GlaxoSmithKline (GSK) Announces New Shingrix Data at IDWeek

October 27, 2016 9:13 AM EDT

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GSK (NYSE: GSK) announced new data for its shingles candidate vaccine Shingrix, 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),1,2 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.

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.



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