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)

NCT ID: NCT01460719

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-24
• Study Completion Date: 2012-09-25

Brief Summary

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

V212

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.

Group Type: EXPERIMENTAL

V212

Intervention Type: BIOLOGICAL

V212 viral antigen for HZ

Interventions

V212

V212 viral antigen for HZ

Intervention Type: BIOLOGICAL

Other Intervention Names

Inactivated Varicella-Zoster (VZV) vaccine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 28268074 (View on PubMed)

Other Identifiers

V212-013

Identifier Type: OTHER

Identifier Source: secondary_id

2011-003153-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V212-013

Identifier Type: -

Identifier Source: org_study_id