Recombinant herpes zoster epidemic Miao Xin Anlishi is able to provide protection for adults aged 50 years and older for at least 10 years

GlaxoSmithKline (GSK) today announced positive interim results from the ZOSTER-049 expansion study: initial vaccination against recombinant herpes zoster disease Miao Xin Anli provides at least 10 years of shingles protection ^[1]
.
The interim analysis will be presented
on October 22, 2022 at IDWeek in Washington, D.
C.

These results are from two phase III clinical trials ^[i]Zoster-006 (ZOE-50) and Zoster-022 (ZOE-70), an extension study ZOSTER-049 (ZOE-LTFU).

The results of these two previous phase III clinical trials showed that during the follow-up period of about 4 years after vaccination [ⁱ], the protective efficacy of Xin'an Lishi against herpes zoster in adults aged 50 years and older reached 97% [^2], and the protective efficacy of shingles in adults aged 70 years and older reached 91% ^[3].

The ZOE-LTFU study is designed to continue to
follow participants in the Zoster-006 and Zoster-022 clinical trials for six years.
Currently, ZOE-LTFU studies are still ongoing and will continue to evaluate the long-term efficacy, immunogenicity and safety
of the vaccine.

Dr.
Javier Díez-Domingo, principal investigator of the Foundation for the Promotion of Community Health and Biomedical Research (FISABIO) in Valencia, Spain, said: "Shingles is a distressing disease, with one in three people suffering from shingles in their lifetime ^[4].

Now, for the first time, we can confirm that vaccination against recombinant shingles provides an overall clinical benefit of at least 10 years, giving people and healthcare workers confidence
in the durability of vaccination against shingles.
"

Sabine Luik, Chief Medical Officer of GlaxoSmithKline and Senior Vice President, Global Healthcare Regulatory Affairs and Quality, said: "We are pleased to see that our shingles seedlings provide continued long-term protection
.
The results of the ZOE-LTFU study suggest that Shinanglix can provide protection for at least 10 years against pain, debilitation and potentially serious complications
in people 50 years of age and older caused by shingles.
These data complement the existing evidence and demonstrate the long-term benefits
of the disease.
We look forward to seeing more results
from this ongoing study.
" "

Shingles is caused by reactivation of the varicella-zoster virus (VZV)[2],[^4],[6].

As we age, the immune system loses the ability to generate a strong and effective immune response, which increases the risk of shingles [4],[^5],[6].

The condition causes unbearable pain, with some patients experiencing severe pain even after the rash has subsided, and this nerve pain, known as postherpetic neuralgia [PHN]), can last for months or even years ^[4].

Recombinant herpes zoster disease (RZV) is the first approved shingles vaccine that combines non-live antigens with GSK's patented adjuvant system to help overcome the decline in immune function that occurs with age and help protect older people from the disease [^7],[8].

About ZOSTER-049^[i].

ZOSTER-049 is an open-label, long-term follow-up (LTFU) study
based on two pivotal phase III clinical trials, Zoster-006 (ZOE-50) and Zoster-022 (ZOE-70).
The purpose of the study was to evaluate the protective efficacy, safety and immunogenicity
of the seedlings within 6 years following the Zoster-006 (ZOE-50) and Zoster-022 (ZOE-70) studies.
The results of the mid-term analysis at the fourth year showed that the protective efficacy of the seedlings was 81.
6%
between 5.
6 (±0.
3) and 9.
6 (±0.
3) after vaccination.
From 1 month to 10 years after the second dose (average 9.
6 (±0.
3) years after vaccination), the protective efficacy of the seedlings was 89.
0%.

Both extended and previous studies have confirmed good tolerability of the vaccines, and no new safety issues
have been identified.
The incidence of serious adverse events was positively correlated with the age of the study population, no deaths or other serious adverse events (SAEs) related to vaccination were reported, and a total of 5 cases of herpes zoster-related complications (3 postherpetic neuralgia and 2 disseminated shingles)
were reported.

A total of 7413 participants participated in the extended study
.
Participants were 60.
7% female and 39.
3% male
.
Participants were 76.
0% of white-Caucasian / European ancestry, 18.
7% Asian, and 5.
3% from other regions
.
The ZOSTER-049 study is being conducted in 18 countries, including Australia, Brazil, Canada, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, South Korea, Mexico, Spain, Sweden, Taiwan, the United Kingdom, and the United States
.

About shingles

Shingles typically presents as a rash with painful blisters on the chest, abdomen, or face ^[6].

Pain (associated with shingles) is often described as burning, tingling, or shock-like [^4].

Patients may be complicated by postherpetic neuralgia (PHN), which is pain
that persists for at least 3 months after the rash appears.
PHN is the most common complication of shingles, accounting for 5 to 25 percent of patients with shingles and is age-dependent ^[4].

About Shinan Lishi

Recombinant herpes zoster disease Miao Xin Anlishi is a non-live, recombinant sub-adjuvant disease that combines a recombinant antigen glycoprotein E and AS01B adjuvant system[^7],[8].

[i] Zoser-006 and Zoster-022 are two placebo-controlled studies in which the experimental group received two doses of recombinant herpes zoster virus (RZV)
according to a 0-2 immunization schedule.
The efficacy (VE) assessed by the investigator in the modified total vaccine vaccination cohort (mTVC) does not include adults
who have not received the second dose or who have been diagnosed with herpes zoster (HZ) within 1 month of receiving the second dose.
Data for ≥ 70-year-old subjects were derived from a pre-specified pooled analysis by Zoster-006/022, which provided reliable estimates of
VE.
HZ cases in RZV versus placebo: ≥ 50 years (Zoster-006; Median follow-up 3.
1 years): 6 vs.
210 vs.
7415; ≥ 70 years old (Zoster-006 and Zoster-022 pooled analysis; Median follow-up 4 years): 25 vs.
284 per 8346

       [1] Strezova A et al.
Long-term protection against herpes zoster (HZ) by the adjuvanted recombinant zoster vaccine (RZV): interim efficacy, immune and safety results at approximately 10 years after initial vaccination [abstract].
In: IDWeek 2022, 19-23 October 2022; Washington, DC, USA.

[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 et al.
Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older.
N Engl J Med.
2016; 375:1019-32.

[4] 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.

[5] Bricout H et al.
Herpes zoster-associated mortality in Europe: a systematic review.
BMC Public Health.
2015; 15:466.
Available at: https://doi.
org/10.
1186/s12889-015-1753-y Last accessed: October 2022.

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

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

       [8] 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.