Clinical Trials

Date: 2017-02-24

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the combined annual meetings of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT

Company: Merck&Co (USA - NJ)

Product: V212

Action mechanism:

vaccine. V212 is an investigational inactivated VZV vaccine for the prevention of HZ and HZ-related complications in immunocompromised subjects age 18 years and above. 

Disease: herpes zoster

Therapeutic area: Infectious diseases

Country: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Israel, Italy, Republic of, Korea Lithuania, Mexico, Netherlands, Panama, Peru, Portugal, Puerto Rico, Russian Federation, Spain, Sweden, UK, USA

Trial details:

This is a study to determine whether investigational V212 reduces the incidence of herpes zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic cell transplants (HCT). Eligible subjects (n=1,230) were randomly assigned to receive a 4-dose regimen of V212 from a consistency lot (a lot having a targeted potency as required by regulators in order to demonstrate that the vaccine can be manufactured consistently), a high-antigen lot (a lot having a higher antigen potency added to assess further the safety profile of V212), or placebo. Randomization was stratified by age (younger than 50 years vs. older than 50 years) and by intended duration of post-transplant antiviral prophylaxis (?3 months vs. >3 to 6 months). Dose 1 of V212 or placebo was given within approximately 30 days before auto-HSCT, and doses 2, 3, and 4 were given approximately 30, 60, and 90 days after auto-HSCT. Subjects were followed for the duration of the study for efficacy with cases of HZ confirmed by PCR and/or adjudicated by a blinded data monitoring committee. The average follow-up time for HZ surveillance was approximately 2.3 years (median: 2.6 years) post vaccination. (NCT01229267)

Latest news:

* On February 24, 2017, Merck&Co announced the first Phase 3 study results for V212, the company’s investigational inactivated varicella zoster virus vaccine (VZV) for the prevention of herpes zoster in immunocompromised patients. This was a double-blind, randomized, placebo-controlled, multi-center trial to study safety, tolerability, efficacy and immunogenicity of inactivated VZV Vaccine in recipients of autologous hematopoietic stem cell transplants (auto-HSCT). In the trial, V212 met its primary endpoint and reduced the incidence of confirmed HZ cases by an estimated 64 percent (95% CI, 0.48, 0.75) in recipients of auto-HSCT. Secondary endpoint findings from the study showed that V212 reduced the incidence of moderate-to-severe HZ pain by an estimated 69.5 percent, utilizing the Zoster Brief Pain Inventory (ZBPI) score. V212 demonstrated an estimated 83.7 percent reduction of the incidence of post-herpetic neuralgia (PHN) beyond 90 days after onset of HZ. In the study PHN was defined as pain in the area of the HZ rash with a “worst pain in the last 24 hours” score of 3 or greater (on a 0 to 10 scale) on the ZBPI that persists or appears 90 days or beyond after HZ rash onset following auto-HSCT.

In addition, V212 showed reduction of other HZ complications by an estimated 73.5 percent. These other complications included hospitalization or prolongation of hospitalization due to HZ; disseminated HZ (including disseminated HZ rash or VZV viremia); visceral HZ, ophthalmic HZ; neurological impairment due to HZ; or administration of intravenous acyclovir therapy for treatment of HZ post auto-HSCT. These results were presented, as an oral presentation, at the combined annual meetings of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT) during a “Best Abstracts” session in Orlando, Florida. Merck&Co is currently reviewing the results of an additional Phase 3 study that is underway in immunocompromised patients with malignancies.



Is general: Yes