ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects
An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects
研究概览
详细说明
For this Phase 2 trial ABNCoV2-01, in a run in phase 6 adults (comprising of 3 subjects in each Group 1 and 2) will be vaccinated at 1 clinical trial site in a consecutive manner, with an at least 48 hours interval between the first and second subject of each group, then the second and third subject dosed on consecutive days, before opening up to full enrolment of the trial. Safety assessments will be based on solicited and unsolicited AE data (first week after vaccination) evaluated by an independent Data Monitoring Committee (DMC). After a positive DMC recommendation, enrolment to the rest of Group 1 and 2 of the trial will commence. Group 3 subjects will be enrolled after completion of Group 2 enrollment.
This phase 2 trial will evaluate a homologous prime-boost regimen with 100 µg ABNCoV2 in initially seronegative adult subjects (Group 1), as determined by a qualitative test for SARS-CoV-2 antibodies, compared to a single boost vaccination with 100 µg (Group 2) and 50 µg (Group 3) ABNCoV2 in initially seropositive subjects, as defined by a positive qualitative test for SARS-CoV-2 antibodies and either a history of SARS-CoV-2 vaccination or previous COVID-19 disease (Group 2 and 3) at least 90 days prior to planned trial vaccination.
Due to the timing of the addition of Group 3, enrollment into Group 2 will be completed prior to enrolling subjects into Group 3. Therefore, no randomization will be required for the seropositive subjects.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Berlin、德国、10629
- emovis GmbH
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Hamburg、德国、22143
- Velocity Clinical Research Hamburg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Seronegative (Group 1): negative qualitative test for SARS-CoV-2 antibodies at SCR.
Seropositive (Group 2 and Group 3): Previous COVID-19 disease or previously completed vaccination regimen with an authorized SARS-CoV-2 vaccine at least 90 days before planned trial vaccination and a positive qualitative test for SARS-CoV-2 antibodies at SCR. "Authorized" SARS-CoV-2 vaccine refers to authorization status at SCR, i.e., subjects can be eligible if the subject previously received investigational vaccines that have since been authorized for emergency use or granted full market licensure. Receipt of a single dose of an authorized COVID-19 vaccine regimen in subjects with a previous diagnosis of COVID-19 or a mix/match series of 2 doses of any authorized COVID-19 vaccine will be considered as a completed vaccination.
- General good health, without acute medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
- Body mass index (BMI) ≥18.5 and <40.
- Female subjects of childbearing potential (WOCBP) must agree to the use of an effective method of birth control from at least 30 days prior to administration of the vaccine until 30 days after the vaccination. Male subjects who are sexually active with a WOCBP must agree to the use of an effective method of birth control from the day of administration of the vaccine until 30 days after the vaccination.
- Negative human immunodeficiency virus antibody test (anti HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus (HCV).
Exclusion Criteria:
• Group 1 only: History of COVID-19 infection or previous vaccination with a licensed or candidate SARS-CoV-2 vaccine, or positive qualitative test for SARS-CoV-2 antibodies at SCR.
Groups 2 and 3 only: History of COVID-19 infection and subsequent receipt of more than one licensed or candidate SARS-CoV-2 vaccine.
- Positive test for SARS-CoV-2 infection at SCR.
- Pregnant or breastfeeding women.
- Subject has an acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses.
- History of or active autoimmune disease. History of Guillain-Barré syndrome or Reye's syndrome. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- Known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome.
- History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to SCR that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site.
- Laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline phosphokinase [AP], bilirubin, or creatinine values), pulse rate, blood pressure, or electrocardiogram (ECG) outside normal range at SCR and deemed clinically relevant by the investigator.
- Clinically significant mental disorder not adequately controlled by medical treatment.
- Active or recent history (within 6 months before SCR) of chronic alcohol abuse, intravenous drug abuse, or nasal drug abuse.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of anaphylaxis or severe allergic reaction to any vaccine.
- Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
- Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination.
- Recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to SCR, or planned blood donations during the active trial phase.
- Chronic systemic administration (defined as more than 14 days of >5 mg prednisone [or equivalent]/day), or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after the last vaccination. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed.
- Post organ transplant subjects, whether or not receiving chronic immunosuppressive therapy.
- Administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after the last vaccination. Receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery).
- Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:ABNCoV2 100ug single dose
ABNCoV2 100ug single dose.
Intervention type: Biological/Vaccine
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IM injection 100ug dose
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实验性的:ABNCoV2 50ug single dose
ABNCoV2 50ug single dose.
Intervention type: Biological/Vaccine
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IM injection 50ug dose
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实验性的:ABNCoV2 100ug two doses
ABNCoV2 100ug two doses 4 weeks apart.
Intervention type: Biological/Vaccine
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IM injection 100ug dose
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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SARS-CoV-2 neutralizing antibody titers
大体时间:2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects and after the single boost vaccination in initially seropositive subjects.
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SARS-CoV-2 neutralizing antibody titers
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2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects and after the single boost vaccination in initially seropositive subjects.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Subjects reporting any SAEs or AESIs assessed as related to trial vaccine.
大体时间:Within 8 days after vaccination
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Subjects reporting any SAEs or AESIs assessed as related to trial vaccine.
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Within 8 days after vaccination
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Subjects reporting any Grade 3 or higher AEs assessed as related to trial vaccine.
大体时间:8 days after vaccination
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Subjects reporting any Grade 3 or higher AEs assessed as related to trial vaccine.
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8 days after vaccination
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合作者和调查者
调查人员
- 首席研究员:Christine Grigat, MD、Velocity Clinical Research Hamburg
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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