A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: V212; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254630

V212-011 (Other Identifier)

CTRI/2012/05/002673 (Registry Identifier)

2010-023156-89 (EudraCT Number)

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) receiving chemotherapy and to assess the impact of V212 on the development of herpes zoster (HZ) in adults with STM receiving chemotherapy. The primary hypothesis is that vaccination with V212 will reduce the incidence of HZ compared with placebo in adults with STM (lower bound of the 97.5% {one-sided α=0.0125} confidence interval [CI] for the estimated vaccine efficacy in adults with STM be >25%).

Participants with hematologic malignancy (HM) were also enrolled and were to be originally included in the primary and secondary objectives and analyses. After an interim analysis demonstrated clear evidence of futility of V212 in the HM population, enrollment of this population was stopped and all HM-related objectives and analyses were made exploratory and are not reported in this record.

Enrollment: 5,305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and is either ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen OR is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not
• Life expectancy ≥12 months
• Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is <30 years old, attended primary or secondary school in a country with endemic VZV infection
• Is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose
• Female participants of childbearing potential must have a negative serum or urine pregnancy test

Exclusion criteria

• History of hypersensitivity reaction to any vaccine component
• Prior history of Herpes Zoster within 1 year of enrollment
• Has received or is expected to receive any varicella or non-study zoster vaccine
• Currently receiving or expected to receive long-term antiviral prophylaxis (>4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV)
• Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months from last vaccination dose
• Has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4
• Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

5,305 participants in 4 patient groups, including a placebo group

V212-STM

Experimental group

Description:

Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.

Treatment:

Biological: V212

V212-HM

Experimental group

Description:

Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.

Treatment:

Biological: V212

Placebo-STM

Placebo Comparator group

Description:

Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.

Treatment:

Biological: Placebo

Placebo-HM

Placebo Comparator group

Description:

Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.

Treatment:

Biological: Placebo