A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Herpes Zoster

Treatments: Biological: V212

Study type: Interventional

Funder types: Industry

Identifiers

NCT01460719

V212-013 (Other Identifier)

2011-003153-25 (EudraCT Number)

Details and patient eligibility

About

An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at ~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is >1.0.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

V212

Experimental group

Description:

Participants receive V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.

Treatment:

Biological: V212