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GSK phase III study supports safety & efficacy of Shingrix in preventing shingles in auHSCT patients

London, UK
Thursday, December 7, 2017, 15:15 Hrs  [IST]

GlaxoSmithKline has announced that new data from a phase III clinical study supports the safety and efficacy of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) in preventing shingles (herpes zoster) when given to adults 18 years and above shortly after undergoing autologous haematopoietic stem cell transplant (auHSCT). Shingrix is a non-live, recombinant adjuvanted subunit vaccine given intramuscularly in two doses.

The ZOE-HSCT study succeeded in its primary objective by demonstrating an efficacy of 68.17% [95%CI: 55.56 - 77.53] against shingles in subjects above 18 years of age after receiving an autologous haematopoietic stem cell transplant. In subjects aged 50 and above, the efficacy was similar, 67.34% [95% CI: 52.60 - 77.89]. The vaccine reduced overall complications linked to shingles episodes by 77.76% [95% CI: 19.05% - 95.93%]. Vaccine efficacy for the prevention of post-herpetic neuralgia, a form of chronic nerve pain and the most common complication associated with shingles, was 89.27% [95% CI: 22.54–99.76]. No safety issues related to the vaccine were detected during the study.

“The immune systems of these stem cell transplant recipients is substantially weakened compared to the general older adult populations studied in other Shingrix efficacy trials,” Emmanuel Hanon, senior vice president and head of Vaccines R&D for GSK said. “This puts them at much higher risk for viral diseases like shingles and, at the same time, makes developing an effective vaccine to help protect them more challenging.”

“The results, demonstrating the vaccine’s ability to help prevent shingles and its complications with just two doses, may provide a much-needed benefit to these patients considering the high incidence and burden of disease they face,” he said.

Shingrix is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.

GSK is evaluating these results together with those of other phase III studies in immune-compromised patient populations. All these data will be shared and discussed with regulatory as well as public health agencies with the objective of best informing health care providers on the use of Shingrix in those patients with greatest medical need.

Shingrix is now approved in Canada and US for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan.

ZOE-HSCT was a phase III clinical study to evaluate the efficacy, safety and immunogenicity of a two-dose course of Shingrix for prevention of shingles (herpes zoster) when given to adults 18 years and above with the first dose administered 50-70 days after they had undergone autologous haematopoietic stem cell transplant (auHSCT). Study participants were randomized 1:1 to receive either Shingrix or placebo.

The study started in July 2012 and enrolled 1846 subjects in 28 countries worldwide spanning the North and South America, Europe, Africa, Asia and Oceania.

The safety profile of the vaccine was found to be clinically acceptable in this study. Overall, the proportion of severe adverse events (SAEs), fatal SAEs, potential immune-mediated diseases (pIMDs) and relapses (of the underlying disease) was similar between groups. Observations regarding reactogenicity were in line with the observations in previous studies.

This is the first time that Shingrix efficacy has been evaluated in immune-compromised patients such as those who have received auHSCT and who are at higher risk of developing shingles and its complications. These data complement the available efficacy results from ZOE-50 and ZOE-70 generated in adults aged 50 years and older.

Previously the only available shingles vaccine was live attenuated and therefore contra-indicated for those with weakened immunity. Developing an effective vaccine for these patients was an area of unmet medical need.

 

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