Clinical trial NCT01460719: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-10-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT)
timeFrame: Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118)
measure: Percentage of Participants With an Adverse Event
timeFrame: Up to ~28 days after Vaccination 4 (~Day 118)
measure: Percentage of Participants With an Injection-site Adverse Event
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With a Systemic Adverse Event
timeFrame: Up to ~28 days after Vaccination 4 (~Day 118)
measure: Percentage of Participants With a Serious Adverse Event
timeFrame: Up to ~28 days after Vaccination 4 (~Day 118)
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event
timeFrame: Up to ~28 days after Vaccination 4 (~Day 118)
measure: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
timeFrame: Up to Vaccination 4 (~Day 90)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.