Inadvertent administration of ZVL to immunocompromised individuals has occurred despite initial provider guidance and education. Multiple additional strategies to assist providers to identify contraindications have been implemented to prevent adverse outcomes.

01 Mar 2021·VaccineQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: Lin, Jialing ; Bernardo, Carla ; Wood, James G ; Dobbins, Timothy ; Liu, Bette ; Stocks, Nigel P

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.

01 Dec 2020·The Journal of Heart and Lung TransplantationQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: Bos, Nicolaas A ; Verschuuren, Erik A M ; Raveling-Eelsing, Elisabeth ; Paap, Davy ; Rondaan, Christien ; Westra, Johanna ; Wang, Lei

BACKGROUNDHerpes 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.METHODSIn 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.RESULTSImmune 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.CONCLUSIONSZostavax 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.

100 Deals associated with Zoster vaccine, Live(Changchun BCHT Biotechnology)

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Indication	Country/Location	Organization	Date
Herpes Zoster	China	Changchun BCHT Biotechnology Co.	29 Jan 2023

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