NCT04681092已完成1 期
Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Safety / Tolerability
研究概览
简要总结
Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study
详细描述
The study is designed as a combinatorial single-center open-label phase I and II clinical study design:
I. a phase I dose-finding and safety / tolerability study combined with, II. a phase II safety / efficacy study on the biological activity of AKS-452 against COVID-19.
To warrant more extensive development towards a phase III clinical study. The study will have a duration of approximately 4 months and will be executed at the University Medical Center Groningen, The Netherlands supported by the subsidizing party Akston Biosciences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SARS-CoV-2 serology by Akston (a quantitative anti-SARS-Cov-2 SP/RBD-specific IgG ELISA):
- •Undetectable or < 5 μg/mL titer and no known prior SARS-Cov-2 infection
- •Body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive
- •General good health, without significant medical illness, as determined via physical exam findings, ECG or vital signs
- •Note: one retest of vital functions and ECG is allowed within the screening window
- •No clinically significant laboratory abnormalities as determined by the investigator
- •Note: one retest of lab tests is allowed within the screening window
- •Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose and procedures required for the study and is willing to participate in the study
- •Willing to adhere to the prohibitions and restrictions specified in this protocol
- •Non-smoker (including prior smokers having stopped smoking for more than 3 months at time of screening) or non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during confinement.
- •Negative alcohol breath test and urine drug screen at screening and upon check-in at the clinical site.
- •Negative hepatitis panel (including hepatitis B surface Ag and anti-hepatitis C virus Abs) and negative human immunodeficiency virus Ab and Ag screens at screening
- •Female subjects should fulfil one of the following criteria:
- •At least 1 year post-menopausal (amenorrhea >12 months and/or follicle stimulating hormone >30 mIU/mL) at screening;
- •Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
- •Will use adequate forms of contraceptives from screening to discharge.
- •Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge
- •Note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, double barrier, sterilization and vasectomy
- •Female subject has a negative pregnancy test at screening and upon check-in at the clinical site.
- •Note: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at other (dosing) visits, in all women.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Pregnant of breastfeeding females
- •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, hematologic, rheumatologic, endocrine, autoimmune, or renal disease
- •Any laboratory test which is abnormal, and which is deemed by the Investigator(s) to be clinically significant
- •Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol
- •Current alcohol/illicit drug/nicotine abuse or addiction: history or evidence of current drug use or addiction (positive drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) or excessive use of alcohol at screening and Day -
- •Presence of any febrile illness (T > = 38.0°C or lab confirmed viral disease (PCR)) or symptoms suggestive of a viral respiratory infection within 1 weeks prior to vaccination
- •Use of corticosteroids (excluding topical preparations for cutaneous or nasal use) or use of immunosuppressive drugs within 30 days before inoculation
- •A history of anaphylaxis, history of allergic reaction to vaccine, known allergy to one of the components in AKS-
- •Mild allergies without angio-oedema or treatment need can be included if deemed not to be of clinical significance (including but not limited to allergy to animals or mild seasonal hay fever)
- •A history of asthma within the past 10 years, or a current diagnosis of asthma or reactive airway disease associated with exercise
- •Receipt of a licensed vaccine within 4 weeks prior to viral inoculation
- •Received any experimental SARA-CoV-2 vaccine or drug
- •Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to vaccination.
- •Receipt of another investigational agent within 30 days or 5 times the product half-life (whichever is longest) prior to vaccination
- •Shares household with /works with immunocompromised individual(s), adults with significant cardiopulmonary disease, persons with significant asthma, institutionalized elderly or elderly with functional disability
- •Deprived of freedom by an administrative or court order or in an emergency setting - Any condition that in the opinion of the principal investigator (PI) would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the protocol.
结局指标
主要结局
Safety / Tolerability
时间窗: 35 days
CTCAE-scoring
次要结局
- Immunogenicity(180 days)
研究者
研究点 (2)
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