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
- 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
- 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