GlaxoSmithKline plc said new data supports the safety and efficacy of Shingrix in preventing shingles in patients who have undergone a transplant of their own hematopoietic stem cells.
In the phase 3 Zoe-HSCT study, Shingrix met the main goal by showing efficacy of 68.17% against shingles in patients above 18 years old, after receiving an autologous hematopoietic stem cell transplant. The drug showed similar effectiveness, 67.34%, in patients who are at least 50 years old.
The vaccine also reduced shingles-related complications by 77.67%. Vaccine efficacy for the prevention of post-herpetic neuralgia, a common form of shingles-related chronic nerve pain, was 89.27%. No safety issues were seen during the study.
The Zoe-HSCT study enrolled 1,846 subjects who were randomized 1:1 to receive either Shingrix or placebo.
Shingrix is approved in Canada and U.S. for the prevention of herpes zoster in adults aged 50 years and above. The vaccine is under review in the EU, Australia, and Japan.
Shingles is caused by the reactivation of the varicella zoster virus, the virus which causes chickenpox. There are about 1 million cases of shingles in the U.S. each year.
