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A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With HM Receiving Treatment With Anti-CD20 Monoclonal Antibodies (V212-013)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 25, 2011
Last updated: December 22, 2014
Last verified: December 2014
An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated Varicella-Zoster Virus (V212) vaccine in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies.

Condition Intervention Phase
Herpes Zoster
Biological: V212
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I, Open-Label, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies Receiving Treatment With Anti-CD20 Monoclonal Antibodies

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Geometric Mean Foldrise (GMFR) of the VZV-specific Immune Responses measured by VZV Interferon-gamma (IFN-g) ELISPOT [ Time Frame: Prevaccination to ~28 days Postdose 4 ]

Enrollment: 80
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V212 Arm
0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.
Biological: V212
V212 viral antigen for HZ, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Other Names:
  • Inactivated Varicella-Zoster (VZV) vaccine
  • Zostavax


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

Inclusion Criteria:

  • Diagnosed with a HM and is receiving treatment with anti-CD20 monoclonal antibodies and is not likely to undergo hematopoietic cell transplant (HCT).
  • Has a predicted life expectancy of ≥ 12 months.
  • Has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.
  • All female participants of childbearing potential must have a negative serum or urine pregnancy test.

Exclusion Criteria:

  • A history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
  • Prior history of HZ within 1 year of enrollment.
  • Prior receipt of any varicella or zoster vaccine.
  • Participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
  • Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.
  • Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
  • Participant is currently participating or has participated in a study with an investigational anti-CD20 monoclonal antibody within 3 months of signing informed consent.
  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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01460719     History of Changes
Other Study ID Numbers: V212-013
Study First Received: October 25, 2011
Last Updated: December 22, 2014

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents processed this record on March 23, 2017