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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Herpes Zoster

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Geometric Mean Foldrise (GMFR) of the VZV-specific Immune Responses measured by VZV Interferon-gamma (IFN-g) ELISPOT

Outcome Time Frame:

Prevaccination to ~28 days Postdose 4

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

V212-013

NCT ID:

NCT01460719

Start Date:

January 2012

Completion Date:

September 2012

Related Keywords:

  • Herpes Zoster
  • Chickenpox
  • Herpes Zoster

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