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Trial record 1 of 8 for:    v212
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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460719
First Posted: October 27, 2011
Last Update Posted: April 18, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
October 25, 2011
October 27, 2011
April 18, 2017
January 24, 2012
September 25, 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01460719 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Herpes Zoster
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
Experimental: V212 Arm
0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.
Intervention: Biological: V212
Parrino J, McNeil SA, Lawrence SJ, Kimby E, Pagnoni MF, Stek JE, Zhao Y, Chan IS, Kaplan SS. Safety and immunogenicity of inactivated varicella-zoster virus vaccine in adults with hematologic malignancies receiving treatment with anti-CD20 monoclonal antibodies. Vaccine. 2017 Mar 27;35(14):1764-1769. doi: 10.1016/j.vaccine.2016.10.055. Epub 2017 Mar 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 25, 2012
September 25, 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   Estonia,   France,   Israel,   Puerto Rico,   Spain,   Sweden,   Thailand,   United States
 
NCT01460719
V212-013
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP