Phase 3
N=5,285
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)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT01254630 ↗Enrolled (actual)
5,285
Serious AEs
50.0%
Results posted
Apr 2018
Primary outcome: Primary: Incidence of Confirmed Herpes-Zoster — 6.737; 18.457 Number of cases per 1000 person years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V212 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Confirmed Herpes-Zoster |
6.737; 18.457 | — |
| PRIMARY Percentage of Participants With One or More Serious Adverse Events |
22.5; 21.0 | — |
| SECONDARY Incidence of Moderate to Severe Herpes-Zoster-Associated Pain |
2.144; 9.380 | — |
| SECONDARY Incidence of Herpes-Zoster Complications |
0.306; 2.421 | — |
| SECONDARY Incidence of Postherpetic Neuralgia |
0.306; 1.210 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01254630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.