New data on shingles candidate vaccine Shingrix was presented at the Infectious Disease Week (ID Week) scientific conference in New Orleans, USA, this week.
The data on Shingrix, which is being developed by GSK, examined co-administration of it with the flu vaccine, a flexible dosing schedule and the vaccine’s impact on quality of life.
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 about 1 in 3 for people in the USA; however, this increases to 1 in 2 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.
Using subjects from two multicentre, multinational studies from the global phase III candidate vaccine clinical programme, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229), Shingrix’s impact on quality of life was analysed. Due to the high efficacy across all ages in these two pivotal trials, as expected, only a few subjects in the vaccines arm developed “breakthrough” shingles after vaccination. 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 2-6 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 on 24 October. 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 at 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. [This] 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.”
ID Week is the combined annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.