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)

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: NCT01460719
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : April 18, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Herpes Zoster Biological: V212 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : January 24, 2012
Actual Primary Completion Date : September 25, 2012
Actual Study Completion Date : September 25, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

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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:

  • 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.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01460719     History of Changes
Other Study ID Numbers: V212-013
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

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