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.
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.
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.
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.
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.
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.
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.
In this study, quadrivalent inactivatedseasonal 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.
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.
