TIDMGSK
RNS Number : 5260L
GlaxoSmithKline PLC
28 April 2015
Issued: Tuesday 28 April 2015, London UK, LSE Announcement
GSK candidate vaccine for the prevention of shingles
demonstrates overall efficacy of 97.2% which does not diminish in
the age groups studied
- Shingles is a significant public health burden, more than 90
per cent of adults aged 50 years and over are at
risk[i](,[ii],vi)
GlaxoSmithKline plc (LSE/NYSE: GSK) today presented detailed
data from a randomised phase III study of its investigational
vaccine candidate for the prevention of shingles, HZ/su, showing
vaccine efficacy was maintained across age groups, from 50 years to
70 years and over. The data was presented at the 25th Scientific
Congress of the European Society of Clinical Microbiology and
Infectious diseases (ECCMID) in Copenhagen and published online
simultaneously in the New England Journal of Medicine.
Analysis of the primary endpoint showed that a two-dose schedule
of HZ/su reduced the risk of herpes zoster by 97.2% (95% confidence
interval [CI] 93.7-99.0) in adults aged 50 years and older compared
to placebo. Vaccine efficacy was maintained across the various age
groups included in the study, ranging between 96.6% in people aged
50-59 years, 97.4% in those aged 60-69 years, 97.6% in people aged
60 years and above, and 98% in those 70 years or older. There was
no significant difference in vaccine efficacy among the age
groups.
The proportions of subjects with serious adverse events,
potential immune-mediated diseases, or deaths were similar in
vaccine and placebo groups. The most commonly reported local
adverse reaction was pain with the others being redness and
swelling at the injection site. These were graded severe in 9.5% of
HZ/su recipients compared to 0.4% of placebo recipients. The more
frequently reported systemic adverse reactions were muscle pain,
fatigue and headache, of which 11.4% were graded severe in the
HZ/su group compared to. 2.4% in the placebo group. These reactions
mostly occurred within 7 days of vaccination with most lasting 1-3
days.
The HZ/su candidate vaccine is non-live and combines gE, a
protein found on the virus that causes shingles, with an adjuvant
system, AS01(B) ,[iii] which is intended to enhance the
immunological response to gE.
Additional trials to evaluate the ability of HZ/su to prevent
shingles are ongoing in people aged 70 and older and in adults with
compromised immune systems. These studies will provide additional
information with respects to the safety of HZ/su and its ability to
stimulate immune responses in specific populations. These studies
will also address the degree to which HZ/su can prevent
complications of shingles, such as chronic neuropathic pain, also
known as post-herpetic neuralgia (PHN).[iv]
Dr Moncef Slaoui, Chairman Global Vaccines at GSK, said: "We are
extremely encouraged that the results may point out a health
benefit in the prevention of shingles. This disease can be painful
and potentially debilitating for some people and older people are
particularly at risk. We look forward to continuing the development
of our Zoster programme"
Notes to editors
About the ZOE-50 trial
The ZOE-50 (Zoster efficacy in adults aged 50 years and
over))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 and reported headline efficacy data in December 2014. Doses
were given intramuscularly on a 2-dose schedule at 0 and 2 months.
The primary endpoint of this study is the overall vaccine efficacy
(VE) of the candidate vaccine HZ/su across all age cohorts compared
to placebo in reducing the risk of developing shingles. The study
includes subjects in the age ranges 50-59, 60-69, 70-79, and (3)80
years.
About the phase III HZ/su study programme
Involving more than 37,000 subjects globally, the phase III
programme for candidate vaccine HZ/su will evaluate its efficacy,
safety and immunogenicity. In addition to older adults, HZ/su 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
factors.(vi) Complications from shingles can include PHN, (the most
common complication).(iv,) scarring, vision complications,
secondary infection and nerve palsies.
Data from many countries indicate that older adults (aged 50 and
over) are at risk of Herpes zoster since more than 90 per cent have
been infected with wild type VZV ,[v](,) . A person's risk for
shingles increases sharply after 50 years of age. Risk of
complications, including PHN and hospitalisation, also increase
with age. The individual lifetime risk of developing HZ is
approximately one in three people; however, for individuals aged 85
and over, this risk increases to one in two people.[vi]
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.
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.
GSK enquiries:
UK Media enquiries: David Mawdsley +44 (0) 20 8047 (London)
5502
Simon Steel +44 (0) 20 8047 (London)
5502
David Daley +44 (0) 20 8047 (London)
5502
Catherine Hartley +44 (0) 20 8047 (London)
5502
Sarah Spencer +44 (0) 20 8047 (London)
5502
Claire Brough +44 (0) 20 8047 (London)
5502
US Media enquiries: Sarah Alspach +1 202 715 1048 (Washington,
DC)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Melinda Stubbee +1 919 483 2510 (North Carolina)
Jenni Ligday +1 202 715 1049 (Washington,
DC)
Karen Hagens +1 919 483 2863 (North Carolina)
Analyst/Investor Ziba Shamsi +44 (0) 20 8047 (London)
enquiries: 5543
Tom Curry + 1 215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 (London)
5503
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F
for 2014.
References
[i] Shingles (Herpes Zoster) Clinical Overview. US Centers for
Disease Control and Prevention, May 1(st) 2014. Accessed at:
http://www.cdc.gov/shingles/hcp/clinical-overview.html on 15th
April 2015.
[ii] Sadzot-Delvaux, et al., 2008; JID (suppl). 197:S185
The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon(R) adjuvant licensed from Antigenics Inc, a wholly owned
subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes
Johnson, RW et al N Engl J Med 2014;371:1526-33
[v] Shingles (Herpes Zoster) Clinical Overview. US Centers for
Disease Control and Prevention, May 1(st) 2014. Accessed at:
http://www.cdc.gov/shingles/hcp/clinical-overview.html on 15th
April 2015.
[vi] S. Pinchinat et al: Similar herpes zoster incidence across
Europe: results from a systematic literature review. BMC Infectious
Diseases 2013, 13:170
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