NCT01504347已完成1 期
Randomized, Double-Blind, Phase 1/2 Clinical Study to Investigate the Safety and Immunogenicity of a Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) in Healthy Subjects Aged 18 to 70 Years
Baxalta now part of Shire16 个研究点 分布在 2 个国家目标入组 1,630 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,630
- 试验地点
- 16
- 主要终点
- Frequency and severity of injection site and systemic reactions
研究概览
简要总结
Section 1:
The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study.
Section 2:
An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Subject is 18 to 70 years old at the time of screening
- •Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
- •Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
- •If female of childbearing potential, presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- •Additional inclusion criterion for seropositive subjects in Section 2 only:
- •- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
排除标准
- •Subject has a physician-diagnosed chronic illness related to Lyme borreliosis (LB) or active LB
- •Subject has been treated for LB with antibiotics within 3 months of study entry
- •Subject had a tick bite within 3 weeks prior to screening or first vaccination
- •Subject has a history or active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (ehrlichiosis)
- •Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder
- •Subject has clinically significant abnormal laboratory values at screening
- •Subject currently has or has a history of immunodeficiency
- •Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- •Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response.
- •Subject has a history of anaphylaxis or severe allergic reactions
- •Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
- •Subject is pregnant or lactating at the time of study enrollment
- •Additional exclusion criterion for subjects in Section 1 and seronegative subjects in Section 2:
- •- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
结局指标
主要结局
Frequency and severity of injection site and systemic reactions
时间窗: Within 7 days after each vaccination (i.e. Days 8, 36 and 64)
Antibody response to the vaccine
时间窗: 28 days after the third vaccination (= Day 85)
次要结局
- Frequency and severity of adverse events(28 days after each vaccination and during entire study period)
- Seroconversion rate (at least 4-fold increase of each rOspA type-specific Immunoglobulin G (IgG) titer) as compared to baseline(28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination)
- Fold increase in antibody titer compared to baseline(28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination)
- Antibody response(At baseline, 28 days after each vaccination (i.e. Days 29, 57 and 85), 180 and 270 days after the first vaccination (Day 181, Day 271) and 180 days after the booster vaccination (Day 361 or Day 451 - 546))
研究者
研究点 (16)
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