EUCTR2010-023384-18-DE进行中（未招募）不适用
Randomized, double-blind, phase I/II 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. - Phase I/II Lyme Vaccine Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •* 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;
- •* Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures;
- •* Subject agrees to keep a daily record of symptoms for the duration of the study;
- •* If female of childbearing potential, subject 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 subjects in Cohort 5 only:
- •* Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 649
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •* Subject has a physician-diagnosed chronic illness related to 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 of or active infection with Babesia microtii or Anaplasma phagocytosum (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; NOTE: a 1.5 fold or greater increase over the upper limit of normal (ULN) for ALT and AST and a value of > 1.5 mg/dl for creatinine is considered clinically significant (see Section 12.4.4.2).
- •Furthermore, any laboratory parameters included in the FDA toxicity grading scale and graded as moderate or higher are to be considered clinically significant. Clinical significance of all other laboratory parameters will be evaluated by the investigator using his/her clinical expertise and judgment.
- •* 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); for subjects in Cohort 1 for whom the original exclusion criterion Subject has a history of testing positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this study” is applicable, testing will be performed at a later time point upon implementation of Amendment 2
- •* 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. Such treatment includes, but is not limited to: systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs;
- •* Subject has a history of anaphylaxis or severe allergic reactions;
- •*Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating;
- •* Subject has a body mass index > 35.0;
- •* Subject has received any blood products or immunoglobulins within 90 days prior to vaccination in this study;
- •* Subject has donated blood or plasma within 30 days prior to vaccination in this study;
- •* Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
- •* Subject has functional or surgical asplenia;
- •* Subject has a known or suspected problem with alcohol or drug abuse;
- •* Subject has participated in another clinical study involving an investigational product (IP), biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP, biological product or device during the course of this study;
- •* Subject is pregnant or lactating at the time of study enrollment;
- •* Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or
研究者
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