NL-OMON50898已完成不适用
First-in-human trial of the Coronavirus virus-like particle subunit vaccine ABNCoV2 in SARS-CoV-2-naïve adult volunteers in good health (COUGH-1) - Safety and tolerability of ABNCoV2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
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 99（—）
入选标准
- •1. Subject must sign written informed consent to participate in the trial.
- •2. Subject is able to understand planned study procedures and demonstrate
- •comprehension of the protocol procedures and knowledge of the study by passing
- •a quiz (assessment of understanding). Subjects must score at least 80% correct
- •on a multiple-choice quiz. If they do not score 80% on the initial quiz, the
- •protocol information will be reviewed with them, and they will have the
- •opportunity to retest.
- •3. In the opinion of the investigator, the subject can and will comply with the
- •requirements of the protocol.
- •4. Subjects are available to attend all study visits and are reachable by phone
- •throughout the entire study period from day -1 until 24 weeks following last
- •vaccination (end of study).
- •5. Subject is a male or non-pregnant and non-lactating female age * 18 and * 55
- •years and in good health at time of ABNCoV2 administration.
- •6. Subject agrees to their general practitioner (GP) being informed about
- •participation in the study and agrees to sign a form to request the release by
- •their GP, and medical specialist when necessary, of any relevant medical
- •information concerning possible contra-indications for participation in the
- •study to the investigator(s).
- •7. The subject agrees to refrain from blood donation to Sanquin or for other
- •purposes throughout the study period according to current Sanquin guidelines.
- •8. Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, current bilateral tubal
- •ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
- •All other female subjects must agree to use continuous adequate contraception
- •for the duration of the study. Female subjects must have a negative pregnancy
- •test at the inclusion visit.
排除标准
- •1. Any clinically significant abnormal finding on clinical examination or
- •laboratory screening tests according to the FDA Toxicity Grading Scale for
- •Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical
- •2. History of COVID-19 infection.
- •3. Chronic use of immunosuppressive drugs or other immune modifying drugs
- •within six months prior to study onset (inhaled and topical corticosteroids and
- •oral anti-histamines exempted) or expected use of such during the study period.
- •4. Positive urine toxicology test for cannabis, cocaine or amphetamines at
- •5. Screening tests positive for SARS-CoV-2, SARS-CoV-2 antibodies, Human
- •Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), or Hepatitis C
- •Virus (HCV).
- •6. Receipt of any investigational or non-registered product (drug or vaccine)
- •other than the study product in the 30 days preceding enrolment or during the
- •study period.
- •7. Participation in any other clinical study in the 30 days prior to the start
- •of the study or during the study period.
- •8. Immunization with any vaccines within the past four weeks or planned receipt
- •of a vaccine during the study period with the exception of a licensed
- •SARS-CoV-2 vaccine, given within the framework of the national SARS-CoV-2
- •vaccination campaign. The time between last vaccination with ABNCoV2 and a
- •SARS-CoV-2 vaccine provided by the campaign shall be at least 4 weeks.
- •9. Known hypersensitivity to any of the vaccine components (adjuvant or
- •10. Administration of immunoglobulins and/or any blood products within the
- •three months prior to the first dose of ABNCoV2 or planned administration
- •during the study period.
- •11. Previous participation in a COVID-19 vaccine study.
- •12. Body Mass Index (BMI) >35 kg/m2.
- •13. Pregnancy, lactation or intention to become pregnant during the study
- •14. History of drug or alcohol abuse interfering with normal functioning in the
- •five years preceding enrolment.
- •15. Being an employee or student of the department of Medical Microbiology of
- •the Radboudumc, or a person otherwise related to the investigator other than a
- •professional relationship for clinical trial purpose only.
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