VZV Vaccine Promising in Immunocompromised Patients With Herpes Zoster
V212 is Merck’s investigational inactivated VZV vaccine for the prevention of Herpes Zoster in immunocompromised patients.
Merck has announced positive results from a Phase 3 trial (ClinicalTrials.gov identifier: NCT01229267) of V212, an investigational varicella zoster virus vaccine (VZV) for the prevention of herpes zoster (HZ) in immunocompromised patients.
There were 1,230 individuals enrolled (≥18 years old) in the trial, all undergoing hematopoietic stem cell transplants (auto-HSCT). Subjects were randomized to receive a 4-dose regimen of V212 from a consistency lot, a high-antigen lot, or placebo. The patients were followed for an average of 2.6 years post vaccination with cases of HZ confirmed by polymerase chain reaction and/or adjudicated by a blinded data monitory committee.
Results showed that V212 met its primary endpoint of reduction in the incidence of confirmed HZ cases by an estimated 64% (95% CI, 0.48, 0.75) in recipients of auto-HSCT. Moderate-to-severe HZ pain also was reduced by an estimated 69.5%, using the Zoster Brief Pain Inventory (ZBPI) score. Other complications, such as hospitalization, disseminated HZ, visceral HZ, ophthalmic HZ, neurological impairment due to HZ, were down by an estimated 73.5%.
The live zoster vaccine, Zostavax (Merck), is approved for those ≥50 years of age and is contraindicated in patients who are immunocompromised. As all individuals receiving auto-HSCT are immunocompromised, if approved, V212 could help reduce the risk of HZ and related complication in this patient population.
Serious adverse events occurred in 32.9% of patients receiving the consistency lot or high-antigen lot and in 32.7% of patients receiving placebo for up to 28 days after the fourth vaccination dose. The most frequent serious adverse event observed was febrile neutropenia in 5.3% of the vaccine group and 4.9% in the placebo group.
For more information visit Merck.com.
In first phase 3 trial, Merck's investigational inactivated varicella zoster virus vaccine (V212) reduced the incidence of confirmed herpes zoster cases by an estimated 64 percent in immunocompromised subjects [news release]. Kenilworth, NJ: Merck & Co., Inc. Published February 24, 2017. Accessed March 8, 2017.