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GSK’s shingles vaccine Shingrix succeeds in phase 3 revaccination trial

PBR Staff Writer Published 22 June 2017

GSK’s shingles vaccine candidate Shingrix (HZ/su) met its primary objective of inducing a strong immune response in older patients in a phase 3 revaccination trial.

Shingrix is being developed for the prevention of shingles, better known than herpes zoster, a painful, itchy rash condition caused by reactivation of latent chickenpox virus.

The vaccine candidate was shown to have yielded positive results in patients who were previously vaccinated with the currently available live-attenuated zoster vaccine (ZVL) for shingles prevention.

The phase 3 trial dubbed as Zoster-048 study showed that patients who had been vaccinated with ZVL at least five years before being subjected to Shingrix vaccine had registered a similar immune response to people who did not take ZVL vaccination before.

Additionally, GSK says that its vaccine candidate, Shingrix was well-tolerated in the two study arms when evaluated up to one month after its second dose.

GSK Vaccines senior vice president and chief medical officer Dr. Thomas Breuer said: “We are encouraged by these results, which indicate that Shingrix can be an option for adults over 50 years of age, who previously received the currently available vaccine and are seeking to benefit from revaccination with Shingrix, if recommended.”

According to the pharma giant, Zoster-048 is focused on the immune response and safety of the vaccine candidate and not on its efficacy. The phase 3 results it says add to the previous clinical trial data in which the immunogenicity and efficacy were assessed simultaneously.

GSK also revealed that the most common local and systemic reactions were as expected as with past observations and no significant safety signs in the clinical trial were observed.