LONDON, June 21, 2017 /PRNewswire/ -- GSK (LSE/NYSE:
GSK) today will be presenting new results from a clinical study
showing that its candidate vaccine for the prevention of herpes
zoster (shingles) in people aged 50 years or older, Shingrix
(HZ/su), induces a strong immune response in older adults who have
previously been vaccinated against shingles with the currently
available live-attenuated zoster vaccine (ZVL). The results of the
Zoster-048 study will be presented today at the US Centers for
Disease Control and Prevention's Advisory Committee on Immunization
Practices (ACIP) meeting.
The study met its primary objective of demonstrating
non-inferior immune response (i.e. antibody concentrations). People
who received the ZVL vaccine at least 5 years prior to being
vaccinated with Shingrix showed a similar immune response to people
without previous exposure to the ZVL vaccine. In addition, Shingrix
was well-tolerated in both study groups when assessed up to one
month after the second dose of Shingrix.
GSK is sharing these data on safety, local and
systemic reactions, and immunogenicity with the US Food and
Drug Administration (FDA) and expects that the data could
eventually inform a policymaking decision regarding revaccination
for protection against shingles with Shingrix. The ongoing study of
430 adults aged 65 years and older was designed as a prospective,
group-matched, non-randomised, open-label, multicentre trial in
those previously vaccinated with ZVL at least 5 years earlier and
in previously unvaccinated subjects.
The current standard of care ZVL provides protection against
shingles, but studies suggest that this protection wanes over
time.1,2
Dr. Thomas Breuer, Senior Vice
President and Chief Medical Officer of GSK Vaccines said: "We
are encouraged by these results, which indicate that Shingrix can
be an option for adults over 50 years of age, who previously
received the currently available vaccine and are seeking to benefit
from revaccination with Shingrix, if recommended."
Zoster-048 is focused on the immune response and safety of
Shingrix, rather than efficacy, and builds on previously released
clinical trial data where the immunogenicity and efficacy were
tested simultaneously. The most common local and systemic reactions
were in line with previous observations and no clinically
significant safety signs were observed.
In two separate phase III studies, ZOE-50 and ZOE-70, Shingrix
demonstrated efficacy against shingles above 90%, independent of
age (>50, >70, >80 years of age), as well as sustained
efficacy over the entire follow-up period of 4
years.3,4
The study presented today has been submitted for publication in
a peer-reviewed scientific journal.
The candidate shingles vaccine, Shingrix, was submitted for
regulatory approval to the FDA in October
2016, to Canadian regulatory authorities and the European
Medicines Agency in November 2016,
and to Japanese regulatory authorities in April 2017. Shingrix is not currently approved
for use anywhere in the world.
About the Zoster-048 study
The prospective,
group-matched, non-randomised, open-label, multicentre Zoster-048
(NCT02581410) trial of 430 adults aged 65 years and older assessed
the safety, local and systemic reactions, and immunogenicity of
Shingrix in older adults (65 years and above) who have previously
been vaccinated against shingles with the currently available
live-attenuated zoster vaccine at least 5 years earlier and in
previously unvaccinated subjects.
The phase III programme, involving more than 37,000 subjects
globally, previously evaluated the efficacy, safety and immune
response of two doses of GSK's candidate shingles vaccine given
intramuscularly two months apart in older adults. Data from the
completed studies, ZOE-50 and ZOE-70, were previously presented to
the US Centers for Disease Control and Prevention's Advisory
Committee on Immunization Practices and published in a
peer-reviewed medical
journal.3,4
Additional trials are underway in solid and haematological
cancer patients, haematopoietic stem cell and renal transplant
recipients. These studies will provide additional information on
the candidate vaccine's safety and ability to stimulate immune
responses in populations at high risk of shingles because of the
weakening of their immune system.
About the candidate vaccine
The candidate vaccine is a
non-live, recombinant vaccine to help prevent herpes zoster
(shingles) and its complications and combines glycoprotein E, a
protein found on the varicella zoster virus (VZV), with an adjuvant
system, AS01B, which is intended to enhance the
immunological response to the antigen.5 The name
"Shingrix" has not yet been approved for use by any regulatory
authority.
Notes to editors
Zoster Vaccine Live (ZVL), Zostavax®, is a registered
trademark of Merck Sharpe & Dohme corp.
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 or VZV). Data from many countries indicates that more than
90% of adults have been infected with VZV during childhood. The
individual lifetime risk in the US of developing shingles is
approximately one in three; however, this increases to one in two
in people aged 85 and over. A person's risk for shingles increases
after 50 years of age due to a natural age-related decline in
immune system function.6
The most common complication from shingles is post-herpetic
neuralgia, defined as a localised pain of significant intensity
persisting at least 90 days after the appearance of the acute
shingles rash. Other complications of shingles include
ophthalmologic, neurological and cutaneous disease, which can
result in severe disability.7
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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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 'Principal risks and
uncertainties' in the company's Annual Report on Form 20-F for
2016.
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1 Morrison, et al. Clin Infect Dis. 2015 ;
60(6): 900-9. Long-term persistence of zoster vaccine efficacy.
2 Tseng, et al. J Infect Dis. 2016 ;
213(12): 1872-5. Declining Effectiveness of Herpes Zoster Vaccine
in Adults Aged ≥60 Years.
3 Lal, et al. N Engl J Med. 2015; 372: 2087-96.
Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older
Adults.
4 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.
5 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.
6 Harpaz, et al. MMWR Recomm Rep. 2008; 57(5):
1-30. Prevention of herpes zoster: recommendations of the Advisory
Committee on Immunization Practices.
7 Cohen, et al. N Engl J Med. 2013; 369(3):
255-63. Clinical practice: Herpes zoster.
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visit:http://www.prnewswire.com/news-releases/gsk-presents-positive-results-from-phase-iii-revaccination-study-of-its-candidate-shingles-vaccine-shingrix-at-cdcs-advisory-meeting-300477629.html
SOURCE GSK