Phase III data on Shingrix vaccine shows efficacy for Shingles in co-administration with flu vaccine- GlaxoSmithKline

GlaxoSmithKline has announced new data for its shingles candidate vaccine Shingrix, examining 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.

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. Data were presented at the Infectious Disease Week (IDWeek) scientific conference in New Orleans, Louisiana, USA.