# GSK positive results from first-ever efficacy trial of Shingrix in China

- Link: https://www.directorstalkinterviews.com/gsk-positive-results-from-first-ever-efficacy-trial-of-shingrix-in-china/4121126148
- Published: 2023-08-23T07:41:19+01:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
LON/NYSE: GSK) has announced positive results from the first-ever efficacy trial
of _Shingrix_ (Recombinant Zoster Vaccine or RZV) in China. These results come from
the post-license phase IV trial (ZOSTER-076), which evaluated the efficacy and safety
of RZV in preventing shingles in adults aged 50 and over. The trial included almost
6,000 participants randomised 1:1 to the RZV or placebo group and followed in an
observer-blind design. No cases of shingles were reported among the participants
who received RZV, compared to 31 cases in the placebo arm.^(1)

·   No cases of shingles (herpes zoster) reported among the participants who received
_Shingrix_ (Recombinant Zoster Vaccine or RZV) in the randomised clinical trial^([
1])

·   The data come from the first efficacy trial of _Shingrix_ in China

·   The trial’s safety and efficacy data were consistent with GSK’s pivotal phase
III trials ZOE-50 and ZOE-70^(1)

The results are in line with findings from the pivotal phase III trials ZOE-50 and
ZOE-70 investigating the efficacy and safety of RZV, showing vaccine efficacy was
up to 97%^([2]) in adults aged 50 and over, over a follow-up period of approximately
four years.^(2)^(,)^([3]) The safety profile observed in this trial was consistent
with the established safety profile of the vaccine.^(1) The new data add to the 
growing body of evidence affirming the efficacy and safety profile of RZV in preventing
shingles in adults aged 50 and over.^(1)

Globally, the varicella zoster virus (VZV) is present in over 90% of adults.^([4])
^(,[5]) VZV remains dormant in the nervous system, waiting to reactivate as shingles
with advancing age.^(8)^(,)^(9) The population of people aged 65 and over in China
is rapidly increasing, with a predicted percentage increase from 6.8% in 2000 to
23.6% by 2050.^([6]) It is estimated that there are approximately 6 million cases
of shingles in China each year^(6), and this number is expected to increase in line
with local population ageing.

RZV was first licensed for use in China in 2019 for the prevention of herpes zoster
in adults aged 50 and over. This post-licence trial was undertaken to fulfil the
requirement of regulatory authorities to evaluate the vaccine efficacy and safety
of two doses of RZV for the prevention of shingles in China. The trial further demonstrates
RZV’s efficacy in preventing herpes zoster in adults aged 50 and over irrespective
of sex, geographic region and ancestry/ethnicity.

Results from this phase IV trial will be submitted for publication in a peer-reviewed
scientific journal later this year.

**About the ZOSTER-076 trial **

ZOSTER-076 was a phase IV, randomised, observer-blind, placebo-controlled, multi-
centre trial to assess the prophylactic efficacy against herpes zoster (HZ) and 
the immunogenicity and safety of RZV when administered intramuscularly on a 2-dose
schedule in adults aged 50 and over in China.^(1)

The trial was conducted between 2021 and 2023. It included almost 6,000 adults (
n=5,956). Vaccine efficacy was 100% (95% CI: 89.82%-100%). HZ incidence rate of 
0/1,000 person years in the RZV arm versus an incidence rate of 8.2/1,000 person
years in the placebo arm, p<0.0001.^(1) The safety profile observed in this trial
was consistent with the established safety profile of the vaccine.^(1)

**About shingles**

Shingles, also known as herpes zoster, is caused by a reactivation of the varicella-
zoster virus (VZV) – the same virus that causes chickenpox.^([7]) Globally, most
people aged 50 and over have the dormant VZV in their nervous system and are at 
risk of developing shingles.^(4,5) As people age, the strength of the immune system
wanes, leading to a decreased response to infection and thus increasing the risk
of developing shingles.^(4,5,7,[8],[9]) People with
a suppressed or compromised 
immune system are also at risk of shingles.^([10])

Shingles typically presents as a rash, with painful blisters across the chest, abdomen
or face.^(7) The pain is often described as aching, burning, stabbing or shock-like.
^(9) Following the rash, a person can also experience post-herpetic neuralgia (PHN),
a long-lasting nerve pain that can continue for weeks or months and in some cases
can persists for several years.^(9) PHN is the most common complication of shingles,
occurring in 5-30% of all shingles cases depending on the individual’s age.^([11])

**About **_**Shingrix**_

_Shingrix_ _(Recombinant Zoster Vaccine or RZV)_ is a non-live, recombinant subunit
vaccine indicated for the prevention of shingles in adults 50 and over. It combines
an antigen, glycoprotein E, with an adjuvant system, AS01_(B), and may help overcome
the natural age-related decline in responses to immunisation that contributes to
the challenge of protecting adults aged 50 and over from shingles.^([12])^(,[13])
RZV is not indicated to prevent primary varicella infection (chickenpox). In some
countries, RZV is also approved for adults aged 18 years or over who are at increased
risk for shingles.

**Please refer to the** **Product Information (PI)** **for important dosage, administration
and safety information in China available at this link:** https://portaldev2.igskapp.
com/media/916483/欣安立适说明书.pdf

^([1]) GSK data on file.

^([2]) Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older
Adults. N Engl J Med. 2015;372:2087-96.

^([3]) Cunningham AL, Lal H, Kovac M, et al. Efficacy of the Herpes Zoster Subunit
Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016;375(11):1019-1032.
doi:10.1056/NEJMoa1603800

^([4]) Bollaerts K et al. A systematic review of varicella seroprevalence in European
countries before universal childhood immunization: deriving incidence from seroprevalence
data. Epidemiol Infect 2017;145:2666-2677.

^([5]) Bricout H et al. Herpes zoster-associated mortality in Europe: a systematic
review. BMC Public Health 2015;15:466.

^([6]) Zhang Z et al. The incidence of herpes zoster in China: A meta-analysis and
evidence quality assessment. Hum Vaccin Immunother. 2023;19(2):2228169.

^([7]) Mueller, NH et al. Varicella Zoster Virus Infection: Clinical Features, Molecular
Pathogenesis of Disease and Latency. Neurologic Clinics, 2008; 26;675-697

^([8]) Johnson RW et al. Herpes zoster epidemiology, management, and disease and
economic burden in Europe: a multidisciplinary perspective. Therapeutic Advances
in Vaccines. 2015;3(4):109-120.

^([9]) Harpaz R et al. Advisory Committee on Immunization Practices (ACIP), Centers
for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations
of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(
RR-5):1-30.

^([10]) Huang C-T et al. Association Between Diabetes Mellitus and the Risk of Herpes
Zoster: A Systematic Review and Meta-analysis. J Clin Endocrinol Metab 2022;107:
586-597.

^([11]) Kawai K, Gebremeskel BG, Acosta CJSystematic review of incidence and complications
of herpes zoster: towards a global perspectiveBMJ Open 2014;4:e004833. doi: 10.1136/
bmjopen-2014-004833

^([12]) Cunningham et al. Vaccine profile of herpes zoster (HZ/su) subunit vaccine.
Expert Review of Vaccines. 2017;16:7;661-670.

^([13]) The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant
licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: 
AGEN), MPL and liposomes.

Share on: