Merck’s inactivated varicella zoster virus vaccine (VZV), V212, has met its primary endpoint in the first phase III study.
V212 is the firm’s investigational inactivated VZV vaccine to prevent herpes zoster (HZ) and HZ-related complications in immunocompromised subjects with the age of 18 years and above.
The company has designed double-blind, randomized, placebo-controlled and multi-center trial to evaluate safety, tolerability, efficacy and immunogenicity of inactivated VZV vaccine in recipients of autologous hematopoietic stem cell transplants (auto-HSCT).
According to the company, the trial reduced the incidence of confirmed HZ cases by an estimated 64% in recipients of auto-HSCT.
The study’s secondary endpoint findings demonstrated that V212 reduced the incidence of moderate-to-severe HZ pain by about 69.5% based on the Zoster brief pain inventory (ZBPI) score.
With a history of varicella infection or seropositive for VZV antibody, the trial is comprised of patients 18 years or older undergoing auto-HSCT for malignancy or any other indication.
The company has completed the phase 3 trial in auto-HSCT recipients, and is continuing another phase 3 trial in subjects with malignancies is ongoing.
Zostavax is a live attenuated virus vaccine developed to prevent herpes zoster (shingles) in individuals 50 years of age and older. It is not indicated for the treatment of zoster or postherpetic neuralgia.
Merck Research Laboratories senior vice president Dr Eliav Barr said: “Patients undergoing auto-HSCT have an increased risk of HZ and associated complications due to impaired cellular immunity.
“These results indicate that V212 might offer a way to help reduce the risk of HZ and HZ-related complications in this vulnerable, immunocompromised patient population.”
Image: Merck’s first phase III study of V212 has reduced the incidence confirmed HZ cases by an estimated 64% in recipients of auto-HSCT. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.