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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01229267
First received: October 25, 2010
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Herpes Zoster
Biological: V212
Biological: Matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of herpes zoster (HZ) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
    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:
  • Incidence of moderate to severe HZ-associated pain [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: No ]
    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]),

  • Incidence of HZ complications [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
    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.

  • Incidence of postherpetic neuralgia (PHN) [ Time Frame: Onset of HZ rash up to 6-month follow-up ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1204
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01229267     History of Changes
Other Study ID Numbers: V212-001
Study First Received: October 25, 2010
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014