LONDON, Sept. 14, 2016 /PRNewswire/ -- GSK (LSE/NYSE:
GSK) today announced the publication of detailed results from a
randomised phase III study (ZOE-70) of its investigational shingles
vaccine, Shingrix™, showing 90% efficacy in adults aged 70 years
and older that is maintained for at least four years1.
The results were published in the New England Journal of Medicine
(NEJM).
The study, from which headline results were reported in
October 2015, showed that the
two-dose candidate shingles vaccine had 90% efficacy (95%
confidence interval: 84-94%) compared to placebo in people over 70
years old. Vaccine efficacy was maintained across the various age
groups included in the study, ranging between 90% in people aged
70-79 years (95% confidence interval: 83-94%) and 89% in those aged
80 years and above1 (95% confidence interval:
74-96%)1.
The high efficacy is in line with the results of the ZOE-50
trial, a study in people over 50 years old which was presented and
published last year showing a 97% efficacy (95% confidence
interval: 93-99%)2. A pooled analysis of data from both
trials showed the vaccine demonstrated 91% efficacy against
shingles (95% confidence interval: 86-95%) in adults aged 70 years
and older compared to placebo1. This efficacy was
maintained with an 88% reduction in the risk of shingles (95%
confidence interval: 73-95%) in the fourth year after
vaccination.
The risk of serious adverse events, potential immune-mediated
diseases or deaths observed in ZOE-70 was similar in people
receiving Shingrix and placebo. The most commonly reported local
adverse reaction was pain at the injection site and the most
frequently reported systemic adverse reaction was fatigue. The
majority of injection site and systemic reactions occurred within
seven days of vaccination, with most lasting 1-3 days, and
generally were mild-to-moderate in intensity1.
In addition, a pooled analysis of data from the ZOE-70 and
ZOE-50 trials showed that the candidate vaccine effectively reduced
the risk of subsequent chronic neuropathic pain, also known as
postherpetic neuralgia (PHN)1 which is the most common,
and often severe, complication of shingles3,4. The
candidate vaccine was shown to be 89% (95% confidence interval:
68-97%) efficacious in preventing PHN in people aged 70 years and
older and 91% efficacious (95% confidence interval: 75-98%) in
people aged 50 years and over1.
Dr Emmanuel Hanon, Senior Vice
President, Vaccines Research and Development, GSK, said: "This
is the first time that such high efficacy has been demonstrated in
a vaccine candidate for older people and it is remarkable, as we
know that these people frequently have an age-related weakening of
their immune system. If approved, this candidate vaccine could be
an important tool for the prevention of shingles and the pain
associated with it, which would significantly impact the health and
quality of life of so many people."
Anthony Cunningham, Executive
Director of the Westmead Institute for Medical Research in
Australia and Principal
Investigator of the ZOE-70 study said: "These data show
that this investigational vaccine
maintains high efficacy against herpes zoster in people
over 70 and 80 years of age, the age groups who are most
affected by the disease. Importantly, it also prevents a
common and feared complication of herpes zoster, prolonged pain, or
post herpetic neuralgia in these groups."
Based on these and the previously reported ZOE-50
data2, GSK expects to start submitting regulatory
applications for the candidate vaccine for the prevention of
shingles in people 50 years and above later this year.
About Shingrix
Shingrix is a non-live, adjuvanted,
subunit (HZ/su) candidate vaccine to help prevent herpes
zoster and its complications. The candidate vaccine combines
glycoprotein E, a protein found on the varicella zoster virus (VZV)
that causes shingles, with an adjuvant system, AS01B,
which is intended to enhance the immunological response to the
antigen5.
Additional trials to evaluate the ability of Shingrix to help
prevent shingles are ongoing in healthy people aged 50 and older
and in adults with compromised immune systems. These studies will
provide additional information with respect to the efficacy and
safety profile of the candidate vaccine as well as its
ability to stimulate immune responses in other populations and in
specific circumstances.
Notes to editors
The name Shingrix is not yet approved
for use by regulatory authorities in most countries, including the
US Food and Drug Administration (FDA).
About the ZOE-70 trial
The ZOE-70 (ZOster Efficacy in
adults aged 70 years and over) (NCT01165229) study is a randomised,
observer-blind, placebo-controlled (saline solution) multicentre,
multinational (North America,
Europe, Latin America, Asia-Pacific) phase III trial involving more
than 14,800 adults aged 70 years and older. Two doses were given
intramuscularly two months apart. The study, which started in
August 2010 in parallel with the
ZOE-50 trial, includes subjects in the age ranges 70-79 and ≥80
years. The primary objective of ZOE-70 is overall vaccine efficacy
against shingles in people 70 years and over, compared to placebo.
The co-primary objectives of the pooled analysis over both studies
are the assessment of overall vaccine efficacy in reducing the risk
of developing shingles and PHN in people aged 70 years and over,
using pooled data from both ZOE-70 and ZOE-50 studies.
About the ZOE-50 trial
The ZOE-50 (ZOster Efficacy in
adults aged 50 years and over) (NCT01165177) study is a randomised,
observer-blind, placebo-controlled (saline solution) multicentre,
multinational (North America,
Europe, Latin America, Asia-Pacific) phase III trial involving 16,160
adults aged 50 years and older. The study started in August 2010. Two doses were given intramuscularly
two months apart. The primary objective of this study is the
overall vaccine efficacy against shingles in people aged 50 years
or older, compared to placebo. The study includes subjects in the
age ranges 50-59, 60-69, 70-79, and ≥80 years.
About the phase III study programme
Involving more
than 37,000 subjects globally, the phase III programme for GSK's
candidate shingles vaccine evaluates its efficacy, safety and
immunogenicity. In addition to older adults, the candidate vaccine
is being evaluated in immunocompromised patient populations,
including solid and haematological cancer patients, haematopoietic
stem cell and renal transplant recipients and HIV-infected
people.
About shingles
Shingles typically presents as a
painful, itchy rash that develops on one side of the body, as a
result of reactivation of latent chickenpox virus (varicella zoster
virus, VZV). Anyone who has been infected with VZV is at risk of
developing shingles, with age and altered immune system being
recognised as the main risk factors3,4. Complications
from shingles can include PHN, (the most common
complication), scarring, vision complications, secondary
infection and nerve palsies3,4.PHN is often defined as a
localized pain of significant intensity persisting at least 90 days
after the appearance of the acute shingles rash4.
Data from many countries indicate that older adults (aged 50 and
over) are at highest risk for shingles as more than 90% of older
adults have been infected with wild type VZV3. A
person's risk for shingles increases sharply after 50 years of
age3. Risk of complications, including PHN and
hospitalisation, also increase with age3. The individual
lifetime risk of developing shingles is approximately one in three
for people in the USA; however,
for individuals aged 85 and over, this risk increases to one in two
people3,4.
References
- Cunningham et al., N Engl J Med 2016; 375: 1019-32. Efficacy of
the herpes zoster subunit vaccine in adults 70 years of age or
older.
- Lal et al., N Engl J Med 2015; 372:2087-2096 Efficacy of
an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults
- Shingles (Herpes Zoster) Clinical Overview. US Centers for
Disease Control and Prevention. Accessed at:
http://www.cdc.gov/shingles/hcp/clinical-overview.html on
6 Sept 2016.
- Cohen et al., N Engl J Med 2013;369:255-63 Clinical practice:
Herpes zoster.
- The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon® adjuvant licensed from Antigenics Inc, a wholly owned
subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes
GSK – one of the world's leading research-based
pharmaceutical and healthcare companies – is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com.
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statement regarding forward-looking statements GSK cautions
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company's Annual Report on Form 20-F for 2015.
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visit:http://www.prnewswire.com/news-releases/gsks-candidate-shingles-vaccine-shows-high-efficacy-against-shingles-and-its-complications-in-adults-aged-70-years-and-over-in-phase-iii-study-published-in-nejm-300328369.html
SOURCE GSK