A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 354
- 主要终点
- Percentage of Participants With a Serious Adverse Event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: V212 (Biological)
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.
干预措施: Placebo (Biological)
结局指标
主要结局
Percentage of Participants With a Serious Adverse Event
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card(Up to Day 5 after any vaccination)
- Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card(Up to ~28 days after Vaccination 4 (~Day 118))
- Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card(Up to ~28 days after Vaccination 4 (~Day 118))