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 Participants Undergoing Hematopoietic Cell Transplants (HCTs) (Study No. V212-001 AM4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229267
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: V212 Biological: Matching placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)
Study Start Date : November 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: V212
V212 (inactivated VZV)
Biological: V212
0.5-mL subcutaneous injection administered ~30days (60 to 5 days) prior to HCT. Doses 2 through 4 will be administered 30, 60 and 90 days post-HCT.
Other Name: Inactivated Varicella-Zoster (VZV) vaccine

Placebo Comparator: Placebo
Matching placebo
Biological: Matching placebo
0.5-mL subcutaneous injection administered ~30days (60 to 5 days) prior to HCT. Doses 2 through 4 will be administered 30, 60 and 90 days post-HCT.

Primary Outcome Measures :
  1. Incidence of herpes zoster (HZ) [ Time Frame: Approximately 3 years ]
    Incidence is defined as the number of HZ cases per 1000 person-years of follow-up from study enrollment to the end of study.

Secondary Outcome Measures :
  1. Incidence of moderate to severe HZ-associated pain [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ]
    Moderate to severe HZ-associated pain (defined as 2 or more occurrences of a score of 3 or greater (0-to-10 scale) on the Zoster Brief Pain Inventory [ZBPI]),

  2. Incidence of HZ complications [ Time Frame: Approximately 3 years ]
    HZ complications defined as the occurrence of any of the following during the study: 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.

  3. Incidence of postherpetic neuralgia (PHN) [ Time Frame: Onset of HZ rash up to 6-month follow-up ]
    Postherpetic neuralgia (PHN) is defined as a worst pain score [in the last 24 hours] of 3 or greater [0-to-10 scale] on the Zoster Brief Pain Inventory (ZBPI) that persists or appears greater than or equal to 90 days after the onset of the HZ rash

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women at least 18 years of age
  • 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.
  • Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of enrollment
  • 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
  • Prior receipt of any varicella or zoster vaccine
  • More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma may have had more than 2 relapses)
  • Expectation of tandem transplant procedure
  • Is expected to receive >6 months (>180 days) of prophylactic antiviral therapy post-HCT.
  • Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01229267     History of Changes
Other Study ID Numbers: V212-001
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Merck Sharp & Dohme Corp.:
Herpes zoster
herpes zoster-related complications
autologous hematopoietic cell transplants

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs