Back to resultsA 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)
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V212
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
V212
Arm 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.
Outcomes
Primary Outcome Measures
Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT)
The VZV ELISPOT assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC on Day 1.
Percentage of Participants With an Adverse Event
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any AE was summarized.
Percentage of Participants With an Injection-site Adverse Event
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any injection-site AE was summarized.
Percentage of Participants With a Systemic Adverse Event
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any systemic AE was summarized.
Percentage of Participants With a Serious Adverse Event
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized.
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized.
Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized.
Secondary Outcome Measures
Full Information
NCT ID
NCT01460719
First Posted
October 25, 2011
Last Updated
November 15, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01460719
Brief Title
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 24, 2012 (Actual)
Primary Completion Date
September 25, 2012 (Actual)
Study Completion Date
September 25, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V212
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
V212
Other Intervention Name(s)
Inactivated Varicella-Zoster (VZV) vaccine
Intervention Description
V212 viral antigen for HZ
Primary Outcome Measure Information:
Title
Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT)
Description
The VZV ELISPOT assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC on Day 1.
Time Frame
Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118)
Title
Percentage of Participants With an Adverse Event
Description
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any AE was summarized.
Time Frame
Up to ~28 days after Vaccination 4 (~Day 118)
Title
Percentage of Participants With an Injection-site Adverse Event
Description
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any injection-site AE was summarized.
Time Frame
Up to 5 days after any vaccination
Title
Percentage of Participants With a Systemic Adverse Event
Description
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any systemic AE was summarized.
Time Frame
Up to ~28 days after Vaccination 4 (~Day 118)
Title
Percentage of Participants With a Serious Adverse Event
Description
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized.
Time Frame
Up to ~28 days after Vaccination 4 (~Day 118)
Title
Percentage of Participants With a Vaccine-related Serious Adverse Event
Description
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized.
Time Frame
Up to ~28 days after Vaccination 4 (~Day 118)
Title
Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
Description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized.
Time Frame
Up to Vaccination 4 (~Day 90)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
28268074
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.
Results Reference
result
Learn more about this trial
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)
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