TIDMGSK
RNS Number : 6421N
GlaxoSmithKline PLC
27 October 2016
Issued: 27 October, London UK
GSK presents new data for shingles candidate vaccine at IDWeek
scientific conference
- New studies support flexible dosing and co-administration with flu vaccine
GSK today announced new data for its shingles candidate vaccine
Shingrix(TM) , at the Infectious Disease Week (IDWeek) scientific
conference in New Orleans, Louisiana, USA. The data examined
co-administration of GSK's candidate vaccine with the flu vaccine;
a flexible dosing schedule; and the vaccine's impact on quality of
life.
Summary of new data
(--) Using subjects from two multicentre, multinational studies
from the global phase III candidate vaccine clinical programme,
ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229), the vaccine's impact
on quality of life was analysed. Due to the high efficacy across
all ages in these two pivotal trials, only a few subjects in the
vaccines arm developed "breakthrough" shingles after vaccination,
as expected. Using an established standard health survey, those who
had developed shingles reported reduced levels of pain compared to
the group that did not receive the vaccine. The study concluded
that in addition to helping prevent shingles, the candidate vaccine
also reduced the severity of shingles in the few patients who
developed the disease after vaccination.
(--) In the phase III clinical trial programme, adults aged 50
years or over received two doses of the candidate vaccine two
months apart. A new study (ZOSTER-026) of 354 patients showed that
the second dose of the vaccine could be administered during a
window of two to six months following the first dose, with a
similar level of immune response and comparable safety profile.
(--) A study (ZOSTER-004) conducted during the 2013 Northern
Hemisphere flu season with adults aged 50 years or over showed that
when the candidate vaccine was given to patients at the same time
as an unadjuvanted seasonal flu vaccine, both vaccines were well
tolerated and the immune response to each vaccine was similar
whether it was administered at the same time or separately.
Across the clinical trial programme, the risk of serious adverse
events, potential immune-mediated diseases or deaths observed 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 intensity.
GSK included data on flexible dosing and co-administration with
unadjuvanted seasonal flu vaccine in its regulatory file submission
to the United States Food and Drug Administration (FDA) on Monday
24 October 2016. Data will also be part of the licensure
applications in other parts of the world, which are planned later
this year.
Dr Thomas Breuer, Chief Medical Officer GSK Vaccines said:
"Shingles is a common but serious condition that results from the
reactivation of the virus that causes chicken pox. The risk of
getting shingles increases sharply after 50 years of age. GSK's
shingles candidate vaccine has consistently shown high efficacy in
older people in its phase III development programme. This
underscores the potential impact of this novel vaccine candidate to
help prevent shingles, and to help overcome the challenge of
decreasing immunity that comes with age. Today's new data further
support the vaccine candidate's profile in helping to prevent
shingles and improve quality of life, and provide new evidence to
support flexible dosing options."
IDWeek is the combined annual meeting of the Infectious Diseases
Society of America (IDSA), the Society for Healthcare Epidemiology
of America (SHEA), the HIV Medicine Association (HIVMA), and the
Pediatric Infectious Diseases Society (PIDS). In addition to
presenting data about shingles, GSK will also be presenting
abstracts on improving the prevention of influenza through
vaccination.
About Shingrix
The candidate vaccine is a non-live, recombinant vaccine to help
prevent herpes zoster and its complications and combines
glycoprotein E, a protein found on the varicella zoster virus (VZV)
that causes shingles, with an adjuvant system, AS01(B) , which is
intended to enhance the immunological response to the antigen(3) .
GSK intends to register the product as Shingrix(TM) , subject to
approval by relevant regulatory review bodies. The name Shingrix is
not yet approved for use by regulatory authorities in any
country.
Additional trials to evaluate the ability of the vaccine
candidate to help prevent shingles are ongoing in older adults 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 in an
immunocompromised population as well as its ability to stimulate
immune responses in other populations and in specific
circumstances.
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 the Zoster-026 study
In this study, two doses of the candidate vaccine were
administered two, six or 12 months apart. Immune response and
safety profile after these alternative dose schedules were
compared.
About the Zoster-004 study
In this study, quadrivalent inactivated seasonal influenza
vaccine was given at the same time as the first dose of the vaccine
candidate, or both vaccines were given sequentially. Immune
response and safety profile were compared.
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 varicella during childhood. The individual lifetime
risk of developing shingles is approximately one in three for
people in the USA; however, this increases to one in two people
aged 85 and over. A person's risk for shingles increases sharply
after 50 years of age due to a natural age-related decline in
immune system function, or as a consequence of an underlying
immunocompromising condition.(4)
The most common complication from shingles is post-herpetic
neuralgia, defined as 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.(5)
References
1. 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.
2. Lal et al., N Engl J Med 2015; 372:2087-2096 Efficacy of an
Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults
3. 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.
4. Cohen et al., N Engl J Med 2013;369:255-63 Clinical practice: Herpes zoster.
5. The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon(R) adjuvant licensed from Antigenics LLC, 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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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
2015.
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