Back to resultsA Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
V212
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster focused on measuring Shingles
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with an autoimmune disease
- Clinically stable disease for at least 30 days before enrollment
- Not likely to undergo hematopoietic stem cell transplantation during the study period
- Receiving at least one parenteral or oral biologic agent, such as a Tumor Necrosis factor (TNF) alpha inhibitor, or a parenteral or oral non-biologic therapy, at a stable dose for at least 3 months, with no planned or anticipated changes
- History of varicella, antibodies to VZV, or residence for at least 30 years in a country with endemic VZV infection, or if participant is less than 30 years old, attended primary or secondary school in a country with endemic VZV infection
Exclusion Criteria:
- Prior history of Herpes Zoster (shingles) within 1 year before enrollment
- Prior varicella or zoster vaccine
- Active central nervous system lupus erythematosus requiring therapeutic intervention within 90 days of enrollment
- Prior or planned therapy containing rituximab or other anti-Cluster of Differentiation (CD) 20 monoclonal antibodies from 3 months before enrollment through 28 days postdose 4
- Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the time of enrollment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
V212
Placebo
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.
Participants receive placebo 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) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
Serum samples were tested for antibody response using a gpELISA. The GMFR is response at approximately 28 days postdose 4 / response predose on Day 1.
GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
Serum samples were tested for activity using a VZV ELISPOT assay. The 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 predose on Day 1.
Percentage of Participants With a Serious Adverse Event
A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAE was assessed.
Secondary Outcome Measures
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs were erythema, pain, and swelling. The percentage of participants with one or more VRC-prompted injection-site AE was assessed.
Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card
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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and HZ-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed.
Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card
Elevated temperature is defined as ≥100.4 °F (≥38.0 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.
Full Information
NCT ID
NCT01527383
First Posted
January 16, 2012
Last Updated
January 10, 2019
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01527383
Brief Title
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
Official Title
A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2012 (Actual)
Primary Completion Date
February 26, 2013 (Actual)
Study Completion Date
February 26, 2013 (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
This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at approximately 28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine 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
Keywords
Shingles
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
354 (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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo 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
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator to V212 vaccine
Primary Outcome Measure Information:
Title
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
Description
Serum samples were tested for antibody response using a gpELISA. The GMFR is response at approximately 28 days postdose 4 / response predose on Day 1.
Time Frame
Baseline and ~28 days after Vaccination 4 (~Day 118)
Title
GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
Description
Serum samples were tested for activity using a VZV ELISPOT assay. The 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 predose on Day 1.
Time Frame
Baseline and ~28 days after Vaccination 4 (~Day 118)
Title
Percentage of Participants With a Serious Adverse Event
Description
A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAE was assessed.
Time Frame
Up to ~28 days after Vaccination 4 (~Day 118)
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
Description
An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs were erythema, pain, and swelling. The percentage of participants with one or more VRC-prompted injection-site AE was assessed.
Time Frame
Up to Day 5 after any vaccination
Title
Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card
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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and HZ-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed.
Time Frame
Up to ~28 days after Vaccination 4 (~Day 118)
Title
Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card
Description
Elevated temperature is defined as ≥100.4 °F (≥38.0 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.
Time Frame
Up to ~28 days after Vaccination 4 (~Day 118)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with an autoimmune disease
Clinically stable disease for at least 30 days before enrollment
Not likely to undergo hematopoietic stem cell transplantation during the study period
Receiving at least one parenteral or oral biologic agent, such as a Tumor Necrosis factor (TNF) alpha inhibitor, or a parenteral or oral non-biologic therapy, at a stable dose for at least 3 months, with no planned or anticipated changes
History of varicella, antibodies to VZV, or residence for at least 30 years in a country with endemic VZV infection, or if participant is less than 30 years old, attended primary or secondary school in a country with endemic VZV infection
Exclusion Criteria:
Prior history of Herpes Zoster (shingles) within 1 year before enrollment
Prior varicella or zoster vaccine
Active central nervous system lupus erythematosus requiring therapeutic intervention within 90 days of enrollment
Prior or planned therapy containing rituximab or other anti-Cluster of Differentiation (CD) 20 monoclonal antibodies from 3 months before enrollment through 28 days postdose 4
Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the time of enrollment
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
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
29126292
Citation
Eberhardson M, Hall S, Papp KA, Sterling TM, Stek JE, Pang L, Zhao Y, Parrino J, Popmihajlov Z. Safety and Immunogenicity of Inactivated Varicella-Zoster Virus Vaccine in Adults With Autoimmune Disease: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Clin Infect Dis. 2017 Oct 1;65(7):1174-1182. doi: 10.1093/cid/cix484.
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 Autoimmune Disease (V212-009)
We'll reach out to this number within 24 hrs