A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
- Conditions
- Herpes Zoster
- Interventions
- Biological: V212Biological: Placebo
- Registration Number
- NCT01527383
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V212 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. Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Serious Adverse Event Up to ~28 days after Vaccination 4 (~Day 118) 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.
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Baseline and ~28 days after Vaccination 4 (~Day 118) 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 Baseline and ~28 days after Vaccination 4 (~Day 118) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card Up to Day 5 after any vaccination 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 Elevated Temperature Prompted on the Vaccination Report Card Up to ~28 days after Vaccination 4 (~Day 118) Elevated temperature is defined as ≥100.4 °F (≥38.0 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.
Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card Up to ~28 days after Vaccination 4 (~Day 118) 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.