NL-OMON45727已完成4 期
A study to characterize the humoral and cellular response following simultaneous immunization with a neo-antigen (KLH) and a recall antigen (tetanus) in healthy volunteers - KLH and tetanus toxoid immunization in healthy volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Eligible subjects must meet all of the following inclusion criteria at screening:
- •1. Healthy male subjects, 18 to 45 years of age (inclusive). The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history and a complete physical examination including vital signs, laboratory measurements and 12-lead ECG;
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;
- •3. Previous immunization with tetanus toxoid as reported by the subject;
- •4. Willing to give written informed consent and willing and able to comply with the study protocol.
排除标准
- •Eligible subjects must meet none of the following exclusion criteria at screening:
- •1. Any disease associated with immune system impairment, including auto-immune diseases, HIV, any confirmed history of severe allergic reaction and transplantation patients;
- •2. Known infection requiring antibiotic therapy within the last three months prior to the study
- •3. Previous known exposure to Immucothel® or KLH;
- •4. Any adverse immune reaction following immunization with tetanus toxoid;
- •5. Known allergy against Thiomersal®, which is a stabilizer in the tetanus toxoid immunization;
- •6. Received immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study;
- •7. Use of medication (prescription or over-the-counter) within 21 days of the first study day, or less than 5 half-lives (whichever is longer), and during the course of the study;
- •8. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
- •9. Previous participation in an investigational drug or device study involving the dosing of a biological targeted at any immune pathway within one year prior to screening;
- •10. Loss or donation of blood over 500 mL within three months prior to screening;
- •11. Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the subject or may preclude the subjects* successful completion of the clinical trial.
- •12. History of Schistosomiasis (infection with Schistosoma parasite).
- •13. History or current nicotine use in access of 5 cigarettes per day, or unable not to smoke during the course of the study, defined as between the screening visit and the final visit.
- •14. Tetanus toxoid immunization within the last 10 years before study participation
研究者
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