EUCTR2020-003734-20-IT进行中（未招募）1 期
A Phase I/II study to assess the safety and immunogenicity of COVID-eVax, a candidate plasmid DNA vaccine for COVID-19, in healthy adult volunteers. - COVID-eVax
Takis S.r.l.0 个研究点目标入组 160 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •1. Signed and dated informed consent obtained before undergoing any study-specific procedure
- •2. Healthy male or female aged =18 and = 65 years
- •3. Body Mass Index >18.5 and =30 kg/m2
- •4. Vital signs within the following values or ranges:
- •a. Body temperature = 37,5 °C
- •b. Pulse frequency =51 and =100 beats per minute
- •c. Diastolic BP =60 mmHg, = 90 mmHg
- •d. Systolic BP = 90 mmHg, = 140 mmHg
- •e. Respiratory rate = 12 breaths per minute, = 16 breaths per minute
- •5. ECG at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome are absolute exclusion criteria)
- •6. Laboratory examinations within normal reference range or with no clinically significant abnormalities
- •7. Absence of any respiratory and flu-like symptoms
- •8. Non-pregnant women of childbearing potential, willing to practice a highly effective method of contraception from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal
- •9. For sexually active men with a female partner of childbearing potential, willingness to use a condom and to refrain from donating sperm from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal
- •10. Agreement to refrain from blood donation during the course of the study
- •11. Able and willing to comply with all study procedures.
- •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 152
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. History of confirmed infection with SARS-CoV-2, by positive nasopharingeal swab or by positive serological test for SARS-CoV-2 antibodies
- •2. Positive serological test for SARS-CoV-2 antibodies at screening
- •3. Subjects at high risk of SARS-CoV-2 infection prior or during the trial, including:
- •a. subjects with any known exposure in the 4 weeks before enrolment
- •b. close contacts of suspected or confirmed COVID-19 or SARS-CoV-2 infection cases
- •c. subjects quarantined for any reason
- •d. frontline healthcare professionals working in Emergency departments, ICU and other higher risk healthcare areas
- •4. Positive serological tests for:
- •a. Hepatitis B surface antigen (HBsAg)
- •b. Hepatitis C antibodies
- •c. Human Immunodeficiency Virus (HIV) antibodies
- •5. Subjects with any of the following specific contraindications, even in medical history:
- •a. Type 2 diabetes or glucose intolerance, even if controlled
- •b. Hypertension, even if controlled
- •d. Any cardiac disease, even if not evident at ECG
- •e. Pacemaker
- •6. Use of any investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding screening
- •7. Prior administration of any vaccine in the 2 weeks preceding screening
- •8. Administration of any monoclonal or polyclonal antibody product within 4 weeks preceding screening
- •9. Administration of any blood product within 3 months of screening
- •10. Current or prior administration, within the 6 months preceding screening, of immunosuppressants (inhaled, topical skin and/or eye drop-containing corticosteroids; a short course of corticosteroids, defined as =20 mg/day prednisone or equivalent for 10 days, and low-dose methotrexate are allowed until 4 weeks prior to screening)
- •11. Any prior major surgery or any chemio- or radiation therapy within 5 years of screening
- •12. Current or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections
- •13. Active, known, or suspected autoimmune disease (except mild psoriasis, wellcontrolled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy)
- •14. Bleeding disorders (e.g. coagulopathy or platelet disorder or coagulation factor deficiency) or prior history of significant bleeding or bruising following IM injections or venipuncture
- •15. History of seizures or mental illness
- •16. History of allergy to vaccines or of severe allergic reaction of any kind
- •17. Metal implants within 20 cm of the planned site(s) of injection
- •18. Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection
- •19. Any abnormality or permanent body art (e.g. tattoos) that would interfere with the ability to observe local reactions at the injection site in the deltoid area
- •20. History of alcohol or drug abuse during the 12 months preceding the screening
- •21. Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study
- •22. Breastfeeding
- •23. Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject’s safety during trial participation.
研究者
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